Clinical Trial: Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)

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

Official Title: A Prospective, Multicenter, Randomized Controlled Trial of Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)

Brief Summary: A multi-center, randomized, controlled clinical trial to evaluate the short-term and long-term efficacy and safety of mycophenolate mofetil (MMF) in reducing proteinuria and preserving renal function in patients with IgAN who have pre-treated (and continue to be treated) with angiotensin II receptor blockers (ARB), compared to the corticosteroids.

Detailed Summary:

There are four phases of study for each subject. Phase 1 the screening phase. During this phase each potential subject will be evaluated to determine if he/she is eligible for the study.

Phase 2 the ARB lead-in phase will last for three months. Phase 3 the intervention phase. Each subject will be randomly received 12 months treatment with the study drugs (MMF, prednisone or MMF plus prednisone) Phase 4 following-up phase. All the patients will be followed by 3 years after study drug stopped.

Sponsor: Sun Yat-sen University

Current Primary Outcome: Remission of proteinuria (complete or partial) [ Time Frame: up to 4.3 years ]

Original Primary Outcome: Remission of proteinuria (complete or partial) [ Time Frame: 2007-2013 ]

Current Secondary Outcome: Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation) [ Time Frame: every 6 month for 4.3 years（including 3 months ARB leading-in phase， 1 years' treatment phase and 3 years' follow-up） ]

Original Secondary Outcome: Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation) [ Time Frame: 2007-2013 ]

Information By: Sun Yat-sen University

Dates:
Date Received: April 8, 2008
Date Started: September 2007
Date Completion: April 2019
Last Updated: October 16, 2016
Last Verified: October 2016