Clinical Trial: Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis (IMG)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Mycophenolate Mofetil and Tacrolimus vs Tacrolimus Alone for the Treatment of Idiopathic Membranous Glomerulonephritis

Brief 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 proteinuria but the remissions are often partial and patients tend to relapse when the tacrolimus treatment is stopped. We propose to use mycophenolate 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 mycophenolate mofetil. Participants will receive treatment for up to 2 years and then be monitored for relapse of their nephrotic syndrome.

Study Hypothesis: When mycophenolate mofetil is added to tacrolimus in the treatment of membranous glomerulonephritis it is likely to improve the initial response to treatment and reduce the risk of relapse on stopping therapy.

Detailed Summary:
Sponsor: Imperial College Healthcare NHS Trust

Current Primary Outcome: Efficacy of mycophenolate in preventing relapse of nephrotic syndrome secondary to membranous glomerulonephritis on withdrawal of tacrolimus therapy. This will be initially measured at 6 months post withdrawal of tacrolimus therapy. [ Time Frame: 6 months post withdrawl or tacrolimus therapy ]

Original Primary Outcome: Efficacy of MMF in preventing relapse of nephrotic syndrome secondary to membranous glomerulonephritis on withdrawal of tacrolimus therapy. This will be initially measured at 6 months post withdrawal of tacrolimus therapy. [ Time Frame: 6 months post withdrawl or tacrolimus therapy ]

Current Secondary Outcome: The time to obtaining remission from proteinuria The degree of remission of proteinuria obtained (complete or partial) The rate of decline of renal function measured by the Modification of Diet in Renal Disease equation for glomerular filtration rate [ Time Frame: 6-12 months ]

Original Secondary Outcome: The time to obtaining remission from proteinuria The degree of remission of proteinuria obtained (complete or partial) The rate of decline of renal function measured by the MDRD equation for glomerular filtration rate [ Time Frame: 6-12 months ]

Information By: Imperial College Healthcare NHS Trust

Dates:
Date Received: February 12, 2009
Date Started: February 2009
Date Completion: February 2018
Last Updated: March 3, 2017
Last Verified: March 2017