Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Open Label Randomized Study of Thymoglobulin Versus Daclizumab Induction Therapies for the Reduction of Acute Rejection in Live Donor Kidney Transplant Recipients With a Positive Crossmatch|
- 6-month acute cellular and antibody-mediated rejection rate
|Study Start Date:||January 2006|
|Estimated Study Completion Date:||January 2010|
Kidney transplantation is widely recognized as the optimal therapy for the management of end-stage renal disease. Presently, the deceased donor kidney waiting list has expanded disproportionately with the number of transplant procedures that are performed in the United States. To further compound this problem, as many as 1/3 of the patients on this list are highly sensitized against a broad range of potential donors.
In order to address this problem, we developed an antibody depletion protocol that permits transplantation in patients who have a positive crossmatch with their live donor. The protocol consists of standard immunosuppressant therapy, plasmapheresis, and intravenous immunoglobulin infusion. We have successfully performed transplantation in over 100 such patients with low complication rates.
Because these patients have been exposed to their donor's HLA antigen they are at high risk for both acute cellular and acute antibody-mediated rejection. This intent of this prospective, randomized, open-label trial is to determine whether induction therapy (i.e. therapy given at the time of transplantation for prophylaxis) with Thymoglobulin is associated with a lower 6-month incidence of acute cellular and antibody-mediated rejection than with our standard therapy, daclizumab.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00275509
|United States, Maryland|
|The Johns Hopkins University, School of Medicine|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Robert A Montgomery, M.D., Ph.D.||Johns Hopkins University , SOM|
|Study Director:||Christopher E Simpkins, M.D.||Johns Hopkins University, SOM|