Kidney Biopsy Controlled Trial of Calcineurin Inhibitor Withdrawal
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
Current therapy to prevent organ rejection relies on the use of calcineurin inhibitors either
cyclosporine or tacrolimus. Although these agents have been very successful in preventing
early acute rejection, this success has not translated into improved long-term kidney
transplant function. One of the important factors that leads to premature kidney transplant
failure is chronic allograft nephropathy (CAN). CAN is characterized by progressive
interstitial fibrosis or "scarring", vascular wall thickening, and finally glomerular
sclerosis leading to slow progressive loss of kidney function. Calcineurin inhibitors have
been shown to play an important role in the pathogens of CAN. Renal transplant recipients in
whom calcineurin inhibitors are discontinued enjoy better and longer kidney function.
Therefore, immunosuppressive strategies are being designed with the intention of withdrawing
calcineurin inhibitors.
The purpose of this trial is to test if tacrolimus can be safely substituted by sirolimus
(Rapamycin) and this substitution will yield improved renal function, less CAN and better
graft survival rates over the first year.