Please note that the PREDNOS 2 Office, including the telephone randomisation system will be closed from 13:00, Friday 21st December 2018 until 09:00, Thursday 3rd January 2019.

The online randomisation and data entry service will still be available over the Christmas period.

 

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: 360 patients will be recruited into the study (180 in each arm).

Study Duration: The accrual period is for 71 months 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 94 months.

Timeframes: NIHR HTA grant start date: 1st October 2012. Trial set up took place in 5 months, recruitment will take 71 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 V3.0 (1st August 2018)

PREDNOS 2 Online Randomisation and Data Entry

Contact the PREDNOS 2 trial team

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Chief Investigator: Dr Martin Christian

Trial Co-Sponsor: Manchester University 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

MHRA 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