Christmas and New Year Arrangements
Please note that the Birmingham Clinical Trials Unit will be closed from 2:00pm on Thursday 22nd December 2016 until 9:00am on Wednesday 4th January 2017. The online randomisation system and trial database will remain available throughout this period. Please report any SAEs directly to Professor Nick Webb by email during this time: Nicholas.Webb@cmft.nhs.uk.
Birmingham Children’s Hospital Pharmacy will only be able to send out PREDNOS 2 trial medication on the following days: service as normal up until 12pm on Wednesday 21st December 2016, and between Wednesday 28th December 2016 and Friday 30th December 2016. Normal service will then resume Tuesday 3rd January 2017. The pharmacy will actually be closed from Saturday 24th December 2016 to Tuesday 27th December 2016, and between Saturday 31st December 2016 and Monday 2nd January 2017.
The first patient was randomised to the Prednos 2 trial by Royal Mancher Children’s Hospital on the 19th March 2013.
The PREDNOS 2 study medication has been available since 14th February 2013 and the Online Randomisation and Data Entry application was released on 22nd February 2013.
All MHRA, REC and R&D approvals are now in place. REC approval date 4th December 2012 (Ref: 12/NW/0766) and MHRA CTA approval 28th Nov 2012 (Ref: 21761/0281/001-0001). We are also UK CRN portfolio adopted and look forward to working with the MCRN to make PREDNOS 2 a success (Ref: 13410).
The PREDNOS 2 protocol and documentation has been circulated to all collaborators and is available on the PREDNOS 2 website for centres to use. If you have any queries regarding PREDNOS 2 or need any assistance in completing your SSI form please contact the PREDNOS 2 study office: PREDNOS2@trials.bham.ac.uk.
The PREDNOS 2 Study
The PREDNOS 2 study will evaluate short course daily prednisolone therapy at the time of upper respiratory tract infection in children with relapsing steroid sensitive nephrotic syndrome. As in PREDNOS 1, the Chief Investigator is Professor Nick Webb, Royal Manchester Children's Hospital, and the trial is co-sponsored by Central Manchester University Hospitals NHS Foundation Trust and University of Birmingham. The trial has been funded by the National Institute for Health Research Health Technology Assessment programme (HTA 11/119/261). PREDNOS 2 will randomise 300 patients over a 2 year recruitment period and all subjects will be followed up for 12 months.
The total study duration is 4 years. The aim of the study is 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.
Thank you to all of our collaborators
We would like to take this opportunity to thank all of our collaborators for considering the PREDNOS 2 study. We have received an exceptional amount of interest from centres across the United Kingdom and can now confirm over 120 centres will be participating. Thank you for your support and we look forward to working with you on the PREDNOS 2 study.
PREDNOS 2 start date
The PREDNOS 2 grant start date was 1st October 2012 and as the HTA funding was a rapid call we needed to randomise the first patient by the end of March 2013.