Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT01038505
Status:
WITHDRAWN
Last Update Posted:
2024-06-03
First Post:
2009-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Tacrolimus and Myfortic Versus Tacrolimus and Sirolimus
Sponsor:
University of Miami
Organization:
Study Overview
Official Title:
Head to Head Comparison of Tacrolimus and Myfortic vs Tacrolimus and Sirolimus Used in Combination in Non-HLA Identical Living Donor Kidney Transplants
Status:
WITHDRAWN
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lost funding source
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators center has also analyzed data over the last 7 years from deceased donor (DD) and living donor (LD) kidney transplant recipients who were randomized into 3 immunosuppressive arms between 2000 and 2001. Thus the goal of the investigators study is to reduce the toxic effects of traditional immunosuppressive regimens involving high-dose calcineurin inhibitor agents by comparing low-dose TAC-MYF with low-dose TAC and de novo SRL regimens. In order to minimize exposure to TAC, the investigators center has previously shown favorable outcomes using combination Thymoglobulin and Zenapax (Daclizumab) for anti-lymphocyte induction in the investigator population of patients.
Detailed Description:
A total of 150 randomized patients divided into 2 arms: 75 patients will be randomized to receive TAC-SRL, and 75 patients to receive TAC-MYF.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: