Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection
NCT00089947 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]
Study Locations (19)
California
- Keck USC School of Medicine — Los Angeles
- University of California, Los Angeles Medical Center — Los Angeles
- University of California, San Diego Medical Center — San Diego
- California Pacific Medical Center — San Francisco
- University of California, San Francisco — San Francisco
Ohio
- Christ Hospital — Cincinnati
- University of Cincinnati Medical Center — Cincinnati
Arkansas
- University of Arkansas for Medical Science — Little Rock
Colorado
- University of Colorado Health Sciences Center — Denver
Georgia
- Emory University — Atlanta
Indiana
- Indiana University — Indianapolis
Louisiana
- Oschner Medical Center — New Orleans
Maryland
- Johns Hopkins University Hospital — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2003-06 |
| Est. Completion | 2005-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00089947
The ClinicalTrials.gov registry entry for NCT00089947 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Renal Transplantation appearing as the primary indexed condition, and to 1 intervention — of which Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00089947 reports 19 study locations spanning 14 distinct geographic areas — top geographies include California, Ohio, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00089947 about?
NCT00089947 is a clinical study titled "A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection". 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 transpl...
What is the current status of trial NCT00089947?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2003-06. Estimated completion is 2005-12.
What conditions does trial NCT00089947 study?
This clinical trial studies the following conditions: Renal Transplantation, Graft Rejection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00089947?
The interventions under investigation include: Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00089947?
This trial is sponsored by Genzyme, a Sanofi Company, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00089947 being conducted?
This trial has 19 study locations across Arkansas, California, Colorado, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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