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Completed Phase 2 Interventional

A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection

ClinicalTrials.gov ID: NCT00089947

Public ClinicalTrials.gov record NCT00089947. 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 Oct 21, 2026, 4:06 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

Randomized, Prospective, Phase 2 Study Comparing Thymoglobulin in a Rapid Discontinuation of Corticosteroids Protocol With Standard Corticosteroid Therapy in Living Donor Renal Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy

Brief summary

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

This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant rejection. This study will evaluate the effect of Thymoglobulin and reduced doses of steroids to prevent renal transplant rejection and will provide a basis for future evaluations of Thymoglobulin as an immunosuppressive agent to help prevent renal transplant rejection. Subjects meeting all inclusion and exclusion criteria are eligible to participate in this study. In addition to standard treatment, study participants will receive either Thymoglobulin with rapid discontinuation of steroids or steroids per hospital standards for at least the first 90 days after transplant. The treatment assignment is random and is not chosen by the subject or their physician. Subjects will be monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurs at Months 1, 3, 6 and 12 following the transplant. Approximately 150 study subjects from 15-20 transplant centers in the United States will be enrolled.

Study identification

NCT ID
NCT00089947
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Genzyme, a Sanofi Company
Industry
Enrollment
150 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
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 2003 (Type not available)
Primary completion
Dec 2005 (Actual)
Completion
Dec 2005 (Actual)
Last update posted
Mar 18, 2015

2003 – 2005

United States locations

U.S. sites
19
U.S. states
14
U.S. cities
16
Facility City State ZIP Site status
University of Arkansas for Medical Science Little Rock Arkansas 72205 —
Keck USC School of Medicine Los Angeles California 90033 —
University of California, Los Angeles Medical Center Los Angeles California 90095 —
University of California, San Diego Medical Center San Diego California 92103 —
California Pacific Medical Center San Francisco California 94115 —
University of California, San Francisco San Francisco California 94143 —
University of Colorado Health Sciences Center Denver Colorado 80262 —
Emory University Atlanta Georgia 30322 —
Indiana University Indianapolis Indiana 46202 —
Oschner Medical Center New Orleans Louisiana 70121 —
Johns Hopkins University Hospital Baltimore Maryland 21287 —
Saint Barnabas Medical Center Livingston New Jersey 07039 —
Mount Sinai School of Medicine New York New York 10029 —
Duke University Medical Center Durham North Carolina 27710 —
Christ Hospital Cincinnati Ohio 45219 —
University of Cincinnati Medical Center Cincinnati Ohio 45267 —
Texas Transplant Institute San Antonio Texas 78229 —
Medical College of Virginia Richmond Virginia 23298 —
Medical College of Wisconsin Milwaukee Wisconsin 53226 —

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 NCT00089947, 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 Mar 18, 2015 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00089947 live on ClinicalTrials.gov.

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