Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00318474
Recruitment Status : Terminated (DSMB recommended stopping the trial because of lack of effect.)
First Posted : April 26, 2006
Results First Posted : October 1, 2014
Last Update Posted : March 7, 2016
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

April 24, 2006
April 26, 2006
June 3, 2014
October 1, 2014
March 7, 2016
January 2002
March 2008   (Final data collection date for primary outcome measure)
Change in Proteinuria - Uprotein/Creatinine Ratio [ Time Frame: 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. ]
Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.
Fall in proteinuria
Complete list of historical versions of study NCT00318474 on Archive Site
Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level [ Time Frame: 12 months ]
Fall in estimated GFR to less than 60% of the baseline level
Not Provided
Not Provided
Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy
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).
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).
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
IgA Nephropathy
  • Drug: Mycophenolate Mofetil (MMF)
    Oral administration of MMF; dose based on body size (between 25mg/kg/day and 36ng/kg/day); maximum dose 1gm BID.
    Other Name: CellCept
  • Drug: MMF Placebo
    Placebo only, oral administration
  • Drug: ACEi
    Administer same as pre-treatment regimen.
    Other Name: angiotensin converting enzyme inhibitors
  • Drug: FOS
    Administer same as pre-treatment regimen
    Other Name: fish oil supplement
  • Active Comparator: 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.
    • Drug: Mycophenolate Mofetil (MMF)
    • Drug: ACEi
    • Drug: FOS
  • Placebo Comparator: MMF Placebo
    Subjects receive MMF placebo.
    • Drug: MMF Placebo
    • Drug: ACEi
    • Drug: FOS
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2010
March 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
7 Years to 70 Years   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
IND #48,977 ( Other Identifier: Food and Drug Administration )
Canadian Control #076948 ( Other Identifier: Bureau of Pharmaceutical Assessment - Canada )
Not Provided
Not Provided
St. Joseph's Hospital and Medical Center, Phoenix
St. Joseph's Hospital and Medical Center, Phoenix
Not Provided
Principal Investigator: Ronald J Hogg, M.D. St. Joseph's Hospital and Medical Center, Phoenix
St. Joseph's Hospital and Medical Center, Phoenix
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP