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NCT00089947 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection
A Phase 2 study of Renal Transplantation and Graft Rejection, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 19
- Study locations
NCT00089947 is a Phase 2 study of Renal Transplantation and Graft Rejection that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 150 participants, above the 30-participant average among 7 other Renal Transplantation trials with a reported enrollment target (400% higher). The trial reports 19 study locations across 14 states.
The verdict
NCT00089947, a Phase 2 study of Renal Transplantation and Graft Rejection, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 19
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 30-participant average among 7 other Renal Transplantation trials with a reported enrollment target (400% higher). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
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.
NCT00089947 reports 19 study locations spanning 14 distinct geographic areas - top geographies include California, Ohio, Arkansas.
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.
What interventions are being tested in trial NCT00089947?
The interventions under investigation include: Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] (DRUG).
Who is sponsoring clinical trial NCT00089947?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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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