Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

Phase 3TerminatedNCT00318474

St. Joseph's Hospital and Medical Center, Phoenix184 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

184

Conditions

IgA Nephropathy

Interventions

Mycophenolate Mofetil (MMF)DRUG

Oral administration of MMF; dose based on body size (between 25mg/kg/day and 36ng/kg/day); maximum dose 1gm BID.

MMF PlaceboDRUG

Placebo only, oral administration

ACEiDRUG

Administer same as pre-treatment regimen.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Change in Proteinuria - Uprotein/Creatinine Ratio

Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.

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.

Secondary Outcomes

Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level

Time frame: 12 months

Data from ClinicalTrials.gov

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