In a year-long study, Rapamune (sirolimus) was successfully used as a replacement for cyclosporine following kidney transplantation.
Results of the phase II, open-label randomized study were presented at Transplant 2001, the joint annual meeting of the American Society of Transplantation and the American Society of Transplant Surgeons. The study compared 97 patients who received Rapamune and cyclosporine and 100 patients who received Rapamune with cyclosporine that was eliminated three months after transplantation. After a year, there were no significant differences between the two groups in the rate of organ rejection and patient survival. However, renal function was significantly better in the patients whose cyclosporine use had been eliminated, according to a statement from Case Western Reserve University School of Medicine (http://mediswww.cwru.edu), one of 17 sites where the study was carried out.
"One of the disappointing paradoxes of kidney transplantation has always been that the standard therapy used to prevent kidney rejection can actually damage the new kidney, resulting in the need for a new transplant," said Donald E. Hricik, MD, lead investigator of the study at Case Western Reserve. "Rapamune offers a solution to that paradox by maintaining healthy kidney function while preventing organ rejection."
Wyeth-Ayerst Laboratories, which manufacturers and markets Rapamune, provided funding for the study.
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