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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.
NCT00235300 · View on ClinicalTrials.gov ↗
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 |
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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. 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 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 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 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. 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: NCT00235300 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, California, Georgia. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00235300?
The interventions under investigation include: Thymoglobulin [Anti-thymocyte Globulin (rabbit)] (BIOLOGICAL), Simulect (basliximab) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00235300?
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 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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