Kidney Transplant Failure and Rejection Clinical Trial
Official title:
A Phase IV, Single Center Pilot Study Using Alemtuzumab (Campath-1H) Induction Combined With Prednisone-Free, Calcineurin-Inhibitor-Free Immunosuppression in Kidney Transplantation
This is an open label, single-center, randomized phase IV pilot study of steroid and
calcineurin inhibitor avoidance in renal transplant recipients. All patients will receive
two doses of alemtuzumab to achieve peripheral T-cell depletion. Intravenous glucocorticoids
will be administered prior to alemtuzumab administration to limit cytokine release syndrome
in association with this monoclonal antibody, and continued for the first two days
post-transplant. Thereafter, steroids will not be used for immunosuppression. All transplant
recipients will be started on oral immunosuppressive therapy with mycophenolate mofetil
(MMF) prior to transplant. Pretransplant, these patients will be randomized to receive, in
addition, either tacrolimus (Tac) or sirolimus.
After six months, patients in the tacrolimus arm who do not experience rejection will be
randomized to continue on tacrolimus or to be converted to the combination of sirolimus and
MMF. Individuals in this arm of the study who do not experience acute rejection, and
demonstrate evidence of donor specific hyporesponsiveness at 9 months post-transplant (those
staying on Tac + MMF) or 3 months post-conversion (those converted from Tac + MMF to
sirolimus + MMF) will be weaned to MMF monotherapy.
Individuals in the sirolimus + MMF arm who do not experience acute rejection and demonstrate
evidence of donor specific hyporesponsiveness at 6 months post-transplant will be weaned to
MMF monotherapy.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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