NCT00235300

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.

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Cadaveric Donor Renal Transplantation
• Acute Renal Allograft Rejection
• Induction Therapy

Interventions

Type	Name	Description
BIOLOGICAL	Thymoglobulin [Anti-thymocyte Globulin (rabbit)]	1.5 mg/kg per day, for a maximum of 5 doses
DRUG	Simulect (basliximab)	20 mg per day on 2 days

Timeline

• Start date: 2000-05-01
• Primary completion: 2003-04-01
• Completion: 2005-06-01
• First posted: 2005-10-10
• Last updated: 2015-03-18

Locations

28 sites across 5 countries: United States, France, Germany, Spain, United Kingdom