Clinical Trial: Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Controlled Multi-center Trial of Mycophenolate Mofetil for the Patient With High Risk Membranous Nephropathy

Brief Summary: Cyclosporin decreases proteinuria and improve renal function in patients with idiopathic membranous nephropathy, but has a risk of side effects such as nephrotoxicity. The investigators plan to the study to evaluate whether mycophenolate mofetil (MMF) could be a reasonable alternative with fewer side effect.

Detailed Summary: Idiopathic membranous nephropathy is most common cause of glomerulonephritis in adults. Persistent high grade proteinuria or progressively decrease of renal function is a risk factor for end stage renal disease in idiopathic membranous nephropathy. It has been reported that cyclosporin in patients with idiopathic membranous nephropathy decreases proteinuria and improve renal function. Mycophenolate mofetil is a recently developed immunosuppressive agent with fewer side effect than cyclosporin. In this study patients with high risk group of progressive idiopathic membranous nephropathy will be treated with mycophenolate mofetil and low dose prednisone. The outcome will be compared to controls treated with cyclosporin and low dose prednisone.
Sponsor: Kyungpook National University

Current Primary Outcome:

• Percentage of complete remission [ Time Frame: at 48 week after treatment ]
  Complete remission: Reduction in proteinuria to 200 mg per day with stable serum albumin with more than 3.5 g/dL
• Percentage of partial remission [ Time Frame: at 48 week after treatment ]
  Partial remission: Reduction in proteinuria to greater than 50 percent of initial values or absolute values of proteinuria between 200 mg and 3.5 g per day

Original Primary Outcome: Percentage of partial remission and complete remission [ Time Frame: at 1 year after treatment ]

Current Secondary Outcome:

• estimated Glomerular filtration rate (eGFR) [ Time Frame: at 48 week after treatment ]
  The change of eGFR mesured by Modification of Diet in Renal Disease (MDRD) study equation from baseline to 1 year after treatment
• Relapse [ Time Frame: For 48 weeks after treatment ]
  A relapse is return of proteinuria to approximately 3.5g/day in patients who had previously undergone a complete or partial remission
• Proteinuria [ Time Frame: at 48 week after treatment ]
  The change of proteinuria from baseline to 48 week after treatment
• Side effects [ Time Frame: For 48 weeks after treatment ]
  Any undesired effects of interventional drugs

Original Secondary Outcome: eGFR, proteinuria, relapse, side effects [ Time Frame: at 1 year after treatment ]

Information By: Kyungpook National University

Dates:
Date Received: January 19, 2011
Date Started: March 2011
Date Completion: July 2017
Last Updated: April 9, 2015
Last Verified: April 2015