PREDnisolone in NephrOtic Syndrome (PREDNOS)

Welcome to the PREDNOS website.

PREDNOS is a national multicentre randomised double blind trial of long-term tapering versus standard prednisolone (steroid) therapy for the treatment of the initial episode of childhood nephrotic syndrome.

Trial details

Aim of the study

To compare an extended (sixteen week) tapering prednisolone regimen with the standard eight week regimen as originally proposed by the International Study of Kidney Disease in Children (ISKDC).

PREDNOS Sample Size

A total of 236 children will be recruited into the study (118 in each arm).

PREDNOS Study Duration

The study duration is 5 years 10 months in total, with an accrual period of 40 months.

Randomisation has now closed following recruitment of 237 patients into the trial. Please note that, although recruitment to this study has now ended, the study is still open and is now in the follow-up phase. All participants in the trial will be followed up for a minimum of 24 months and a maximum of 48 months (variable depending on the date of randomisation).  We hope to publish the final report in March 2017.

 


 

Chief Investigator: Professor Nicholas Webb

Trial Sponsor: University of Birmingham and Central Manchester University Hospitals NHS Foundation Trust

Funding: National Institute for Health Research Health Technology Assessment programme (NIHR HTA)

http://www.hta.ac.uk/index.shtml

North West 7 REC - GM Central Reference No: 10/H1008/122

EudraCT Number: 2010-022489-29

REC Approval date: 5th April 2011 (Ref: 10/H1008/122)

MHRA Approval date: 23rd December 2010 (CTA: Ref: 21761/0255/001-0001)