Induction Therapy Clinical Trial
Official title:
An Open-Label Prospective, Randomized, Multicenter 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.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05385432 -
Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies
|
Phase 3 | |
| Recruiting |
NCT05832320 -
Optimum Induction Therapy of Low-risk APL
|
N/A |