Kidney Failure, Chronic Clinical Trial
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
The purpose of this study is to determine whether the anti-T cell antibody, Thymoglobulin is a more effective induction medication than the anti-IL-2R inhibitor daclizumab, in kidney transplant recipients who have a positive crossmatch with their live donor.
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 human leukocyte antigen (HLA) 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.
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