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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.
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
IgA Nephropathy Drug: Mycophenolate Mofetil (MMF) Drug: MMF Placebo Drug: ACEi Drug: FOS Phase 3

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA Nephropathy
Study Start Date : January 2002
Primary Completion Date : March 2008
Study Completion Date : March 2010


Arms and Interventions

Arm Intervention/treatment
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)
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: 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
Placebo Comparator: MMF Placebo
Subjects receive MMF placebo.
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   7 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: Food and Drug Administration )
Canadian Control #076948 ( Other Identifier: Bureau of Pharmaceutical Assessment - Canada )
First Posted: April 26, 2006    Key Record Dates
Results First Posted: October 1, 2014
Last Update Posted: March 7, 2016
Last Verified: February 2016

Keywords provided by St. Joseph's Hospital and Medical Center, Phoenix:
Proteinuria
Immunoglobulin A

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors