A Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA Nephropathy
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 184
- Locations
- 1
- Primary Endpoint
- Change in Proteinuria - Uprotein/Creatinine Ratio
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 7 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Mycophenolate Mofetil (MMF) (Drug)
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.
Intervention: ACEi (Drug)
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.
Intervention: FOS (Drug)
MMF Placebo
Subjects receive MMF placebo.
Intervention: MMF Placebo (Drug)
MMF Placebo
Subjects receive MMF placebo.
Intervention: ACEi (Drug)
MMF Placebo
Subjects receive MMF placebo.
Intervention: FOS (Drug)
Outcomes
Primary Outcomes
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.
Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.
Secondary Outcomes
- Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level(12 months)