Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

• Status: Terminated
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Enzyme Inhibitors; Mycophenolate mofetil; Mycophenolic Acid

Criteria

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