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).

Study Overview

• Status: Terminated
• Conditions: IgA Nephropathy
• Intervention / Treatment: Drug: Mycophenolate Mofetil (MMF); Drug: ACEi; Drug: FOS; Drug: MMF 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).

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital and Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 68 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: CellCept; Drug: ACEi; Administer same as pre-treatment regimen.; Other Names: angiotensin converting enzyme inhibitors; Drug: FOS; Administer same as pre-treatment regimen; Other Names: fish oil supplement
Placebo Comparator: MMF Placebo; Subjects receive MMF placebo.	Drug: ACEi; Administer same as pre-treatment regimen.; Other Names: angiotensin converting enzyme inhibitors; Drug: FOS; Administer same as pre-treatment regimen; Other Names: fish oil supplement; Drug: MMF Placebo; Placebo only, oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Proteinuria - Uprotein/Creatinine Ratio	Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.	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.

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level	12 months

Collaborators and Investigators

• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Investigators: Principal Investigator: Ronald J Hogg, M.D., St. Joseph's Hospital and Medical Center, Phoenix

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: April 24, 2006
• First Submitted That Met QC Criteria: April 24, 2006
• First Posted (Estimate): April 26, 2006

Study Record Updates

• Last Update Posted (Estimate): March 7, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Proteinuria; Immunoglobulin A
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Kidney Diseases; Glomerulonephritis, IGA; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Protease Inhibitors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Mycophenolic Acid; Enzyme Inhibitors; Angiotensin-Converting Enzyme Inhibitors
• Other Study ID Numbers: 04PE116; IND #48,977 (Other Identifier: Food and Drug Administration); Canadian Control #076948 (Other Identifier: Bureau of Pharmaceutical Assessment - Canada)