Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

St. Joseph's Hospital and Medical Center, Phoenix

Status and phase: Terminated; Phase 3

Conditions: IgA Nephropathy

Treatments: Drug: MMF Placebo; Drug: ACEi; Drug: FOS; Drug: Mycophenolate Mofetil (MMF)

Study type: Interventional

Funder types: Other

Identifiers

NCT00318474

Canadian Control #076948 (Other Identifier)

IND #48,977 (Other Identifier)

04PE116

Details and patient eligibility

About

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).

Full 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).

Enrollment: 184 patients

Sex: All

Ages: 7 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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184 participants in 2 patient groups, including a placebo group

Mycophenolate Mofetil (MMF)

Active Comparator group

Description:

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.

Treatment:

Drug: Mycophenolate Mofetil (MMF)

Drug: FOS

Drug: ACEi

MMF Placebo

Placebo Comparator group

Description:

Subjects receive MMF placebo.

Treatment:

Drug: FOS

Drug: ACEi

Drug: MMF Placebo