Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy
| Status: | Terminated |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 7 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | January 2002 |
| End Date: | March 2010 |
A Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA Nephropathy
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).
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).
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).
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
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