A Trial of Tolerogenic Immunosuppression in Highly Sensitized Renal Transplant Recipients
|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).
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|