PREDNOS 2

• Research type

  Research Study

• Full title

  Short course daily prednisolone therapy at the time of upper respiratory tract infection in children with relapsing steroid sensitive nephrotic syndrome; the PREDNOS 2 study.

• IRAS ID

  111990

• Contact name

  Nicholas Webb

• Sponsor organisation

  University of Birmingham

• Eudract number

  2012-003476-39

• Research summary

  Steroid sensitive nephrotic syndrome (SSNS) is the commonest kidney disease of childhood. Large amounts of protein are leaked into the urine resulting in generalised oedema (swelling). Treatment is with high dose oral prednisolone, a steroid drug which is effective, though associated with a number of serious side-effects. Following successful initial treatment, 70-80% of children develop relapses where leakage of protein into the urine recurs. These are associated with a risk of significant complications. Treatment of relapse of nephrotic syndrome is with a further course of high dose prednisolone, further increasing the risk of side-effects. Children are kept off school, resulting in educational impairment and parental absence from work. Around 50% of children suffer frequent relapses (4 or more per year). In this situation, attempts are made to reduce prednisolone exposure using other more potent drugs e.g. ciclosporin and cyclophosphamide, which are associated with other significant side-effects. It is therefore logical to attempt to reduce the frequency of relapses. There is known to be a strong link between viral upper respiratory tract infection (URTI - the common cold) and the development of relapse of nephrotic syndrome. Three previous smalll studies have suggested that the use of a short course of daily prednisolone at the time of URTI reduces the rate of disease relapse. The PREDNOS 2 study aims to determine whether the use of such therapy effectively and safely reduces the rate of relapse in a large population of UK children. We will randomise 300 children with relapsing SSNS to receive either 6 days of daily prednisolone or continue unchanged on their existing therapy (the current standard of care) each time they develop a URTI over a 12 month period. We will assess the incidence of URTI-related relapse of nephrotic syndrome in both study arms and look carefully for side-effects of treatment.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0766

• Date of REC Opinion

  4 Dec 2012

• REC opinion

  Further Information Favourable Opinion