Tacrolimus vs prednisolone for minimal change disease

• Research type

  Research Study

• Full title

  Tacrolimus vs prednisolone for the treatment of nephrotic syndrome secondary to minimal change disease: A Randomised Control Trial

• IRAS ID

  25459

• Eudract number

  2009-014292-52

• ISRCTN Number

  TBA

• Research summary

  Minimal change disease is a common cause of nephrotic syndrome in adults. The current standard treatment is with high dose corticosteroids. Although this treament is effective in the majority of patients, many patients suffer from significant side effects from the treatment and the disease often relapses when the treatment is stopped. We propose to use tacrolimus to treat minimal change disease with the aim of effectively treating the disease with minimal side effects and investigating if this results in a decreased rate of relapse on withdrawal of therapy. This will be a randomised controlled trial, patients will be randomised to receive prednisolone (our current standard therapy) or tacrolimus. Patients will receive treatment for between 4 and 11 months depending how quickly their disease responds and will be monitored for relapse of their nephrotic syndrome over 2 years in the nephrology clinic.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  09/H0711/68

• Date of REC Opinion

  28 Oct 2009

• REC opinion

  Further Information Favourable Opinion