Background: Sirolimus has been considered to be a non-nephrotoxic agent. It may delay graft function due to a potential hindrance of the recovery from acute tubular necrosis. It remains controversial as to whether the concomitant administration of sirolimus (SRL) with calcineurin inhibitors delays graft function in Asian patients.
Method: This study enrolled 61 patients who received primary renal transplantation. Twenty-one patients aged 38.9 +/- 11 years received early treatment with 6 mg/day sirolimus, 8 mg/kg/day cyclosporine (CsA) and prednisolone (SRL group). Forty patients with a mean age of 36.7 +/- 9 years in the control group were treated with the standard immunosuppressive therapy (8 mg/kg/day CsA, mycophonolate mofetil and prednisolone).
Results: The creatinine level at one week following transplantation in the SRL group was not significantly different from that in the control group (4.7 +/- 1.0 versus 2.7 +/- 0.4 mg/dL, p = 0.17). Similarly, there was no significant difference in the creatinine level at week 2 (3.4 +/- 0.7 versus 2.7 +/- 0.3 mg/dL, p = 0.36), week 3 (2.0 +/- 0.3 versus 2.1 +/- 0.2 mg/dL, p = 0.76), and week 4 (1.8 +/- 0.2 versus 1.8+/-0.1 mg/dL, p = 0.92) between SRL and control groups, respectively. Similarly, the number of the patients with renal function impairment in both groups was not significantly different. The one-year patient and graft survival was 100% and 96%, respectively, in the SRL group and 100% and 98%, respectively, in the control group.
Conclusion: The combination of sirolimus and cyclosporine did not prolong the recovery from transplantation-associated ischemic injury in kidney graft recipient. Our study demonstrated the safety of early usage of the concomitant administration of sirolimus and cyclosporine in kidney transplantation.