Calendario›SNY›Thymoglobulin [Anti-thymocyte…
Thymoglobulin [Anti-thymocyte…
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.
Ensayo de Sanofi en Cadaveric Donor Renal Transplantation · Acute Renal Allograft Rejection · Induction Therapy (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 240
- Centros
- 28
- Fin del objetivo primario
- abr 2003
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en may 2000.
Qué mide
Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant. (del registro, en inglés) (6 meses)
Cómo lo describe el promotor
En el documentoEn inglés, del registroA 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.
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Ficha completa en ClinicalTrials.gov (NCT00235300), actualizada en mar 2015.