Status:
TERMINATED
Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy
Lead Sponsor:
St. Joseph's Hospital and Medical Center, Phoenix
Conditions:
IgA Nephropathy
Eligibility:
All Genders
7-70 years
Phase:
PHASE3
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 (...
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 patien...
Eligibility Criteria
Inclusion
- Patients ages 7-70 years old
- Renal biopsy, diagnostic for IgA nephropathy
- Must be able to take oral medication
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT00318474
Start Date
January 1 2002
End Date
March 1 2010
Last Update
March 7 2016
Active Locations (1)
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1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013