Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00407160
Status:
COMPLETED
Last Update Posted:
2019-03-04
First Post:
2006-11-21
Brief Title:
A Trial of Tolerogenic Immunosuppression in Highly Sensitized Renal Transplant Recipients
Sponsor:
The University of Texas Medical Branch Galveston
Organization:
The University of Texas Medical Branch Galveston
Study Overview
Official Title:
Comparison of Two Different Immunosuppression Protocols in Highly Sensitized Renal Transplant Recipients Campath Induction With Tacrolimus Monotherapy vs Thymoglobulin Induction With Triple Drug Protocol
Status:
COMPLETED
Status Verified Date:
2012-12
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:
Comparison between Campath induction and monotherapy with Tacrolimus vs Thymoglobulin induction and triple drug maintenance using Tacrolimus mycophenolate and steroids
Detailed Description:
Recent reports suggest that it might be possible to induce a state of tolerance in solid organ transplantation So called tolerogenic immunosuppression involves induction with lymphocyte depleting antibodies followed by monotherapy with calcineurin inhibitors cyclosporin or tacrolimus The proposed study aims to evaluate a protocol of immunosuppression induction with lymphocyte depleting antibody Campath given prior to graft reperfusion followed by tacrolimus monotherapy in highly sensitized patients PRA 14 or past historical 50 andor multiple renal transplants undergoing renal transplantation and compare it with the current standard protocol at UTMB which employs induction with Thymoglobulin given over 4 days followed by 3 drugs tacrolimus mycophenolate and steroids In both groups of patients the target tacrolimus levels will be the same ie between 10 to 15ngmL soon after the transplant In the Campath gro up tacrolimus will be tapered after 3 months in patients who do not have rejection and appear to be developing donor specific tolerance
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