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NCT00235300 · ClinicalTrials.gov registry record · Phase 2
An Open-label, Prospective, Randomized, Multi-center, Phase II Comparative Trial of Thymoglobulin Versus Simulect for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients.
A Phase 2 study of Cadaveric Donor Renal Transplantation and Acute Renal Allograft Rejection, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
- 20
- Study locations
NCT00235300 is a Phase 2 study of Cadaveric Donor Renal Transplantation and Acute Renal Allograft Rejection that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 240 participants. The trial reports 20 study locations across 15 states.
The verdict
NCT00235300, a Phase 2 study of Cadaveric Donor Renal Transplantation and Acute Renal Allograft Rejection, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
- 20
- Study locations
Study Summary
A multicenter clinical study comparing event-free survival at 6 months after transplant between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients. Patients received Thymoglobulin or Simulect from Day 0 through Day 4. Day 0 was considered the day of the transplant procedure. Subjects meeting all inclusion and exclusion criteria were eligible to participate in this study. The treatment assignment was random and not chosen by the subject or their physician. Subjects were monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurred up to 12 months after transplant. 278 study subjects were enrolled at 28 transplant centers in the United States and Europe.
Conditions Studied
Interventions
- BIOLOGICAL Thymoglobulin [Anti-thymocyte Globulin (rabbit)]
- DRUG Simulect (basliximab)
Study Locations (20)
Other
- Hopital Saint Jacques - Besançon
- Hopital de Bradois - Cedex
- Centre Hospitalier Universitaire - Grenoble
- Hopital Edouard Herriot - Lyon
California
- UCLA School of Medicine - Los Angeles
- California Pacific Medical Center - San Francisco
Georgia
- Emory University Hospital - Atlanta
- Medical College of Georgia - Augusta
Alabama
- University of Alabama - Birmingham
Connecticut
- Yale University School of Medicine - New Haven
Florida
- Florida Hospital Medical Center and Translife - Orlando
Illinois
- Rush University Transplant Program - Chicago
Kentucky
- University of Kentucky Medical Center - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2000-05 |
| Est. Completion | 2005-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00235300
The ClinicalTrials.gov registry entry for NCT00235300 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 240 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 196 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Cadaveric Donor Renal Transplantation appearing as the primary indexed condition, and to 2 interventions - of which Thymoglobulin [Anti-thymocyte Globulin (rabbit)] is the first listed.
NCT00235300 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT00235300 about?
NCT00235300 is a clinical study titled "An Open-label, Prospective, Randomized, Multi-center, Phase II Comparative Trial of Thymoglobulin Versus Simulect for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients.". A multicenter clinical study comparing event-free survival at 6 months after transplant between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients. Patients received Thymoglobulin or Simulect from Day 0 through Day 4. Day 0 was considered the day of the transplant procedure....
What is the current status of trial NCT00235300?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2000-05. Estimated completion is 2005-06.
What conditions does trial NCT00235300 study?
This clinical trial studies the following conditions: Cadaveric Donor Renal Transplantation, Acute Renal Allograft Rejection, Induction Therapy.
What interventions are being tested in trial NCT00235300?
The interventions under investigation include: Thymoglobulin [Anti-thymocyte Globulin (rabbit)] (BIOLOGICAL), Simulect (basliximab) (DRUG).
Who is sponsoring clinical trial NCT00235300?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00235300 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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