Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

This study has been terminated.
(DSMB recommended stopping the trial because of lack of effect.)
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: September 24, 2014
Last verified: September 2014
  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

Resource links provided by NLM:


Further study details as provided by St. Joseph's Hospital and Medical Center, Phoenix:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.


Secondary Outcome Measures:
  • Change 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 glomerular filtration rate (GFR).

  Eligibility

Ages Eligible for Study:   7 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318474

Locations
United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Investigators
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, IND #48,977, Canadian Control #076948
Study First Received: April 24, 2006
Results First Received: June 3, 2014
Last Updated: September 24, 2014
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
Autoimmune Diseases
Glomerulonephritis
Immune System Diseases
Nephritis
Urologic Diseases
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014