Tacrolimus vs tacrolimus and mycophenylate mofetil for membranous glom

• Research type

  Research Study

• Full title

  Tacrolimus vs tacrolimus and mycophenylate mofetil, a randomised control trial for treatment of idiopathic membranous nephropathy

• Contact name

  Megan Griffith

• Sponsor organisation

  Research and Development Department, Imperial College Healthcare NHS Trust

• Eudract number

  2008-001009-41

• ISRCTN Number

  Not submitted

• Research summary

  Membranous nephropathy is a common cause of nephrotic syndrome in adults. It is difficult to treat and if persistent leads to end stage renal failure in a significant number of patients. It is currently treated in this institution with tacrolimus monotherapy. This is effective in the majority of patients in reducing loss of protein from the kidney, but the remissions are often partial and patients tend to relapse when the tacrolimus treatment is stopped. We propose to use mycophenylate mofetil in combination with tacrolimus with the aim of obtaining a more complete initial response to treatment, a decreased rate of relapse on withdrawal of therapy and less progression of renal failure. This will be a randomised control trial, patients will be randomised to receive treatment with tacrolimus alone (our current standard therapy) or treatment with tacrolimus and mycophenylate mofetil. Participants will receive treatment for up to 2 years and then be monitored for relapse of their nephrotic syndrome. The research is sponsored by Imperial College Healthcare NHS trust and patients will be recruited from the Glomerulonephritis clinic at Hammersmith Hospital.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  08/H0720/90

• Date of REC Opinion

  8 Oct 2008

• REC opinion

  Further Information Favourable Opinion