Ignite Creation Date:
2024-05-06 @ 9:51 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03099122
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2017-03-29
Brief Title:
A Study of Thymoglobuline Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Prospective Multi-center Single-arm Interventional Study of Thymoglobuline Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant in China
Status:
COMPLETED
Status Verified Date:
2022-04
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:
START-DCD
Brief Summary:
Primary Objective
To investigate the efficacy of the standard dose of Thymoglobuline induction therapy for preventing acute rejection AR after transplantation among recipients of Donated after Cardiac Death DCD kidney transplant
Secondary Objectives
To evaluate delayed graft function DGF graft and patient survival after kidney transplant
To evaluate adverse events of Thymoglobuline throughout the study
To explore possible risk factors of AR and DGF in patients with DCD kidney transplant
To evaluate AR and DGF under different risk stratifications and explore an description optimal induction therapy regimen for recipients of DCD kidney transplant
To investigate the efficacy of the standard dose of Thymoglobuline induction therapy for preventing acute rejection AR after transplantation among recipients of Donated after Cardiac Death DCD kidney transplant
Secondary Objectives
To evaluate delayed graft function DGF graft and patient survival after kidney transplant
To evaluate adverse events of Thymoglobuline throughout the study
To explore possible risk factors of AR and DGF in patients with DCD kidney transplant
To evaluate AR and DGF under different risk stratifications and explore an description optimal induction therapy regimen for recipients of DCD kidney transplant
Detailed Description:
The total study duration per patient is 65 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1178-5402 | OTHER | UTN | None |