PREDnisolone in NephrOtic Syndrome: The PREDNOS study

• Research type

  Research Study

• Full title

  Long-term tapering versus standard prednisolone (steroid) therapy for the treatment of the initial episode of childhood nephrotic syndrome: national multicentre randomised double blind trial

• IRAS ID

  59508

• Contact name

  Nicholas J A Webb

• Sponsor organisation

  The University of Birmingham

• Eudract number

  2010-022489-29

• ISRCTN Number

  16645249

• Research summary

  PREDNOS is a UK, multi-centre, double blind randomised controlled trial. The aim of the trial is to compare an extended course (sixteen week) tapering prednisolone regimen with the standard eight week regimen as originally proposed by the International Study of Kidney Disease in Children (ISKDC). The primary study objective is to determine whether an extended course of prednisolone increases the time to first relapse in children presenting with steroid sensitive nephrotic syndrome. The standard course of therapy (eight weeks) is: Weeks 1 - 4, Prednisolone 60mg/m2/day (max 80mg), Weeks 5 - 8: Prednisolone 40mg/m2 (max 60mg) on alternate days for 28 days. This will be compared with an extended course of therapy (sixteen weeks): Weeks 1 - 4, Prednisolone 60mg/m2/day (max 80mg), Weeks 5-16: Prednisolone 60mg/m2 (max 80mg) on alternate days tapering by 10mg/m2 every 2 weeks. Recruitment and randomisation will occur during the initial four week open label treatment during which all children will be treated in accordance with existing national protocols with prednisolone 60mg/m2 (maximum 80mg) daily in an open label manner to ascertain whether they are steroid sensitive and as such eligible for recruitment into the study. The randomised study drug regimen will commence at day 29. The study is double blinded through the use of prednisolone 5mg and matching placebo tablets and children in both treatment arms will receive the same number of tablets at any time-point in the study. Recruitment will take place over a period of two years. All patients will be followed up for at least 24 months and for a variable time period beyond 24 months, until 2 years following the recruitment of the last patient.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/H1008/122

• Date of REC Opinion

  5 Apr 2011

• REC opinion

  Further Information Favourable Opinion