Sirolimus in Kidney Transplantation: A Pilot Study in Chinese Patients

Abstract

We conducted a pilot open-label study on the use of sirolimus in 10 Chinese patients undergoing kidney transplantation who received triple prophylactic immunosuppression comprising prednisolone, cyclosporine and sirolimus. Sirolimus was given as a 6 mg loading dose followed by 2 mg/day maintenance. All patients achieved target sirolimus trough serum concentrations exceeding 5 ng/mL. Median duration of follow-up was 22 months after transplantation. One patient developed Type Ia acute cellular rejection at 6 months, which responded to pulse steroid therapy. Graft survival was 100% at 12 months and serum creatinine was 131 ± 36 μmol/L at 1 year. Low-density lipoprotein cholesterol and triglyceride levels were significantly increased after 2 months. Eight patients received atorvastatin, which was subsequently discontinued successfully in three patients. Infection was noted in two patients; one died of pneumocystis pneumonia 10 months after transplantation and the other had septicemia from urinary tract infection complicating graft vesicoureteric reflux. Two patients developed lymphocele in the early postoperative period, which resolved spontaneously in one patient and was treated successfully with ethanol sclerotherapy in the other. No patients developed thrombocytopenia or arthralgia. We conclude that sirolimus, when used together with prednisolone and cyclosporine, is well tolerated and effective in Chinese renal allograft recipients, and that hyperlipidemia early after transplantation is the most common adverse effect.