Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

IgA Nephropathy Clinical Trial

Official title:

A Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA Nephropathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00318474
• Other study ID #: 04PE116
• Secondary ID: IND #48,977Canad
• Status: Terminated
• Phase: Phase 3
• First received: April 24, 2006
• Last updated: February 4, 2016
• Start date: January 2002
• Est. completion date: March 2010

Study information

• Verified date: February 2016
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 184
• Est. completion date: March 2010
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

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.
• MMF Placebo
Placebo only, oral administration
• ACEi
Administer same as pre-treatment regimen.
• FOS
Administer same as pre-treatment regimen

Locations

Country	Name	City	State
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Hospital and Medical Center, Phoenix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level		12 months	No