PREDNOS 2 PREDNOS 2 PREDNOS 2 NewsletterNewsletterNewsletter Issue 23, April 2019

Full Title: Short course daily prednisolone therapy at the time of upper respiratory tract infection (URTI) in children with relapsing

steroid sensitive nephrotic syndrome (SSNS)

Short Title: The PREDNOS 2 Study

Recent Recruiters

We would like to thank Dr N

West at Great Western Hospital,

Dr H Cottis at Royal Devon &

Exeter Hospital, Dr N Elhadi at

West Middlesex University

Hospital, Dr B Ulbrich at

Addenbrooke’s Hospital, Dr C

Jones at Alder Hey Hospital, Dr

O Cuthell at Derriford Hospital,

Dr D Bockenhaur at Great

Ormond Street Hospital, Dr M

Javed at Manor Hospital,

Walsall, Dr B Reynolds at Royal

Hospital for Sick Children,

Edinburgh, Dr B Padmakumar at

Royal Oldham Hospital, Dr S

Meyrick at Hereford County

Hospital, Dr K Cesar at West

Suffolk Hospital and all of their

teams, for randomising patients

in December 2018 and January

2019.

Welcome to the 23rd Issue of the PREDNOS 2 Newsletter!

Since PREDNOS 2 opened on 22nd February

2013, 365 patients have been recruited into

the study to date and 122 centres have full

approvals in place. We would like to contin-

ue passing on our thanks to all of the PRED-

NOS 2 collaborators for your ongoing hard

work and support. Recruitment dropped in

December with 3 patients randomised,

however we had an excellent final month in

January with 10 patients randomised!

PREDNOS 2 Recruitment Com-

plete & Randomisation Closed!

Many thanks to all of you for the huge amount of effort you’ve put into PREDNOS 2 so far – the trial is now closed to randomi-sation, with a final total of 365 patients ran-domised! Our focus now needs to move from recruitment, to data quality. We need to do our utmost to provide data of the highest quality possible, to ensure that the

results of this incredibly important study are robust and reliable!

PREDNOS 2 Site Staff Teleconfer-ences

The PREDNOS 2 trial team will be hosting

teleconferences for staff working on the tri-

al. These teleconferences can be used as an

opportunity to discuss any issues you may

have in PREDNOS 2 with your colleagues

around the country, and also provide the

chance to discuss best practice.

The teleconferences are informal and are

for any member of staff working on PRED-

NOS 2 - doctors, nurses, administrative staff,

support staff - all are welcome!

If you are interested in joining one

of these teleconferences please

email the PREDNOS 2 inbox PRED-

NOS2@trials.bham.ac.uk and we

will try to arrange a date.

GDPR Addendum

For some patients in the trial, we have not yet been provided with confirmations that the updated information has been given out following the new GDPR regulations coming into effect last May. Please see the below instructions on how to do this (if not done already).

1. Participants currently in follow-up they should have the relevant addendum given to them at their next clinic appointment (whether this is a trial related appointment or not). This should be documented in the patient’s medical notes.

2. Where possible, any participants that have completed follow-up should have the

relevant addendum given to them at their next clinic appointment alongside their Parent/

Patient Information Sheet. This should be documented in the patient’s medical notes.

PREDNOS 2 NewsletterPREDNOS 2 NewsletterPREDNOS 2 Newsletter Issue 23, April 2019

Easter Arrangements 2019 Please note that the PREDNOS 2 study office at BCTU will be closed from 5pm Thursday 18th April 2019 until 9am

Thursday 25th April 2019. The online Data Entry service will still be available during this time.

Pharmacy Easter Arrangements 2019 Birmingham Children’s Hospital Pharmacy will only be able to send out PREDNOS 2 study medication on the

following days: Full service as normal up until Thursday 18th April 2019 and full service will resume on Tuesday 23rd April 2019. Please note Pharmacy closed days are Friday 19th April 2019 and Monday 22nd April 2019.

Study Medication Compliance Parents/participants should be reminded to bring all pots of study medication (unopened, opened and empty) to

each 3-monthly study assessment visit in order for compliance to be assessed.

Easter 2019 SAE Reporting Please report any SAEs to Dr Martin Christian by email during this period: Martin.Christian@nuh.nhs.uk

Full Title: Short course daily prednisolone therapy at the time of upper respiratory tract infection (URTI) in children with relapsing

steroid sensitive nephrotic syndrome (SSNS)

Short Title: The PREDNOS 2 Study

PREDNOS 2 Centres & Graph

A list of all of the centres involved in PREDNOS 2 can be

seen on the following page on the PREDNOS 2 website,

www.birmingham.ac.uk/prednos2/recruitment. For a

graph of recruitment into the study , please also see the

same page as above, then click on “A graph of the study

recruitment so far is available here.” link.

PREDNOS 2 Recruitment Map

We are pleased to

announce we now have

122 centres fully

approved in PREDNOS2,

with the assistance of the

NIHR Clinical Research

Network (CRN): Children.

Please see recruitment by

NIHR CRN: Children

Region on the left:

PREDNOS 2 NewsletterPREDNOS 2 NewsletterPREDNOS 2 Newsletter Issue 23, April 2019

URTI Reporting Issues

The number of participants completing the 12

month follow-up without experiencing at least

one URTI still remains higher than originally

expected. Please could we remind sites of the

following to ensure all URTIs are reported:

At each assessment visit please ensure the

family understand the criteria for an URTI

and that study medication should be

commenced each and every time the

participant meets the criteria for an URTI

during the 12 month follow-up period.

Parents/participants should be reminded to

contact their local site or the PREDNOS 2

hotline (07896 818647) before or within 24

hours of commencing study medication.

Ensure the correct information is given to

the parents/participants on how to

administer study medication if the criteria

for an URTI are met. Details on correct

dosing of study drug can be found in the

Protocol version 3.0 Section 4.8.

Finally, if you have any questions at all

regarding treatment of URTIs within

PREDNOS 2, the trial team contact details

are all in the column on the right and we’re

happy to help!

Full Title: Short course daily prednisolone therapy at the time of upper respiratory tract infection (URTI) in children with relapsing

steroid sensitive nephrotic syndrome (SSNS)

Short Title: The PREDNOS 2 Study

PREDNOS 2 Contacts

PREDNOS 2 Chief Investigator: Dr Martin Christian, Nottingham Children’s Hospital, Martin.Christian@nuh.nhs.uk. PREDNOS 2 Hotline: For urgent clinical queries, Tel: 07896 818647 PREDNOS 2 Website: www.birmingham.ac.uk/PREDNOS2 PREDNOS 2 FAX: 0121 415 9135 PREDNOS 2 Study Team Tele-phone: 0121 415 9131 PREDNOS 2 Email: PREDNOS2@trials.bham.ac.uk Telephone Randomisation: Available 9am-5pm Monday to Friday: 0800 953 0274 Online Randomisation: Available 24hrs: www.trials.bham.ac.uk/PREDNOS2 POSTAL ADDRESS: PREDNOS 2 Study Office, Birmingham Clinical Trials Unit (BCTU) Institute of Applied Health Re-search College of Medical and Dental Sciences Public Health Building University of Birmingham Edgbaston Birmingham B15 2TT

Aim: To evaluate the effectiveness of a six day course of daily prednisolone therapy at the time of upper respiratory tract infection (URTI) in reducing the development of subsequent nephrotic syndrome relapse in children with relapsing SSNS. Design: Phase III double blind randomised controlled trial (RCT). Population: Children with relapsing steroid sensitive nephrotic syndrome (SSNS) (≥2 relapses in preceding 12 months). Study Co-Sponsors: University of Birming-ham and Manchester University NHS Foun-dation Trust, (Ref: RG_12-188). Funding: National Institute for Health Re-search Health Technology Assessment pro-gramme (NIHR HTA). Ref: 11/129/261. EudraCT No: 2012-003476-39, CTA: 21761/0281/001-0001, Approval: 28th Nov 2012. REC Ref No.: 12/NW/0766 North West GM Central, Approval: 4th Dec 2012. The PREDNOS 2 trial has been adopted by the NIHR Clinical Research Network: Chil-dren. Thank you for taking the time to read the latest PREDNOS

2 Newsletter! We would like to wish you a very happy Easter!!!