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Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

NCT00318474 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2016-03-07

Study results available
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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).

Conditions

Interventions

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.

DRUG

MMF Placebo

Placebo only, oral administration

DRUG

ACEi

Administer same as pre-treatment regimen.

DRUG

FOS

Administer same as pre-treatment regimen

Sponsors & Collaborators

  • St. Joseph's Hospital and Medical Center, Phoenix

    lead OTHER

Principal Investigators

  • Ronald J Hogg, M.D. · St. Joseph's Hospital and Medical Center, Phoenix

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2008-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00318474 on ClinicalTrials.gov