Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy
IgA nephropathy (IgAN) is the most common type of glomerulonephritis worldwide. 15-40% of individuals diagnosed with IgAN, including children, will eventually progress to chronic renal insufficiency (CRI) and end stage renal disease (ESRD). The study is to evaluate the safety and benefits of MMF in patients with IgAN who have been pre-treated (and continue to be treated) with angiotensin converting enzyme inhibitors (ACEi) and fish oil supplements (FOS).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA Nephropathy|
- Change in Proteinuria - Uprotein/Creatinine Ratio [ Time Frame: Plan was to measure uprotein/creatinine ratio for 12 months on MMF or placebo, and then 12 months post-treatment. Data given after 6 months MMF/placebo. ] [ Designated as safety issue: No ]Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.
- Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2002|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Mycophenolate Mofetil (MMF)
Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.
Drug: Mycophenolate Mofetil (MMF)
Placebo Comparator: Placebo
Subjects receive ACEi and FOS and placebo.
A multi-center, randomized, controlled clinical trial to test the hypothesis that treatment with mycophenolate mofetil (MMF) will lead to significant and sustained improvement in proteinuria in patients with IgA Nephropathy who have been pre-treated (and continue to be treated) with ACEi and FOS compared to a placebo control group of patients receiving comparable doses of ACEi and FOS without MMF. Data for this outcome will be examined every six months and at the end of 2 years of study. Comparisons will be made between the two treatment groups for change from entry level in urine protein to creatinine (UPr/Cr) ratio, 24-hour urine protein excretion rate and estimated glomerular filtration rate (GFR).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318474
|United States, Arizona|
|St. Joseph's Hospital and Medical Center|
|Phoenix, Arizona, United States, 85013|
|Principal Investigator:||Ronald J Hogg, M.D.||St. Joseph's Hospital and Medical Center, Phoenix|