Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
IgA Nephropathy |
Drug: Mycophenolate Mofetil (MMF) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA Nephropathy |
- Fall in proteinuria [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Fall in estimated glomerular filtration rate (GFR) to less than 60% of the baseline level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 184 |
| Study Start Date: | January 2002 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Mycophenolate Mofetil (MMF)
Subjects receive ACEi, FOS, and MMF. 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.
|
Drug: Mycophenolate Mofetil (MMF)
NA
|
|
Placebo Comparator: Placebo
Subjects receive ACEi and FOS and placebo.
|
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 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 GFR.
Eligibility| Ages Eligible for Study: | 7 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Arizona | |
| St. Joseph's Hospital and Medical Center | |
| Phoenix, Arizona, United States, 85013 | |
| Principal Investigator: | Ronald J Hogg, M.D. | St. Joseph's Hospital and Medical Center, Phoenix |
More Information
No publications provided
| Responsible Party: | St. Joseph's Hospital and Medical Center, Phoenix |
| ClinicalTrials.gov Identifier: | NCT00318474 History of Changes |
| Other Study ID Numbers: | 04PE116, 48,977 (FDA), 076948 (BPA-Canada) |
| Study First Received: | April 24, 2006 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by St. Joseph's Hospital and Medical Center, Phoenix:
|
Proteinuria Immunoglobulin A |
Additional relevant MeSH terms:
|
Glomerulonephritis, IGA Kidney Diseases Glomerulonephritis Nephritis Urologic Diseases Autoimmune Diseases Immune System Diseases Mycophenolate mofetil Mycophenolic Acid |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013