Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

A Randomized Controlled Trial of Mycophenolate Mofetil 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).

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).

Inclusion Criteria:

• Patients ages 7-70 years old
• Renal biopsy, diagnostic for IgA nephropathy
• Must be able to take oral medication

Exclusion Criteria:

• Clinical and histologic evidence of systemic lupus erythematosus
• Well-documented history of Henoch-Schonlein purpura.
• Clinical evidence of cirrhosis or chronic liver disease
• Abnormal laboratory values at the time of study entry
• Estimated GFR outside of protocol defined limits
• History of significant gastrointestinal disorder
• Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C.
• Other major organ system disease or malignancy
• Current or prior treatment with MMF or azathioprine