Study of Therapeutic Monitoring of Mycophenolate Mofetil (MMF/CellCept) After Kidney Transplantation

ClinicalTrials.gov ID: NCT00087581

Public ClinicalTrials.gov record NCT00087581. 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.

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ClinicalTrials.gov public records Last synced Oct 23, 2026, 9:09 AM EDT

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

Official title

An Open-Label, Prospective, Randomized, Controlled, Multi-Center Study Assessing Fixed Dose Versus Concentration Controlled Cellcept® Regimens for Patients Following a Single Organ Renal Transplantation in Combination With Full Dose and Reduced Dose Calcineurin Inhibitors

Brief summary

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

This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF combined with various dosing regimens of calcineurin inhibitor (CNI), either cyclosporine or tacrolimus, in participants who have undergone kidney transplantation. Participants will be randomized to one of three dosing regimens to receive concentration-controlled MMF with reduced CNI, concentration-controlled MMF with standard CNI, or fixed-dose MMF with standard CNI. Participants will be followed for 20-24 months after randomization.

Study identification

NCT ID: NCT00087581
Recruitment status: Completed
Study type: Interventional
Phase: Phase 4
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 720 participants

Conditions and interventions

Conditions

Kidney Transplantation

Interventions

Drug

Eligibility (public fields only)

Age range: 13 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 2004 (Type not available)
Primary completion: Sep 2007 (Actual)
Completion: Sep 2007 (Actual)
Last update posted: Nov 7, 2016

2004 – 2007

United States locations

U.S. sites: 57
U.S. states: 29
U.S. cities: 51

Facility	City	State	ZIP	Site status
Not listed	Birmingham	Alabama	35294	—
Not listed	Little Rock	Arkansas	72205	—
Not listed	Bakersfield	California	93309	—
Not listed	Los Angeles	California	90048	—
Not listed	Los Angeles	California	90057	—
Not listed	San Francisco	California	94143-0116	—
Not listed	Denver	Colorado	80262	—
Not listed	Gainesville	Florida	32610-0224	—
Not listed	Jacksonville	Florida	32216	—
Not listed	Miami	Florida	33101	—
Not listed	Orlando	Florida	32804	—
Not listed	Tampa	Florida	33606	—
Not listed	Augusta	Georgia	30912	—
Not listed	Chicago	Illinois	60637	—
Not listed	Indianapolis	Indiana	46202-5124	—
Not listed	Wichita	Kansas	67214	—
Not listed	Lexington	Kentucky	40536-0293	—
Not listed	New Orleans	Louisiana	70121	—
Not listed	Shreveport	Louisiana	71130	—
Not listed	Baltimore	Maryland	21287-8611	—
Not listed	Boston	Massachusetts	02111	—
Not listed	Boston	Massachusetts	02215	—
Not listed	Burlington	Massachusetts	01805	—
Not listed	Springfield	Massachusetts	01107	—
Not listed	Worcester	Massachusetts	01655	—
Not listed	Ann Arbor	Michigan	48109-0362	—
Not listed	Detroit	Michigan	48202-2689	—
Not listed	Rochester	Minnesota	55905	—
Not listed	Hackensack	New Jersey	07601	—
Not listed	Livingston	New Jersey	07039	—
Not listed	Buffalo	New York	14203	—
Not listed	Hawthorne	New York	10532	—
Not listed	New York	New York	10021	—
Not listed	New York	New York	10029	—
Not listed	New York	New York	10032	—
Not listed	Rochester	New York	14642-8410	—
Not listed	The Bronx	New York	10467	—
Not listed	Chapel Hill	North Carolina	27599	—
Not listed	Winston-Salem	North Carolina	27157	—
Not listed	Fargo	North Dakota	58122	—
Not listed	Cleveland	Ohio	44106	—
Not listed	Portland	Oregon	97210	—
Not listed	Harrisburg	Pennsylvania	17101	—
Not listed	Hershey	Pennsylvania	17033	—
Not listed	Philadelphia	Pennsylvania	19102-1192	—
Not listed	Philadelphia	Pennsylvania	19104	—
Not listed	Philadelphia	Pennsylvania	19140	—
Not listed	Pittsburgh	Pennsylvania	15212	—
Not listed	Providence	Rhode Island	02903	—
Not listed	Dallas	Texas	75246	—
Not listed	San Antonio	Texas	78284	—
Not listed	Salt Lake City	Utah	84132	—
Not listed	Burlington	Vermont	05401	—
Not listed	Falls Church	Virginia	22042-3300	—
Not listed	Norfolk	Virginia	23502	—
Not listed	Seattle	Washington	98104	—
Not listed	Madison	Wisconsin	53792	—

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

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00087581, 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 Nov 7, 2016 · Synced Oct 23, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00087581 live on ClinicalTrials.gov.

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