Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235300
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2005-10-06
Brief Title:
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
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None