Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

Phase 3

Terminated

Interventions: Drug: Mycophenolate Mofetil (MMF)
Drug: MMF Placebo
Drug: ACEi
Drug: FOS

Brief Summary: 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).

Detailed Description: 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).

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Mycophenolate Mofetil (MMF)	Mycophenolate Mofetil (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.
Mycophenolate Mofetil (MMF)	ACEi	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.
Mycophenolate Mofetil (MMF)	FOS	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.
MMF Placebo	ACEi	Subjects receive MMF placebo.
MMF Placebo	FOS	Subjects receive MMF placebo.
MMF Placebo	MMF Placebo	Subjects receive MMF placebo.

Primary Outcome Measures

Name	Time	Method
Change in Proteinuria - Uprotein/Creatinine Ratio	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.	Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.

Secondary Outcome Measures