Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier:
NCT00318474
First received: April 24, 2006
Last updated: January 28, 2013
Last verified: January 2013

April 24, 2006
January 28, 2013
January 2002
March 2008   (final data collection date for primary outcome measure)
Fall in proteinuria [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Fall in proteinuria
Complete list of historical versions of study NCT00318474 on ClinicalTrials.gov Archive Site
Fall in estimated glomerular filtration rate (GFR) to less than 60% of the baseline level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 GFR.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
IgA Nephropathy
Drug: Mycophenolate Mofetil (MMF)
NA
  • 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.
    Intervention: Drug: Mycophenolate Mofetil (MMF)
  • Placebo Comparator: Placebo
    Subjects receive ACEi and FOS and placebo.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
184
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
Both
7 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00318474
04PE116, 48,977 (FDA), 076948 (BPA-Canada)
Yes
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
January 2013

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