Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA Nephropathy

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Drug: Mycophenolate Mofetil (MMF)
* Drug: MMF Placebo
* Drug: ACEi
* Drug: FOS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mycophenolate Mofetil (MMF)<br>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)<br>* Oral administration of MMF; dose based on body size (between 25mg/kg/day and 36ng/kg/day); maximum dose 1gm BID.<br>* Other names: CellCept;Drug: ACEi<br>* Administer same as pre-treatment regimen.<br>* Other names: angiotensin converting enzyme inhibitors;Drug: FOS<br>* Administer same as pre-treatment regimen<br>* Other names: fish oil supplement;|
| Placebo Comparator: MMF Placebo<br>Subjects receive MMF placebo. | Drug: MMF Placebo<br>* Placebo only, oral administration<br>Drug: ACEi<br>* Administer same as pre-treatment regimen.<br>* Other names: angiotensin converting enzyme inhibitors;Drug: FOS<br>* Administer same as pre-treatment regimen<br>* Other names: fish oil supplement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Proteinuria - Uprotein/Creatinine Ratio | Urine protein/creatinine ratio after 6 months treatment with MMF or placebo. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proteinuria, Immunoglobulin A