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Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

Primary Purpose

IgA Nephropathy

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Mycophenolate Mofetil (MMF)
MMF Placebo
ACEi
FOS
Sponsored by
St. Joseph's Hospital and Medical Center, Phoenix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring Proteinuria, Immunoglobulin A

Eligibility Criteria

7 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Hospital and Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mycophenolate Mofetil (MMF)

MMF Placebo

Arm Description

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.

Subjects receive MMF placebo.

Outcomes

Primary Outcome Measures

Change in Proteinuria - Uprotein/Creatinine Ratio
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

Full Information

First Posted
April 24, 2006
Last Updated
February 4, 2016
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
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1. Study Identification

Unique Protocol Identification Number
NCT00318474
Brief Title
Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy
Official Title
A Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
DSMB recommended stopping the trial because of lack of effect.
Study Start Date
January 2002 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Joseph's Hospital and Medical Center, Phoenix

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
Keywords
Proteinuria, Immunoglobulin A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mycophenolate Mofetil (MMF)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MMF Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects receive MMF placebo.
Intervention Type
Drug
Intervention Name(s)
Mycophenolate Mofetil (MMF)
Other Intervention Name(s)
CellCept
Intervention Description
Oral administration of MMF; dose based on body size (between 25mg/kg/day and 36ng/kg/day); maximum dose 1gm BID.
Intervention Type
Drug
Intervention Name(s)
MMF Placebo
Intervention Description
Placebo only, oral administration
Intervention Type
Drug
Intervention Name(s)
ACEi
Other Intervention Name(s)
angiotensin converting enzyme inhibitors
Intervention Description
Administer same as pre-treatment regimen.
Intervention Type
Drug
Intervention Name(s)
FOS
Other Intervention Name(s)
fish oil supplement
Intervention Description
Administer same as pre-treatment regimen
Primary Outcome Measure Information:
Title
Change in Proteinuria - Uprotein/Creatinine Ratio
Description
Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.
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.
Secondary Outcome Measure Information:
Title
Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald J Hogg, M.D.
Organizational Affiliation
St. Joseph's Hospital and Medical Center, Phoenix
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States

12. IPD Sharing Statement

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Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

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