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Completed Phase 3 Interventional Results available

A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.

ClinicalTrials.gov ID: NCT00377637

Public ClinicalTrials.gov record NCT00377637. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 2:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective, Randomized, Active Controlled, Parallel Group, Multi-center Trial to Assess the Efficacy and Safety of Mycophenolate Mofetil (MMF) in Inducing Response and Maintaining Remission in Subjects With Lupus Nephritis.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of MMF compared to azathioprine in maintaining remission and renal function. Patients were randomized to receive either MMF (1.5 g twice daily \[bid\]) or cyclophosphamide (0.5-1.0 g/m\^2 in monthly pulses) in the induction phase. Those patients meeting criteria for response were re-randomized for entry into the maintenance phase, to receive either MMF (1 g bid) or azathioprine (2 mg/kg/day).

Study identification

NCT ID
NCT00377637
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
370 participants

Conditions and interventions

Eligibility (public fields only)

Age range
12 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2005
Primary completion
Feb 28, 2007
Completion
Feb 28, 2010
Last update posted
Dec 5, 2011

2005 – 2010

United States locations

U.S. sites
28
U.S. states
16
U.S. cities
25
Facility City State ZIP Site status
Not listed Huntsville Alabama 35801
Not listed La Jolla California 92037
Not listed Los Angeles California 90095
Not listed San Francisco California 94143
Not listed San Leandro California 94578
Not listed Torrance California 90502
Not listed Miami Florida 33136
Not listed Atlanta Georgia 30303
Not listed Chicago Illinois 60611
Not listed Chicago Illinois 60637
Not listed Baltimore Maryland 21205
Not listed Boston Massachusetts 02115
Not listed Ann Arbor Michigan 48109-0358
Not listed Columbia Missouri 65212
Not listed Brooklyn New York 11203
Not listed Lake Success New York 11042
Not listed New York New York 10003
Not listed New York New York 10021
Not listed New York New York 10032
Not listed Chapel Hill North Carolina 27599-7280
Not listed Durham North Carolina 27710
Not listed Cleveland Ohio 44136
Not listed Columbus Ohio 43210
Not listed Oklahoma City Oklahoma 73104
Not listed Philadelphia Pennsylvania 19104
Not listed Pittsburgh Pennsylvania 15213
Not listed Charleston South Carolina 29425
Not listed Dallas Texas 75390

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 80 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00377637, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 5, 2011 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00377637 live on ClinicalTrials.gov.

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