Objectives: The long-term use of cyclosporine always contributes to chronic renal allograft dysfunction. Converting from cyclosporine to sirolimus and reducing cyclosporine dosage under high mycophenolate mofetil levels are 2 common therapies. Their efficacy and safety have not been compared in Chinese patients.
Materials and methods: In this prospective, open label, randomized study, 51 kidney recipients with an estimated glomerular filtration rate between 30 and 60 mL/min/1.73 m² were enrolled. Patients in the sirolimus group (n=22) initiated sirolimus 12 hours after cessation of cyclosporine. Patients in the cyclosporine group (n=29) significantly reduced cyclosporine dosage under high mycophenolate mofetil dosages. Both groups were followed-up for 4 years.
Results: The baseline estimated glomerular filtration rate was 36.46 ± 6.22 mL/min/1.73 m² in sirolimus group and 36.07 ± 6.18 mL/min/1.73 m² in the cyclosporine group (P = NS). In cyclosporine group, the estimated glomerular filtration rate declined significantly at 12, 18, 24, 30, 36, 42, and 48 months after inclusion compared with baseline, and was lower than the sirolimus group at 30, 36, 42, and 48 months after inclusion (P < .05). As for the endpoints of graft loss and return to dialysis, the 4-year graft survival was 77.3% in the sirolimus group and 55.2% in the cyclosporine group (P = NS). As for the endpoint of serum creatinine doubling, 4-year survival was 77.3% in the sirolimus group and 41.4% in the cyclosporine group (P < .05). Three patients in sirolimus group (2 acute rejections, 1 pneumonia) and 2 patients in the cyclosporine group (owing to acute rejection) dropped out (P = NS).
Conclusions: Conversion from cyclosporine to sirolimus could improve long-term survival of renal grafts in Chinese patients.