Clinical trial NCT00318474: Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy
Official title: A Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA Nephropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: IgA Nephropathy
Keywords: Proteinuria
Immunoglobulin A
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
First posted: 2006-04-26
Enrollment: 184
Sex: ALL
Minimum age (years): 7
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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).

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 glomerular filtration rate (GFR).

Eligibility 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

Primary outcomes:
measure: Change in Proteinuria - Uprotein/Creatinine Ratio
timeFrame: Plan was to measure uprotein/creatinine ratio for 12 months on MMF or placebo, and then 12 months post-treatment. Data given after 6 months MMF/placebo.
Secondary outcomes:
measure: Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level
timeFrame: 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
Study officials:
affiliation: St. Joseph's Hospital and Medical Center, Phoenix
name: Ronald J Hogg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: