Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2010-03-31

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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IgA Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mycophenolate Mofetil (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.

Group Type ACTIVE_COMPARATOR

Mycophenolate Mofetil (MMF)

Intervention Type DRUG

Oral administration of MMF; dose based on body size (between 25mg/kg/day and 36ng/kg/day); maximum dose 1gm BID.

ACEi

Intervention Type DRUG

Administer same as pre-treatment regimen.

FOS

Intervention Type DRUG

Administer same as pre-treatment regimen

MMF Placebo

Subjects receive MMF placebo.

Group Type PLACEBO_COMPARATOR

MMF Placebo

Intervention Type DRUG

Placebo only, oral administration

ACEi

Intervention Type DRUG

Administer same as pre-treatment regimen.

FOS

Intervention Type DRUG

Administer same as pre-treatment regimen

Interventions

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Mycophenolate Mofetil (MMF)

Oral administration of MMF; dose based on body size (between 25mg/kg/day and 36ng/kg/day); maximum dose 1gm BID.

Intervention Type DRUG

MMF Placebo

Placebo only, oral administration

Intervention Type DRUG

ACEi

Administer same as pre-treatment regimen.

Intervention Type DRUG

FOS

Administer same as pre-treatment regimen

Intervention Type DRUG

Other Intervention Names

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CellCept angiotensin converting enzyme inhibitors fish oil supplement

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No