PREDNOS 2

PREDNOS 2 is a national multicentre double blind randomised controlled trial of short course daily prednisolone therapy at the time of upper respiratory tract infection in children with relapsing steroid sensitive nephrotic syndrome (SSNS).

Trial details

Full Title: Short course daily prednisolone therapy at the time of upper respiratory tract infection in children with relapsing steroid sensitive nephrotic syndrome

Short Title: PREDNOS 2 study

Aim of the study: To evaluate the effectiveness of a six day course of daily prednisoline therapy at the time of URTI in reducing the development of subsequent nephrotic syndrome relapse in children with relapsing SSNS.

Study design: Double blind randomised controlled trial (RCT).

Sample size: 300 patients will be recruited into the study (150 in each arm) over a 2 year period.

Study Duration: The accrual period is for 2 years and all patients will be followed up for 12 months. The end of trial will be 6 months after the last data capture. The last data capture will be 12 months following recruitment of the last patient. The total study duration is 4 years.

Timeframes: NIHR HTA grant start date: 1st October 2012. Trial set up will take place in 6 months, recruitment will take 24 months, all patients will be followed up for 12 months and 6 months has been allocated for data analysis and report writing. The first patient was randomised on 19th March 2013.

PREDNOS 2 Protocol V1.3 (29th April 2015)

PREDNOS 2 Online Randomisation and Data Entry

Contact the PREDNOS 2 trial team

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.

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Chief Investigator: Professor Nicholas Webb

Trial Co-Sponsor: Central Manchester University Hospitals NHS Foundation Trust and University of Birmingham (Ref: RG_12-188)

Funding: National Institute for Health Research Health Technology Assessment programme (NIHR HTA) Ref: 11/129/261

EudraCT Number: 2012-003476-39

MHTA CTA: 21761/0281/001-0001 (28th November 2012)

Research Ethics Committee: North West GM Central (Ref: 12/NW/0766) (4th December 2012)

ISRCTN10900733

NIHR CRN Study ID: 13410