A Trial of Tolerogenic Immunosuppression in Highly Sensitized Renal Transplant Recipients
Comparison between Campath induction and monotherapy with Tacrolimus vs Thymoglobulin induction and triple drug maintenance using Tacrolimus, mycophenolate, and steroids.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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.|
|Study Start Date:||August 2004|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Patients with ESRD and high PRA who randomise to the control group. These patients will get induction therapy prior to transplant with Thymoglobulin 1.5 mg/kg/day for 4 days to a total dose of 6mg/kg.
They will receive maintenance immunosuppression with three drugs : tacrolimus, cellcept and prednisone.
Patients with ESRD and high PRA who randomise to the study group. These patients will get induction therapy prior to reperfusion of the kidney, during the transplant operation, with Campath (Alemtuzumab) 30mg, one dose. They will receive maintenance immunosuppression with tacrolimus alone (monotherapy).
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% and/or 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 i.e, between 10 to 15ng/mL, 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407160
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555-0533|
|Principal Investigator:||Philip G Thomas, MD||UTMB Department of Surgery|