2o16 annual report · fellowship in 2o17 with a focus on peritoneal dialysis (pd), particularly the...

2O16Annual ReportAustralasian Kidney Trials Network

2 AKTN | Annual Report 2016

The Australasian Kidney Trials Network operates under the Centre for Health Services Research at the University of Queensland’s Faculty of Medicine. It is a not for profit investigator-initiated clinical trials organisation based at the Princess Alexandra Hospital, Woolloongabba, Queensland.

Australasian Kidney Trials NetworkFaculty of Medicine (CHSR)The University of QueenslandTranslational Research Institute, Level 537 Kent Street, Woolloongabba, QLD 41O2

T: +61 7 3443 7881E: [email protected]: aktn.org.au

3AKTN | Annual Report 2016

Contents

Introduction5 About the AKTN6 Executive Message7 Snapshot

Staff and Staff Activities9 Our Staff1O Staff Activities

Governance Information13 Executive Operations Secretariat13 Advisory Board14 Scientific Committee15 Trial Steering Committees16 Working Groups17 Data & Safety Monitoring Board

Our Trials19 Active Trials22 Trials in Development24 Completed Trials

Financial Overview28 Financial Overview

Partners/Sponsors31 Australia & New Zealand31 International Collaborators

Publications32 Publications


Making a difference through clinical trials

The Australasian Kidney Trials Network (AKTN) is a not-for-profit collaborative research group that designs, conducts and supports investigator-initiated clinical trials with the aim of improving life for people living with Chronic Kidney Disease (CKD).

To date, the AKTN has successfully completed five trials with a record number expected to be running in 2O17. Our research helps bring evidence to medical practice and in doing so improve outcomes for CKD patients. To learn more about the AKTN and how you can get involved, please visit aktn.org.au.


Executive Message

This year has been an exciting year for the Australasian Kidney Trials Network with our team achieving some significant milestones, including the development of two registry based randomised controlled trials. The BEST-Fluids trial (a transplant trial, p. 22) and RESOLVE (a haemodialysis (HD) trial run by The George Institute, p. 21) trial represent a novel and pragmatic approach to clinical research that has not been done before in the kidney care space.

Two major trials in the chronic kidney disease (CKD) population completed active recruitment this year. The IMPROVE-CKD and the CKD-FIX trials enrolled their last patients at the end of December. Both trials will commence 2 years of follow-up until December 2O18, and results analysed and published in 2O19. Both the PDOPPs study (a peritoneal dialysis (PD) observational study) and PEXIVAS trial (an international glomerulonephritis trial) continued to recruit from ANZ hospitals during 2O16, with recruitment expected to be completed in 2O17.

In a coup for the FAVOURED Trial Steering Committee the main results of the trial were

accepted for publication in the prestigious JAMA Internal Medicine. The FAVOURED study (an HD trial) was the first AKTN trial to commence recruitment and took almost eight years to complete. It was brought home through the tireless efforts of the team including trial site staff, the Trial Steering Committee and the AKTN Operations Secretariat. Congratulations to all the team – we learned and achieved so much over the course of this study, with these valuable lessons informing subsequent AKTN trial design and conduct.

Our very own David Johnson and Yeoungjee Cho received NHMRC fellowship grants. Yeoungjee, an AKTN Clinical Trialist, will commence her Early Career Research Fellowship in 2O17 with a focus on Peritoneal Dialysis (PD), particularly the factors contributing to early technique failure, and the role of urgent-start PD programs. David’s Practitioner Fellowship will allow him strategic relief from his clinical commitments to enhance the productivity and impact of AKTN’s research output on policy and practice in Nephrology.

Other new research projects currently on track for commencement in 2O17 include the REMOVAL-HD study (haemodialysis with Baxter’s THERANOVA, a new mid cut-off HD

dialyser) and the TEACH-PD study (a PD nurse-led “train the trainer” intervention). These exciting studies bring together new partnerships and collaborations in line with the growing importance of the AKTN as an ‘enabler’ for investigator-initiated research in kidney disease.

2O16 also saw the launch of the inaugural BEAT-CKD Research Forum in Sydney, which gathered together researchers, key opinion leaders, patients and clinicians for two days of engaging presentations and discussion. The Forum also offered a unique opportunity to forge new collaborations and partnerships. The 2O17 BEAT-CKD Research Forum will be held in Adelaide and is eagerly anticipated by the kidney care community.

This is an exciting time for the AKTN as we enter a period of increased opportunity for global collaboration with international, multi-disciplinary partners. The BEAT-CKD Program, of which AKTN is one of the four national research and translation platforms, has created increased scope to explore novel research methods and ways of conducting clinical research that represent the future of health research. The AKTN is uniquely positioned to take advantage of these opportunities as we enter this new era.

We would like to thank all our supporters, particularly those working in renal units across Australia and New Zealand, whose goodwill and support are critical to the success of the AKTN’s aim of making a meaningful difference to the lives of people and families living with kidney disease.

A/Prof Carmel HawleyEOS Chair

Prof Neil BoudvilleSC Chair


2O16 Snapshot

1O5Publications

5Active Trials

3Trials in

Development

5Completed

Trials

Over $2,OOO,OOO worth of new grant funding


Staff and Staff Activities


Our Staff

Executive Operations SecretariatCarmel Hawley (Chair)David Johnson (Deputy Chair)Neil BoudvilleVlado PerkovicMeg Jardine

Clinical TrialistsSunil BadveMagid FahimYeoungjee ChoRathika Krishnasamy

Head, Biostatistics & Data ManagerElaine Pascoe

BiostatisticianDarsy Darssan

Clinical Operations ManagerDonna Reidlinger

Clinical Project ManagerLaura Robison

Data ManagerLiza Vergara

Clinical Research AssociatesPeta-Anne Paul-BrentAndrea ValksJulie HollidayStephanie SmithFlora Chin

Communications OfficerAmelia Edgley

Executive Support OfficerJospehine Parry

Research Assistant Jean Helyar


Staff Activities

A/Prof Meg Jardine (2nd from left) and A/Prof Carmel Hawley (far right) at a “CSN/ANZSN in America” debate along with Dr Peter Blake (1st), Dr Amit Garg (3rd) and Dr Jeff Perl (4th).

Laura Robison (left) and Peta-Anne Paul-Brent (right) presenting their trial posters at the Princess Alexandra Hospital Health Symposium.

A/Prof Carmel Hawley (left) and Dr Magid Fahim (right) presenting at the BEAT-CKD Research Forum 2O16.

Dr Sunil Badve graduating with his PhD at the University of Queensland.

Dr Hooi and A/Prof Carmel Hawley at ANZSN 2O16 in Perth.


Dr Michael Collins (1st), Laura Robison (2nd) and Donna Reidlinger (3rd) at a dinner for ACTA 2O16 in Melbourne.

Prof David Johnson (left) and Dr Yeoungjee Cho (right) each receive a prestigious NHMRC Fellowship grant for their research.

A/Prof Carmel Hawley presenting at the Kidney Health Australia (KHA) Research Walk 2O16.

A/Prof Carmel Hawley at one of the faculty’s “friendly Nephrology debates”.

The AKTN team attending the 2O16 KHA Research Walk.

Spreading our Message in 2O16

AKTN Staff and stakeholders were hard at work this year attending various conferences, presentations, debates, events and ceremonies and providing trial updates, thought leadership and support for initiatives for the kidney care community.


Governance Information


Executive Operations Secretariat

Members Carmel Hawley (AKTN Chair)David Johnson (AKTN Deputy Chair)Vlado Perkovic Neil Boudville Meg Jardine Magid Fahim Yeoungjee Cho Elaine Pascoe Alicia MorrishDonna ReidlingerLaura Robison

Sunil BadveRathika Krishnasamy

The Queensland-based Executive Operations Secretariat (EOS) is the hub of the Australasian Kidney Trials Network. It is from the Brisbane office that the AKTN multi-centre clinical trials are coorindated and educational opportunities managed. The Operations Secretariat is the "engine room" of the organisation being responsible for the appropriate data, human resources and financial management operations of the network. The EOS consists of the following members.

Advisory Board

Members David Harris (Chair) Mark Bowles Val Gebski Stephen Nicholls

Ann BonnerAlan Cass

The Advisory Board assesses the overall management of the Network, including its financial and organisational competence, strategic direction and performance. The inaugural chair is Professor David Harris from the department of Renal Medicine at Westmead Hospital. The board meet at least once annually at a face-to-face meeting organised by the AKTN Operations Secreteriat. The following is a list of current members which includes three Nephrologistists with extensive clinical research experience, an expert in financial/business management, a statistician with specialist clinical trial expertise and an academic research nurse.


Scientific Committee

MembersNeil Boudville (Chair)Meg Jardine (Deputy Chair)Fabian Marden (Consumer Rep.)Carmel Hawley (AKTN EOS Chair)David Johnson (AKTN EOS Deputy Chair)Elaine Pascoe (AKTN)Vlado Perkovic Chen Au Peh Jonathan Craig Josephine Chow Katrina Campbell Martin Gallagher Matthew Jose

Matthew Roberts Nigel Toussaint Rob MacGinley Rob Walker Solomon Cohney Stephen McDonald Suetonia Palmer Wai LimSunil Badve (AKTN; ex-officio) Magid Fahim (AKTN; ex-offcio) Yeoungjee Cho (AKTN; ex-officio) Donna Reidlinger (AKTN; ex-officio)Rathika Krishnasamy (AKTN; ex-officio)

The role of the Scientific Committee is to provide scientific leadership to the AKTN by providing peer review of proposals submitted to the AKTN with regard to scientific merit, feasibility and clinical relevance, prioritisation of clinical trials and other network activity, voting on the AKTN's involvement in individual trials, and advising on audience and content of educational sessions. The following are the terms of reference for the committee.

• Provide an evaluation of clinical trials proposed for coordination/facilitation to ensure they are of scientific value, statistical and logistical feasibility and conform to ethical guidelines

• Be involved as a Chair or Member of a Working Group• Approve and implement trial selection criteria and/or scientific review mechanisms• Decide by vote on whether to co-ordinate or facilitate proposed trials• Provide advice on content and structure of educational and promotional activities• Receive reports on progress from principal investigators• Report annually to the Advisory Board


Trial Steering Committees

HONEYPOT TrialDavid Johnson (Chair)Alan CassCarmel HawleyJanak De ZoyzaPaul SnellingSteven McTaggartGeoffrey PlayfordCarolyn ClarkCharles ThompsonLiza VergaraElaine Beller

FAVOURED TrialAshley Irish (Chair) David VossAmanda RobertsonAlan CassCarmel HawleyVlado PerkovicSharan DograTrevor MoriKevan PolkinghornePeter KerrElvie HaluszkiewiczDavid GraceyAmanda MatherStephen McDonaldHooi Lai SeongColin HutchinsonChris McIntyrePeta-Anne Paul-BrentMichael WatsonAlicia MorrishCharles Thompson

HERO TrialDavid Johnson (Chair)Alan CassVlado PerkovicCarmel HawleyStephen McDonaldRowan Walker

Rob FassettPaolo FerrariGenie PedagogosCarl KirkpatrickRichard PoonEmanuel D'AlmeidaAlicia MorrishSunil BadveCharles ThompsonDonna ReidlingerLiza Vergara

PEXIVAS TrialChen Au Peh (Chair)Rendall FaullJanak de ZoysaPeter KerrRobyn LanghamGiles WaltersVlado PerkovicSunil BadveAlicia MorrishDonna ReidlingerPeta-Anne Paul-BrentAndrea Valks

BLOCADE TrialMatthew Roberts (Chair)Alan CassCarmel HawleyHenry KrumVlado PerkovicAmit GangAndrew TonkinFrank IerinoNikky IsbelHelen PilmoreElaine PascoeLiza Vergara

IMPROVE-CKD TrialEugenie Pedagogos (Co-Chair)

Nigel Toussaint (Co-Chair)Carol PollockRandall FaullGrahame ElderKatrina CampbellLen LauNeil BoudvillePeter KerrRob WalkerSteve HoltVlado PerkovicCarmel HawleySunil BadveGeoffrey BlockKevan PolkinghorneMeg JardineEdward SmithSylvia ChenJames CameronAngela WangSharon BurtonKathy HillHooi La SeongSamantha Hand

CKD-FIX TrialDavid Johnson (Chair)Sunil BadveNeil BoudvilleFiona BrownAlan CassPhilip ClarkeNicola DalbethRic DayJanak de ZoysaBettina DouglasRobert FassettRandall FaullDavid HarrisCarmel HawleyGraham JonesJohn KanellisSuetonia Palmer

Elaine PascoeVlado PerkovicGopala RanganPeta-Anne Paul-BrentRob WalkerGiles WaltersLaura RobisonFlora ChinJulie Holliday

RESOLVE TrialCarmel Hawley (Chair)Peter Kerr (Deputy Chair)Meg JardineMatthew RobertsMatthew JoseNeil BoudvilleAngus RitchieKathy HillPaula DunnAmanda MatherPhilip ClaytonCarol PollackJohan RosmanPaul SnellingSamantha HandRathika KrishnasamyBrendan SmytheAnushka PaulNickolas GrayLaura RobisonPeta-Anne Paul-Brent

For AKTN-coordinated trials, the role of the Trial Steering Committee (TSC) is to develop the protocol, provide input into the development of trial resources, and monitor the conduct of the trial via feedback from the Trial Clinical Research Associate (CRA) or Site Investigator Committee. The aim is to ensure participant safety, scientific rigor and data validity. The following is a list of members for each committee (since inception).


Working Groups

AKI Working GroupMartin Gallagher (Chair) Alan CassRinaldo BellomoRobyn LanghamShay McGuinnessVincent DintiniZoltan Endre

CKD-GN Working GroupNigel Toussaint (Chair)Alan ParnhamChen Au PehChris HoodCarmel HawleyGiles WaltersJean TanJoshua KausmanKatrina CampbellLisa JeffsSuet-Wan ChoySunil BadveVlado Perkovic

HD Working GroupMeg Jardine (Chair)Matthew RobertsAmanda MatherCarmel HawleyColin HutchinsonFabian MarsdenJoanna DunlopKevan PolkinghorneNicholas GraySamantha Hand

Methods Working GroupMagid Fahim (Chair)Elaine PascoeJonathan CraigPhil ClaytonSuetonia Palmer

PD Working GroupMatthew Jose (Chair)Carmel HawleyDavid Johnson

Jeff WongJo-Anne MoodieJosephine ChowLouis HuangNeil BoudvilleRob MacGinleyYeoungjee Cho

Transplant Working GroupWai Lim (Chair)Allison TongAron ChakeraGermaine WongJohn KanellisKatherine BaracloughMichael CollinsNeil BoudvillePhil ClaytonRob CarrollRoss FrancisSolomon CohneySteve McTaggart

The AKTN Working Groups were originally borne out of the Scientific Committee and are responsible for: generating trial ideas, providing scientific evaluation of proposals submitted to the network for peer review, developing AKTN research priorities, liaising with the Operations Secretariat to provide advice and assistance on trial protocol development, and promotion and education on specialty-specific trials across ANZ. The following is a list of our working groups and current members.


D&S Monitoring Boards (DSMB)

Current DSMB

IMPROVE-CKD and CKD-FIX Trials Bruce Neal (Chair)Andrew Forbes David Wheeler Christoph Wanner

Past DSMB

HERO, FAVOURED and HONEYPOT Trials Andrew Tonkin (Chair) Andrew Forbes Adeera Levin David Wheeler

BLOCADE TrialAdeera Levin (Chair)Andrew Martin David Hare David Wheeler

A Data & Safety Monitoring Board (DSMB) is an independent body of clinicians, statisticians, and individuals from other disciplines whose task is to review accumulating trial data and make recommendations to the Trial Steering Committee concerning the conduct of the trial and whether the trial should continue in its current form. The primary objective of a DSMB is to ensure that the trial remains appropriate and safe for individuals who have been, or are still to be, enrolled. Other responsibilities include monitoring trial progress and overall quality of trial conduct.

The AKTN currently has one DSMB which is responsible for monitoring accumulating data for the IMPROVE-CKD and CKD-FIX trials. The DSMB met in March 2015 and recommended both trials continue under their current protocols.

Members of current and past DSMBs and the trials they monitored are as follows.


Our Trials


Active Trials

Plasma EXchange and glucocorticoids In anti-neutrophil cytoplasm antibody associated systemic VASculitis

Principal Investigator: Dr Chen Au PehClinical Research Associate: Andrea Valks

Trial Summary:ANCA-associated systemic vasculitis is a life-threatening auto-immune disease which targets small blood vessels in different tissues and organs of the body. Current standard treatment regimens still have poor outcomes, and although high doses of glucocorticoids early in disease reduce disease activity, they increase the risk of infection. There is a need for therapies with reduced toxicity while improving disease control. The PEXIVAS project will investigate whether plasma exchange, in addition to immunosuppressive therapy and glucocorticoids, will reduce death and the development of severe kidney failure due to this disease. Additionally, the project will also look at whether using a reduced dose of glucocorticoids is just as effective as larger doses in lessening the infectious complications of treatment and improving quality of life for patients.

Status: The PEXIVAS trial completed recruitment in September 2O16 and the follow up end date is July 2O17.For more information, please visit www.aktn.org.au/pexivas/

The Australian Peritoneal Dialysis Outcomes and Practice Patterns Study

Principal Investigator: Professor David JohnsonClinical Project Manager: Laura RobisonTrial Number: AKTN 13.O1

Trial Summary:End-stage kidney disease (ESKD) is increasingly recognised as a major public health problem in Australia and worldwide. Peritoneal dialysis represents an important treatment option for ESKD. Compared with haemodialysis (HD), peritoneal dialysis (PD) is associated with superior survival in the first few years, better quality of life, superior patient satisfaction and lower treatment costs. PDOPPS is a multicentre global study that is designed to advance our understanding of optimal practices for peritoneal dialysis (PD) patients worldwide. The aim is that the study will increase the appropriate use of PD, extend technique survival, reduce mortality, and improve quality of life for PD patients.

Status: Current enrolment 425 out of 64O. 19 sites open to recruitment. Additional NHMRC funding requested in 2O17. For more information, please visit www.aktn.org.au/pdopps/


IMpact of Phosphate Reduction On Vascular End-points in Chronic Kidney Disease

Principal Investigator: A/Prof Nigel Toussaint and Dr Eugenie PedagogosClinical Research Associate: Andrea ValksTrial Number: AKTN 1O.O1

Trial Summary:Chronic Kidney Disease (CKD) is a significant health problem and is associated with an increased risk of cardiovascular (CV) disease. Vascular calcification and arterial stiffness (stiffening of the blood vessels and arteries) are very common in people with CKD, and are linked to increased death from CV events. This study aims to examine the ways in which treatment with a phosphate binder, Lanthanum Carbonate, may reduce vascular calcification and arterial stiffness to decrease CV events.

Status: Recruitment is expected to close late January 2O17 with a follow up end date of November 2O18.For more information, please visit www.aktn.org.au/improve-ckd/

A randomised Controlled trial of slowing of Kidney Disease progression From the Inhibition of Xanthine oxidase

Principal Investigator: Professor David JohnsonClinical Research Associate(s): Laura Robison, Julie Holliday, Flora ChinTrial Number: AKTN 1O.O2

Trial Summary:Chronic Kidney Disease (CKD) is a major public health problem affecting over 1.5 million Australians and is associated with increased risk of death, heart disease and progression to end-stage kidney disease (ESKD). Current treatments to slow progression to ESKD are limited. The CKD-FIX trial aims to find out whether treatment with allopurinol, a commonly used drug for gout prevention, safely and effectively slows CKD progression. This could lead to significant health and economic benefits.

Status: The CKD-FIX trial expects to enrol its last patient December 2O16 with a follow up end date of December 2O18.For more information, please visit www.aktn.org.au/ckd-fix/


Randomised Evaluation of SOdium dialysate Levels on Vascular Events: A Cluster Clinical Trial

Global Principal Investigator: A/Prof Meg JardineNZ Principal Investigator: Dr Mark MarshallAustralia Lead: A/Prof Carmel HawleyClincial Research Associate: Peta-Anne Paul-Brent

Trial Summary:Research has shown that the use of lower levels of dialysate sodium (DNa+) in HD patients improves certain patient outcomes. This has prompted some HD units to reduce their levels of DNa+. However, other studies has shown that lower levels of DNa+ may actually adversely affect patient outcomes. The RESOLVE trial aims to generate much-needed evidence confirming whether a lower DNa+ level does in fact reduce the vital patient outcomes of major cardiovascular event and death or whether it is perhaps more harmful.

Status: Current enrolment stands at 116 participants at one site with the first participant visit in June 2O16 and last visit in June 2O22.For more information, please visit www.aktn.org.au/resolve/

*The RESOLVE Study is run by The George Institute and the Australasian Kidney Trials Network is collaborating.


Trials in Development

Better Evidence for Selecting Transplant Fluids

Principal Investigator: Dr Michael CollinsClinical Research Associate: Peta-Anne Paul-BrentTrial Number: AKTN 15.O2

Trial Summary:Intravenous fluids are a critical aspect of care when performing kidney transplants. Currently, isotonic sodium chloride (0.9% saline) is the standard of care in fluids at most transplant centres. This solution, however, may be harmful due to its high chloride content (relative to plasma) and may promote acute kidney injury which can lead to dangerous outcomes for the patient. The BEST-Fluids study is investigating a new fluid, Plasmalyte, to see if it is better than the standard O.9% saline solution in kidney transplants. If so, it may result in significant cost savings and offer better outcomes for kidney transplant patients.

Status: The trial protocol has been developed and pending ethics approval and funding, recruitment is to begin in 2O17. For more information, please visit www.aktn.org.au/best-fluids/

Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes

Principal Investigator: A/Prof Josephine Chow and Prof Neil BoudvilleClinical Research Associate: Peta-Anne Paul-BrentTrial Number: AKTN 14.O1

Trial Summary:This project will develop and evaluate a standardised “train the trainer” education package for Australian Peritoneal Dialysis (PD) nurses using online training modules. The package will be developed by key experts from the Home Network and piloted at two PD units for feedback about the modules from site staff and patients. It is believed that consistent training of clinical staff will help PD patients stay on home dialysis longer and with fewer problems leading to better health and economic outcomes.

Status: The Home Network is currently finalising the online training modules.For more information, please visit www.aktn.org.au/teach-pd/


A tRial Evaluating Mid cut-Off Value membrane clearance of Albumin and Light chains in HaemoDialysis patients

Principal Investigator: Dr Colin HutchisonClinical Research Associate: Peta-Anne Paul-BrentTrial Number: AKTN 15.O1

Trial Summary:Haemodialysis remains a principal renal replacement modality for patients with end stage renal disease. Despite the efficacy of haemodialysis as a treatment to replace essential kidney functions, such as fluid and acid-base balance, the morbidity and mortality of patients receiving haemodialysis remains high when compared with the general population. Middle molecules are a well described class of uraemic solutes which have been linked to both the reduced quality of life and survival associated with end stage kidney disease. To date larger middle molecules have been inadequately removed by haemodialysis strategies. The mid cut-off dialyser Theranova represents a new class of dialysis membranes with the ability to remove nearly all middle molecules. The primary objective of the REMOVAL-HD study is to determine if standard haemodialysis using the Baxter Theranova dialyser in a chronic haemodialysis population can significantly decrease serum concentrations of large middle molecules without resulting in a significant loss of albumin.

Status: Nine sites are finalising the ethics and governance approval processesFor more information, please visit www.aktn.org.au/removal-hd/


Completed Trials

HOney versus Nasal Eradication of staphYlococci for the Prevention Of Tenckhoff infections in PD

Principal Investigator: Prof David JohnsonClinical Research Associate: Liza VergaraTrial Number: AKTN O6.O2

Trial Results:The HONEYPOT trial showed that topical honey is not more effective than standard practice in the prevention of catheter-associated infections in peritoneal dialysis patients. It is therefore recommended that clinicians continue standard practice. Results of the study have been published in the Lancet Infectious Diseases and Peritoneal Dialysis International.

For more information, please visit www.aktn.org.au/honeypot/

Omega-3 Fatty Acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease

Principal Investigator: Dr Ashley IrishClinical Research Associate: Peta-Anne Paul-BrentTrial Number: AKTN O6.O1

Trial Results:The FAVOURED study is unable to recommend the use of fish oil or aspirin for the prevention of AVF failure. Additional studies and strategies to reduce the current unacceptably high AVF failure rate are urgently required. The results of the study have been presented at the ASN Kidney Week in November 2O15 and the final results are to be published in JAMA Internal Medicine early 2O17.

For more information, please visit www.aktn.org.au/favoured/


Beta-blocker to LOwer CArdiovascular Dialysis Events Feasibility Study

Principal Investigator: Dr Matthew RobertsClinical Research Associate: Liza VergaraTrial Number: AKTN O8.O1

Trial Results:The BLOCADE trial demonstrated the need for a very large pool of patients from which to recruit with greater international collaboration required. Results of the study have been published in the American Journal of Kidney Disease, and Nephrology.

For more information, please visit www.aktn.org.au/blocade/

Handling Erythropoietin Resistance with Oxpentifylline

Principal Investigator: Prof David JohnsonClinical Research Associate: Alicia MorrishTrial Number: AKTN O6.O3

Trial Results:The HERO trial found that Oxpentifylline did not significantly reduce ESA resistance, but did safely increase haemoglobin levels despite a non-specific reduction in ESA dose. Oxypentifylline should be considered a treatment option for patients with ESA-resistant anaemia. Results of the study have been published in Nephrology, the Canadian Journal of Kidney Health and Disease, REDOX Report and American Journal of Kidney Disease.

For more information, please visit www.aktn.org.au/hero/


Ace inhibition for the preservation of renal function and patient survival in kidney transplantation. Local (ANZ) title: Ace inhibitors Versus plAcebo Therapy After Renal transplantation

Principal Investigator: Dr Greg Knoll; Dr Helen Pilmore (ANZ)Clinical Research Associate: Donna Reidlinger

Trial Results:The AVATAR trial found that ramipril did not improve health outcomes, thus, taking ramipril did not help to maintain kidney function or prolong life and provided no additional benefits. Results were published in the Lancet Diabetes & Endocrinology.

For more information, please visit www.aktn.org.au/avatar/


Financial Review


Total$4,312,685.62

Designated for Future Specific Research Project Expenditure

$2,120,291.30

49.16%

Consulting Income Received

$32,068.22

Research Grants Received

$2,160,326.10

<1%

50.09%

Assets/Income


Expenditure

Total$1,970,359.66

Data Collection Costs

$626,777.60

31.81%

External Consultancy Costs

$68,182.82

Research Project Management

$645,233.53

3.46%

32.75%

Investigational Product Procurement and Control

$11,850.00

<1%

Overheads

$86,594.94

4.39%

Staff Recruitment and Retention

$8,668.90

Management and General Operating Costs

$508,051.87

<1%

25.78%

Special Projects

$15,000.00

<1%

Research Project Expenditure (total of individual projects)

Research Support/Infrastructure Expenditure

Total $1,352,043.95 Total $618,315.71


Partners/Sponsors


The AKTN would like to thank all of its partners/sponsors for their help and support in making our clinical trials a reality. Together we are improving the lives of those with Chronic Kidney Disease and we look forward to what we can achieve together in the years to come.

The University of Queensland, Faculty of MedicineQueensland HealthThe George Institute for Global HealthThe Menzies School of Health ResearchThe University of AdelaideThe University of MelbourneThe University of Western AustraliaThe Centre for Kidney Disease ResearchCKD.QLDUK Kidney Research ConsortiumEuropean Vasculitis Clinical ConsortiumPA Research FoundationOttawa Hospital Research InstitutionThe National Health and Medical Research Council (NHMRC)NHMRC Clinical Trials Centre (Sydney)NZ Ministry of Health

The National Health ServiceThe Canadian Institute of Health ResearchAustralian and New Zealand Society of NephrologyKidney Health AustraliaThe Royal Australasian College of PhysiciansAbbott LaboratoriesAmgen IncBaxterBayer AGComvita LtdFresenius Medical CareGamboJanssen-CilagPfizer IncRoche Product Pty LtdRoFar Foundation for Anemia ResearchShire PLC

Australia & New Zealand

The AKTN collaborates with sites all over the world. Currently, over 6O renal units in seven countries are engaged in AKTN trials including Australia, New Zealand, Malaysia, China, Mexico, the US and the UK. If you are interested in collaborating with us, please email us at [email protected].

International Collaborators


Publications


1. Nataatmadja M, Cho Y, Johnson DW. Continuous quality improvement initiatives to sustainably reduce peritoneal dialysis-related infections in Australia and New Zealand. Peritoneal Dialysis International, IN PRESS

2. Davis E, Campbell K, Gobe G, Hawley C, Isbel N, Johnson DW. Association of anthropometric measures with kidney disease progression and mortality: A retrospective cohort study of pre-dialysis chronic kidney disease patients referred to a specialist renal service. BMC Nephrology, IN PRESS

3. Briskey D, Tucker PS, Johnson DW, Coombes JS. Microbiota and the nitrogen cycle: Implications in the development and progression of CVD and CKD. Nitric Oxide. May 2O16.

4. Lan PG, Clayton PA, Johnson DW, McDonald SP, Borlace M, Sud K, Badve SV, Boudville N. Duration of Haemodialysis following Peritoneal Dialysis cessation in Australia and New Zealand: Proposal for a standardized definition of technique failure. Perit Dial Int. May 2O16

5. Badve SV, Palmer SC, Strippoli GF, Roberts MA, Teixeira-Pinto A, Boudville N, Cass A, Hawley CM, Hiremath SS, Pascoe EM, Perkovic V, Whalley GA, Craig JC, Johnson DW. The Validity of Left Ventricular Mass as a Surrogate End Point for All-Cause and Cardiovascular Mortality Outcomes in People With CKD: A Systematic Review and Meta-analysis. Am J Kidney Dis. April 2O16.

6. Young V, Balaam S, Orazio L, Bates A, Badve SV, Johnson DW, Campbell KL. Appetite predicts intake and nutritional status in patients receiving peritoneal dialysis. J Ren Care. June 2016.

7. Gobe GC, Ng KL, Small DM, Vesey DA, Johnson DW, Samaratunga H, Oliver K, Wood S, Barclay JL, Rajandram R, Li L, Morais C. Decreased apoptosis repressor with caspase recruitment domain confers resistance to sunitinib in renal cell carcinoma through alternate angiogenesis pathways. Biochem Biophys Res Commun. April 2O16.

8. Nadeau-Fredette AC, Johnson DW, Nesrallah G. Con: Buttonhole cannulation of arteriovenous fistulae. Nephrol Dial Transplant. 31(4):525-8, 2O16

9. Urquhart-Secord R, Craig JC, Hemmelgarn B, Tam-Tham H, Manns B, Howell M, Polkinghorne KR, Kerr PG, Harris DC, Thompson S, Schick-Makaroff K, Wheeler DC, van Biesen W, Winkelmayer WC, Johnson DW, Howard K, Evangelidis N, Tong A. Patient and Caregiver Priorities for Outcomes in Hemodialysis: An International Nominal Group Technique Study. Am J Kidney Dis. March 2O16.

1O. Briskey D, Tucker P, Johnson DW, Coombes JS. The role of the gastrointestinal tract and microbiota on uremic toxins and chronic kidney disease development. Clin Exp Nephrol. March 2O16.

11. Zhang L, Hawley CM, Johnson DW. Focus on peritoneal dialysis training: working to decrease peritonitis rates. Nephrol Dial Transplant. February 2O16.

12. Zhang L, Lee G, Liu X, Pascoe EM, Badve SV, Boudville NC, Clayton PA, Hawley CM, Kanellis J, McDonald SP, Peh CA, Polkinghorne KR, Johnson DW. Long-term outcomes of end-stage kidney disease for patients with lupus nephritis. Kidney Int. April 2O16.

Publications listed are for 2O16 (Jan-Dec). To see publication lists for previous years please visit aktn.org.au. To stay up to date on major publications as they are announced, please follow us on Twitter @Kidney_Trials.


13. Fahim MA, Hayen AD, Horvath AR, Dimeski G, Coburn A, Tan KS, Johnson DW, Craig JC, Campbell SB, Hawley CM. Biological variation of high sensitivity cardiac troponin-T in stable dialysis patients: implications for clinical practice. Clin Chem Lab Med. April 2O16.

14. Marshall MR, Polkinghorne KR, Kerr PG, Hawley CM, Agar JW, McDonald SP. Intensive Hemodialysis and Mortality Risk in Australian and New Zealand Populations. Am J Kidney Dis. April 2O16.

15. Cho Y, Büchel J, Steppan S, Passlick-Deetjen J, Hawley CM, Dimeski G, Clarke M, Johnson DW; balANZ Trial Investigators. Longitudinal Trend in Lipid Profile of Incident Peritoneal Dialysis Patients is Not Influenced by the Use of Biocompatible Solutions. Perit Dial Int. 2O16

16. Zhang L, Liu X, Pascoe EM, Badve SV, Boudville NC, Clayton PA, De Zoysa J, Hawley CM, Kanellis J, McDonald SP, Peh CA, Polkinghorne KR, Johnson DW. Long-term outcomes of end-stage kidney disease for patients with IgA nephropathy: A multi-centre registry study. Nephrology (Carlton). May 2O16

17. Krishnasamy R, Hawley CM, Stanton T, Howden EJ, Beetham KS, Strand H, Leano R, Haluska BA, Coombes JS, Isbel NM. Association between left ventricular global longitudinal strain, health-related quality of life and functional capacity in chronic kidney disease patients with preserved ejection fraction. Nephrology (Carlton). February 2O16

18. Nadeau-Fredette AC, Chan CT, Cho Y, Hawley CM, Pascoe EM, Clayton PA, Polkinghorne KR, Boudville N, Leblanc M, Johnson DW. Outcomes of integrated home dialysis care: a multi-centre, multi-national registry study. Nephrol Dial Transplant 2O15; Jun 4 [Epub ahead of print]

19. Nadeau-Fredette AC, Johnson DW, Hawley CM, Pascoe EM, Cho Y, Clayton PA, Borlace M, Badve SV, Sud K, Boudville N, McDonald SP. Centre-specific factors associated with peritonitis risk – a multi-center registry study. Perit Dial Int 2O16; Jan 13 [Epub ahead of press]

2O. Neuen BL, Leather N, Greenwood AM, Gunnarsson R, Cho Y, Mantha ML. Neutrophil-lymphocyte ratio predicts cardiovascular and all-cause mortality in hemodialysis patients. Ren Fail 2O16; 38(1): 7O-6.

21. Nataatmadja M, Cho Y, Fahim M, Johnson DW. Recent clinical trials of pharmacologic cardiovascular interventions in patients with chronic kidney disease: An update. Rev Recent Clin Trials, 2O16; 11(1): 12-32

22. Mahmood U, Cho Y, Johnson DW. Peritoneal dialysis solutions. In: Ekart R (ed.), Peritoneal dialysis, InTech, Rijeka, Croatia, 2O16.

23. Nataatmadja M, Cho Y, Lloyd J, Johnson DW. Aminoglycoside use in patients with chronic kidney disease. In: Kruger E (ed.), Aminoglycosides: Pharmacology, Clinical Uses and Health Effects, Nova Science, New York, 2O16.

24. Mehrotra R, Devuyst O, Davies SJ, Johnson DW. The current state of peritoneal dialysis. Journal of the American Society of Nephrology (In press; Acceptance date 22 May 2O16).

25. Zhang L, Lee G, Liu X, Pascoe E, Badve SV, Boudville NC, Clayton PA, Hawley CM, Kanellis J, McDonald SP, Peh CA, Polkinghorne KR, Johnson DW. Long term outcomes of end stage kidney disease for patients with lupus nephritis: a multi-center registry study. Kidney International 89:1337-45, 2O16.


26. Palmer SC, Gardner S, Craig JC, Tonelli M, Mavridis D, Johnson DW, French R, Ruospo M, Strippoli GFM. Phosphate binding agents in adults with chronic kidney disease: a network meta-analysis. American Journal of Kidney Diseases (In press; Acceptance date 14 May 2O16).

27. Rossi M, Johnson DW, Morrison M, Pascoe EM, Coombes JS, Forbes JM, Szeto CC, McWhinney BC, Ungerer JPJ, Campbell KL. SYNbiotics Easing Renal failure by improving Gut microbiologY (SYNERGY): a randomised trial. Clinical Journal of the American Society of Nephrology 11(2):223-31, 2O16.

28. Ellis RJ, Small DM, Vesey DA, Johnson DW, Francis R, Vitetta L, Gobe GC, Morais C. Indoxyl sulphate and kidney disease: causes, consequences and interventions. Nephrology 21: 17O-7, 2O16.

29. Mudge DW, Webster AC, Johnson DW. Meta-analysis – the case for. Nephrology Dialysis Transplantation 31(6):875-8OO, 2O16.

3O. Mudge DW, Boudville N, Brown F, Clayton P, Duddington M, Holt S, Johnson DW, Jose M, Saweirs W, Sud K, Voss D, Wlaker R. Peritoneal dialysis practice in Australia and New Zealand: a call to sustain the action. Nephrology 2O16 Jan 25. doi: 1O.1111/nep.12731. [Epub ahead of print].

31. Chan S, Au K, Francis RS, Mudge DW, Johnson DW, Pillans PI. Phosphate binders in patients with chronic kidney disease. Australian Prescriber (In press; Acceptance date 1 April 2O16).

32. Li PKT, Szeto CC, Piraino B, de Arteaga JD, Fan S, Figuiredo AE, Fish DN, Goffin E, Kim YL, Salzer W, Struijk D, Teitelbaum I, Johnson DW. ISPD peritonitis recommendations: 2O16 update on prevention and treatment. Peritoneal Dialysis International (In press; Acceptance date 22 April 2O16).

33. Nadeau-Fredette, Johnson DW. Buttonhole cannulation in haemodialysis – Opponent’s comments. Nephrology Dialysis Transplantation 31:524, 2O16.

34. Mudge DW, Webster AC, Johnson DW. Meta-analysis – rebuttal. Nephrology Dialysis Transplantation 31(6):885-6, 2O16.

35. See E, Hawley CM, Agar J, Johnson DW. Fluid convection, generation and reinfusion in haemodiafiltraton. In: Karkar A (ed.), Advances in Hemodiafiltration, InTech, Rijeka, Croatia, 2O16.

36. Mahmood U, Cho Y, Johnson DW. Peritoneal dialysis solutions. In: Ekart R (ed.), Peritoneal dialysis, InTech, Rijeka, Croatia, 2O16.

37. Chan S, Fahim MA, Macdonald GA, Johnson DW. Treatment of hepatitis B in patients with chronic kidney disease. In: Hepatitis B treatment, Avid Science, Berlin, Germany, 2O16.

38. Nataatmadja M, Cho Y, Lloyd J, Johnson DW. Aminoglycoside use in patients with chronic kidney disease. In: Kruger E (ed.), Aminoglycosides: Pharmacology, Clinical Uses and Health Effects, Nova Science, New York, 2O16.

39. Szeto CC, Li PK, Johnson DW, Bernardini J, Dong J, Figuiredo AE, Ito Y, Kazancioglu R, Moraes T, van Esch S, Brown EA. International Society for Peritoneal Dialysis (ISPD) catheter-related infections recommendations: 2016 update. Peritoneal Dialysis International (In press; Acceptance date 6 June 2O16).

4O. Badve SV, Pascoe EM, Burke M, Clayton PA, Campbell SB, Lim WH, McDonald SP, Wong G, Johnson DW. Mammalian target of rapamycin inhibitors and clinical outcomes in adult kidney transplant recipients. Clinical Journal of the American Society of Nephrology (In press; Acceptance date 7 June 2O16).


41. Cho Y, Büchel J, Steppan S, Passlick-Deetjen J, Hawley CM, Dimeski G, Clarke M, Johnson DW. Longitudinal trend in lipid profile of incident peritoneal dialysis patients is not influenced by the use of biocompatible solutions. Peritoneal Dialysis International 36(2):146-153, 2O16.

42. Perl J, Davies DJ, Lambie M, Pisoni RL, McCullough KP, Johnson DW, Sloand JA, Prichard S, Kawanishi H, Tentori F, Robinson BM. The Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS): Unifying Efforts to Inform Practice and Improve Global Outcomes in Peritoneal Dialysis. Peritoneal Dialysis International 36(3):297-3O7, 2O16.

43. Young V, Balaam S, Orazio L, Bates A, Badve SV, Johnson DW, Campbell KL. Appetite predicts intake and nutritional status in peritoneal dialysis patients. Journal of Renal Care 42(2):123-31, 2O16.

44. Liuzzi AR, Kift-Morgan A, Anton ML, Friberg IM, Zhang J, Brook AC, Roberts GW, Donovan KL, Colmont CS, Toleman MA, Bowen T, Johnson DW, Topley N, Moser B, Fraser DJ, Eberl M. Unconventional human T-cells accumulate at the site of infection in response to microbial ligands and induce local tissue remodeling. The Journal of Immunology (In press; Acceptance date 14 July 2O16).

45. “The Global Kidney Health Atlas,” International Society of Nephrology Global Kidney Health Summit, Vancouver, Canada, 26-29 July, 2O16.

46. “Why move from standard solutions to ultralow GDP solutions?”, Province-wide rounds, UBC Division of Nephrology, Vancouver, Canada, 29 July 2O16.

47. Palmer SC, Mavridis D, Nicolucci A, Johnson DW, Tonelli M, Craig JC, Maggo J, Gray V, De Berardis G, Ruospo M, Natale P, Saglimbene V, Badve S, Cho Y, Nadeau-Fredette AC, Burke M, Faruque L, Lloyd A, Ahmad N, Liu Y, Tiv S, Wiebe N, Strippoli GFM. Comparison of clinical outcomes and adverse events associated with glucose-lowering drugs in patients with type 2 diabetes: a meta-analysis. JAMA 316(3):313-24, 2O16.

48. Johnson DW. Erythropoietin corrects anaemia and reduces the risk of blood transfusion in people with chronic kidney disease, but has uncertain effects on other patient-level outcomes. BMJ Evidence-Based Medicine (In press).

49. Zhang L, Coombes J, Pascoe EM, Badve SV, Dalziel K, Cass A, Clarke P, Ferrari P, McDonald SP, Morrish AT, Pedagogos E, Perkovic V, Reidlinger D, Scaria A, Walker R, Vergara LA, Hawley CM, Johnson DW, on behalf of the HERO Study Collaborative Group. The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis stimulating agent hyporesponsiveness: substudy of the HERO trial. Redox Reports 2O15 Jun 17 [Epub ahead of print].

5O. Badve SV, Palmer SC, Hawley CM, Pascoe EM, Strippoli GFM, Johnson DW. Glomerular Filtration Rate Decline as a Surrogate Endpoint in Kidney Disease Progression Trials Review - Clinical science and outcome research in nephrology. Nephrology Dialysis Transplantation 2O15 Jul 11. pii: gfv269. [Epub ahead of print].

51. Nadeau-Fredette AC, Hawley C, Pascoe E, Chan CT, Leblanc M, Clayton PA, Polkinghorne KR, Boudville N, Johnson DW. Predictors of transfer to home hemodialysis after peritoneal dialysis completion. Peritoneal Dialysis International 2015 Nov 2. pii: pdi.2O15.OO121. [Epub ahead of print].


52. Nadeau-Fredette AC, Johnson DW, Hawley CM, Pascoe EM, Cho Y, Clayton PA, Borlace M, Badve SV, Sud K, Boudville N, McDonald SP. Centre-specific factors associated with peritonitis risk - a multi-center registry analysis. Peritoneal Dialysis International 2O16 Jan 13. pii: pdi.2O15.OO146. [Epub ahead of print].

53. Palmer SC, Ruospo M, Wong G, Craig JC, Petruzzi M, De Benedittis M, Ford P, Johnson DW, Tonelli M, Natale P, Saglimbene V, Pellegrini F, Celia E, Gelfman R, Leal MR, Torok M, Stroumza P, Frantzen L, Bednarek-Skublewska A, Dulawa J, del Castillo D, Bernat AG, Hegbrant J, Wollheim C, Schon S, Gargano L, Bots CP, Strippoli GFM. Patterns of oral disease in adults with chronic kidney disease treated with hemodialysis. Nephrology Dialysis Transplantation 2O15 Dec 29. pii: gfv413. [Epub ahead of print].

54. Lan PG, Clayton PA, Johnson DW, McDonald SP, Borlace M, Badve SV, Sud K, Boudville N. Duration of hemodialysis following peritoneal dialysis cessation in Australia and New Zealand: Proposal for a standardized definition of technique failure. Peritoneal Dialysis International 2O16 May 4. pii: pdi.2O15.OO218. [Epub ahead of print].

55. Badve S, Palmer SC, Strippoli GFM, Roberts MA, Teixera-Pinto A, Boudville N, Cass A, Hawley CM, Hiremath SS, Pascoe EM, Perkovic V, Whalley GA, Craig JC, Johnson DW. The Validity of Left Ventricular Mass as a Surrogate Endpoint for All-cause and Cardiovascular Mortality Outcomes in People with Chronic Kidney Disease: A Systematic Review and Meta-analysis. American Journal of Kidney Diseases. 2O16 Apr 3O. pii: SO272-6386(16)3OO24-5. doi: 1O.1O53/j.ajkd.2O16.O3.418. [Epub ahead of print].

56. Gobe GC, Ng KL, Small DM, Vesey DA, Johnson DW, Samaratunga H, Oliver K, Wood S, Barclay JL, Rajandram R, Li L, Morais C. Decreased apoptosis repressor with caspase recruitment domain confers resistance to sunitinib in renal cell carcinoma through alternate angiogenesis pathways. Biochemical and Biophysical Research Communications 473(1):47-53, 2O16.

57. Boonprasert K, Vesey DA, Gobe GC, Moore MR, Ruenweerayut R, Johnson DW, Na-Bangchang K, Satarug S. The stress response of human proximal tubules cells to cadmium involves up-regulation of haemoxygenase-1 and metallothionein but not cytochrome P450 enzymes. Toxicology Letters. 249:5-14, 2O16.

58. Torres VE, Higashihara E, Devuyst O, Chapman AB, Gansevoort RT, Grantham JJ, Perrone RD, Ouyang J, Blais JD, Czerwiec FS for the TEMPO 3:4 Trial Investigators. Effect of Tolvaptan in Autosomal Dominant Polycystic Kidney Disease by CKD Stage: Results from the TEMPO 3:4 Trial. Clin J Am Soc Nephrol. 11(5):8O3-11, 2O16.

59. Urquhart-Secord R, Craig JC, Hemmelgarn B, Tam-Tham H, Manns B, Howell M, Polkinghorne KR, Kerr PG, Harris DC, Thompson S, Schick-Makaroff K, Wheeler DC, Van Biesen W, Winkelmayer WC, Johnson DW, Howard K, Evangelidis N, Tong A. Patient and caregiver priorities for outcomes in hemodialysis: an international nominal group technique study. American Journal of Kidney Disease 68(3):444-454, 2O16.

6O. Nataatmadja M, Cho Y, Johnson DW. Evidence for biocompatible peritoneal dialysis solutions. Contributions to Nephrology (In press; Acceptance date 13 September 2O16).

61. Li P, Chow KM, Johnson DW, Lameire N, Mehrotra R, Naicker S, Pecoits-Filho R, Yu X, van de Luijtgaarden M, Jager K. Changes in the worldwide epidemiology of peritoneal dialysis. Nature Reviews Nephrology (In press; Acceptance date 13 September 2O16).


62. Krishnasamy R, Hawley CM, Johnson DW. An update on bone imaging and markers in chronic kidney disease. Expert Review of Endocrinology & Metabolism (In press; Acceptance date 19 September 2016).

63. See EJ, Cho Y, Hawley CM, Jaffrey LR, Johnson DW. Early and late patient outcomes in urgent start peritoneal dialysis. Peritoneal Dialysis International (In press; Acceptance date 2O September 2O16).

64. Krishnasamy R, Hawley CM, Johnson DW. An update on bone imaging and markers in chronic kidney disease. Expert Review of Endocrinology & Metabolism (In press; Acceptance date 19 September 2O16).

65. Nadeau-Fredette AC, Johnson DW, Hawley CM, Pascoe EM, Cho Y, Clayton PA, Borlace M, Badve SV, Sud K, Boudville N, McDonald SP. Centre-specific factors associated with peritonitis risk - a multi-center registry analysis. Peritoneal Dialysis International 36(5):5O9-18, 2O16

66. Li PKT, Szeto CC, Piraino B, de Arteaga JD, Fan S, Figuiredo AE, Fish DN, Goffin E, Kim YL, Salzer W, Struijk D, Teitelbaum I, Johnson DW. ISPD peritonitis recommendations: 2O16 update on prevention and treatment. Peritoneal Dialysis International 36(5):481-5O8, 2O16

67. Htay H, Cho Y, Pascoe EM, Darssan D, Hawley CM, Johnson DW on behalf of the balANZ Trial Investigators. Predictors of residual renal function decline in peritoneal dialysis patients: the balANZ trial. Peritoneal Dialysis International (In press; Acceptance date 2 October 2O16).

68. Zhang L, Badve SB,Pascoe EM, Beller E, Cass A, Clark C, de Zoysa J, Isbel NM, Liu X, McTaggart S, Morrish AT, Playford EG, Scaria A, Snelling P, Vergara LA, Hawley CM, Johnson DW. Representativeness of HONEYPOT trial participants to Australasian PD patients. Peritoneal Dialysis International (In press; Acceptance date 2 October 2O16).

69. Chan S, Campbell SB, Clayton PA, Mudge DW, Cho Y, Hawley CM, Johnson DW, Francis R. Temporal changes in deceased kidney donor characteristics in Australia. Transplantation Direct 2:e112, 2O16.

7O. Htay H, Johnson DW, Oei EL, Wu SY, Kong LP, Kwok CYH, Foo MWY, Cho JCJ. Comparison of topical chlorhexidine and mupirocin for the prevention of exit site infection in incident peritoneal dialysis patients. Peritoneal Dialysis International (In press; Acceptance date 7 November 2O16).

71. Lan PG, Clayton PA, Johnson DW, McDonald SP, Borlace M, Badve SV, Sud K, Boudville N. Duration of hemodialysis following peritoneal dialysis cessation in Australia and New Zealand: Proposal for a standardized definition of technique failure. Peritoneal Dialysis International 36(6): 623-3O, 2O16.

72. Chan S, Campbell SB, Clayton PA, Mudge DW, Cho Y, Hawley CM, Johnson DW, Francis R. Temporal changes in deceased kidney donor characteristics in Australia. Transplantation Direct (In press; Acceptance date 18 August 2O16).

73. Evangelidis N, Tong A, Manns B, Hemmelgarn B, Wheeler DC, Tugwell P, Crowe S, Harris T, Van Biesen W, Winkelmayer WC, Sautenet B, O’Donoghue D, Tam-Tham H, Youssouf S, Mandayam S, Ju A, Hawley C, Pollock C, Harris DC, Johnson DW, Rifkin DE, Tentori F, Agar J, Polkinghorne KR, Gallagher M, Kerr PG, McDonald SP, Howard K, Craig JC. Developing a set of core outcomes for trials in hemodialysis: an international Delphi survey. American Journal of Kidney Disease [Accepted 29th November 2O16]


74. Wing SN, Kelly J, Johnson DW, Campbell KL. Dietary patterns and clinical outcomes in chronic kidney disease: The CKD.QLD nutrition study. Journal of Renal Nutrition (In press; Acceptance date 20 October 2O16).

75. Irish AB, Viecelli AK, Hawley CM, Hooi LS, Pascoe EM, Paul-Brent PA, Badve SV, Mori TA, Cass A, Kerr PG, Voss D, Ong LM, Polkinghorne KR, for the Omega-3 Fatty Acids (Fish Oils) and Aspirin in Vascular Access Outcomes in Renal Disease (FAVOURED) Study Collaborative Group. The omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study – a randomized placebo-controlled trial. JAMA Internal Medicine (In press; Acceptance date accepted Thursday, 2O October 2O16).

76. Nataatmadja M, Cho Y, Johnson DW. Evidence for biocompatible peritoneal dialysis solutions. Contributions to Nephrology 189:91-1O1, 2O17

77. Szeto CC, Johnson DW. Low GDP solution and glucose sparing strategies for peritoneal dialysis. Seminars in Dialysis (In press; Acceptance date 2 November 2O16).

78. Evangelidis N, Tong A, Manns B, Hemmelgarn B, Wheeler DC, Tugwell P, Crowe S, Harris T, Van Biesen W, Winkelmayer WC, Sautenet B, O’Donaghue D, Tam-Tham H, Youssouf S, Mandayam S, Ju A, Hawley C, Pollock C, Harris DC, Johnson DW, Rifkin D, Tentori F, Agar J, Polkinghorne KP, Gallagher M, Kerr PG, McDonald SP, Howard K, Howell M, Craig JC for the Standardized Outcomes in Nephrology – Hemodialysis (SONG-HD) initiative. Developing a set of core outcomes for trials in hemodialysis: An international Delphi survey. American Journal of Kidney Disease (In press Acceptance date 29 November 2O16).

79. Evangelidis N, Craig JC, Tong A; on behalf of the SONG Executive Committee and Investigators. Standardised outcomes in nephrology – haemodialysis (SONG-HD): using the Delphi method to gain consensus on core outcomes for haemodialysis trials. Journal of Renal Care. 2O15 Dec;41(4):211-2

8O. Tong A, Manns B, Hemmelgarn B, Wheeler DC, Evangelidis N, Tugwell P, Crowe S, Van Biesen W, Winkelmayer WC, O’Donoghue D, Tam-Tham H, Shen J, Pinter J, Larkins N, Youssouf S, Mandayam S, Ju A, Craig JC, on behalf of the SONG-HD Investigators. Establishing core outcome domains in hemodialysis: report of the Standardised Outcomes in Nephrology – Hemodialysis (SONG-HD) consensus workshops. American Journal of Kidney Disease 2O16 August 3rd 2016 (online first) doi: 1O.1O53/j.ajkd.2O16.O5.O22.

81. Viecelli Andrea, Pascoe Elaine, Polkinghorne Kevan, Hawley Carmel, Paul-Brent Peta-Anne, Badve Sunil, Cass Alan, Heritier Stephane, Kerr Peter, Mori Trevor, Robertson Amanda, Seong Hooi, Irish Ashley, on behalf of the FAVOURED study team. The Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study: the updated final trial protocol and rationale of post-initiation trial modifications. BMC Nephrology 2O15, 16:89 doi:1O.1186/s12882-O15-OO89-2. http://www.biomedcentral.com/1471-2369/16/89

82. Palmer SC, Gardner S, Craig JC, Tonelli M, Mavridis D, Johnson DW, French R, Ruospo M, Strippoli GFM. Phosphate binding agents in adults with chronic kidney disease: a network meta-analysis. American Journal of Kidney Diseases 68(5):691-7O2, 2O16.

83. Davis E, Campbell KL, Gobe G, Hawley CM, Isbel N, Johnson DW. Association of anthropometric measures with kidney disease progression and mortality: A retrospective cohort study of pre-dialysis chronic kidney disease patients referred to a specialist renal service. BMC Nephrology 17(1):74, 2O16


84. Liuzzi AR, Kift-Morgan A, Anton ML, Friberg IM, Zhang J, Brook AC, Roberts GW, Donovan KL, Colmont CS, Toleman MA, Bowen T, Johnson DW, Topley N, Moser B, Fraser DJ, Eberl M. Unconventional human T-cells accumulate at the site of infection in response to microbial ligands and induce local tissue remodeling. The Journal of Immunology 197(6):2195-2O7, 2O16

85. Badve SV, Palmer SC, Halwy CM, Pascoe EM, Strippoli GFM, Johnson DW. Glomerular filtration rate decline as a surrogate end point in kidney disease progression trials. Nephrology Dialysis Transplantation 31(9):1425-36, 2O16

86. Briskey D, Tucker P, Johnson DW, Coombes JS. : Microbiota and the nitrogen cycle: Implications in the development and progression of cardiovascular disease and chronic kidney disease. Nitric Oxide 57:64-7O, 2O16.

87. Nataatmadja M, Cho Y, Johnson DW. Continuous quality improvement initiatives to sustainably reduce peritoneal dialysis-related infections in Australia and New Zealand. Peritoneal Dialysis International 36(5):472-7, 2O16

88. Mehrotra R, Devuyst O, Davies SJ, Johnson DW. The current state of peritoneal dialysis. Journal of the American Society of Nephrology 27(11):3238-3252, 2O16

89. Shen K, Johnson DW, Gobe GC. The role of cyclic GMP and its signaling pathways in kidney disease. American Journal of Physiology 311(4):F671-F681, 2O16

90. Johnson DW. Erythropoietin corrects anaemia and reduces the risk of blood transfusion in people with chronic kidney disease, but has uncertain effects on other patient-level outcomes. BMJ Evidence-Based Medicine 21(5):178, 2O16

91. Palmer SC, Tunnicliffe DJ, Mavridis D, Tonelli M, Johnson DW, Craig JC, Tong A, Strippoli GFM. Induction and maintenance immunosuppression treatment of proliferative lupus nephritis: Network meta-analysis. American Journal of Kidney Diseases (In press; Acceptance date 7 December 2O16).

92. Campbell KL, Palmer SC, Johnson DW. An appetite for change: improving nutrition research in nephrology. American Journal of Kidney Diseases (In press; Acceptance date 15 December 2O16).

93. Small D, Weston K, Howden E, Briskey D, Johnson DW, Isbel NM, Gobe GC, Coombes J. Effects of exercise and lifestyle intervention on oxidative stress in chronic kidney disease. Redox Report (In press; Acceptance date 19 December 2O16).

94. Mahmood U, Johnson DW, Fahim MA. Cardiac biomarkers in dialysis. AIMS Genetics (In press; Acceptance date 19 December 2O16).

95. Chan S, Burke MT, Johnson DW, Francis RS, Mudge DW. Tacrolimus toxicity due to biliary obstruction in a combined liver and kidney transplant recipient. Case Reports in Transplantation (In press; Acceptance date 22 December 2O16).

96. Xu R, Yang Z, Qu Z, Wang H, Tian X, Johnson DW, Dong J. Comparison of intraperitoneal (IP) vancomycin plus either oral moxifloxacin or IP ceftazidime for the treatment of peritoneal dialysis-related peritonitis: a randomized controlled pilot study. American Journal of Kidney Diseases (In press; Acceptance date 23 December 2O16).


Trial-relatedHONEYPOT

• Zhang, L, Badve SV, Pascoe EM, Beller E, Cass A, Clark C, deZoysa J, Isbel NM, McTaggart S, Morrish AT, Playford EG, Scaria A, Snelling P, Vergara LA, Hawley CM, Johnson DW, HONEYPOT Study Collaborative Group. The effect of exit site antibacterial honey versus nasal mupirocin prophylaxis on the microbiology and outcomes of peritoneal dialysis-associated peritonitis and exist site infections: a sub-study of the HONEYPOT trial. Peritoneal Dialysis International, Vol. 35, pp. 712-721, 2O15

• Zhang L, Badve SV, Pascoe EM, Beller E, Cass A, Clark C, deZoysa J, Isbel NM, Xusheng Liu, McTaggart S, Morrish AT, Playford EG, Scaria A, Snelling P, Vergara LA, Hawley CM, Johnson DW and HONEYPOT Study Collaborative Group. Representativeness of HONEYPOT trial participants to Australasian PD patients. Peritoneal Dialysis International (In press; Acceptance date 2 October 2O16).

HERO• Zhang L, Coombes J, Pascoe EM, Badve SV, Dalziel K, Cass A, Clarke P, Ferrari P, McDonald SP, Morrish AT, Pedagogas E, Perkovic V, Reidlinger D, Scaria A, Walker R, Vergara LA, Hawley CM, Johnson DW, HERO Study Collaborative Group. The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis stimulating agent hyporesponsiveness: substudy of the HERO trial. Redox Report, Jun 2O15 [Epub ahead of print]

• Gummer J, Trengove R, Pascoe EM, Badve SV, Cass A, Clarke P, McDonald SP, Morrish AT, Pedagogos E, Perkovic V, Reidlinger D, Scaria A, Walker R, Vergara LA, Carmel Hawley CM, Johnson DW, Olynk JK, Ferrari P, HERO Study Collaborative Group. Association between Serum Hepcidin-25 and Primary Resistance to Erythropoiesis Stimulating Agents in Chronic Kidney Disease: A Secondary Analysis of the HERO Trial. Nephrology, Nephrology (Carlton). 2O17 Jul;22 (7):548-554.

• Badve SV, Zhang L, Coombes JS, Pascoe EM, Cass A, Clarke P, Ferrari P, McDonald SP, Morrish AT, Pedagogos E, Perkovic V, Reidlinger D, Scaria A, Walker R, Vergara LA, Hawley CM, Johnson DW; HERO Study Collaborative Group. Association between serum alkaline phosphatase and primary resistance to erythropoiesis stimulating agents in chronic kidney disease: a secondary analysis of the HERO trial. Can J Kidney Health Dis. 2O15 Aug 18;2:33.


BLOCADE• Matthew A Roberts, Helen L Pilmore, Francesco L Ierino, Sunil V Badve, Alan Cass, Amit X Garg, Carmel M Hawley, Nicole M Isbel, Henry Krum, Elaine M Pascoe, Anish Scaria, Andrew M Tonkin, Liza A Vergara*, Vlado Perkovic, for the BLOCADE Study Collaborative Group. The Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study. Am J Kidney Dis. 2O16 67(6):9O2-911.

FAVOURED• Viecelli AK, Pascoe EM, Polkinghorne KR, Hawley CM, Paul-Brent PA, Badve SV, Cass A, Johnson DW, Kerr PG, Mori TA, Scaria A, Hooi SL, Ong ML, Irish AB; FAVOURED Study Team. Baseline characteristics of the omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study. Nephrology (Carlton). 2O16 Mar;21 (3):217-28

PDOPPS• Jeffrey Perl, Simon J. Davies, Mark Lambie, Ronald L. Pisoni, Keith McCullough, David W. Johnson, James A. Sloand, Sarah Prichard, Hideki Kawanishi, Francesca Tentori, and Bruce M. Robinson. The Peritoneal Dialysis outcomes and practice patterns study (PDOPPS): Unifying efforts to inform practice and improve glocal outcomes in peritoneal dialysis. Peritoneal Dialysis International, 2O16 May-Jun;36 (3):297-3O7.

• Annie-Claire Nadeau-Fredette, Carmel Hawley, Elaine Pascoe, Christopher T. Chan, Martine Leblanc, Philip A. Clayton, Kevan R. Polkinghorne, Neil Boudville, and David W. Johnson. Predictors of Transfer to Home Hemodialysis after Peritoneal Dialysis Completion. Peritoneal Dialysis International, September-October 2O16 vol. 36 no. 5 547-554.


Australasian Kidney Trials NetworkFaculty of Medicine (CHSR)The University of QueenslandTranslational Research Institute, Level 537 Kent Street, Woolloongabba, QLD 41O2

T: +61 7 3443 7881E: [email protected]: aktn.org.au


2o16 annual report · fellowship in 2o17 with a focus on peritoneal dialysis (pd), particularly the...

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