Early conversion from calcineurin inhibitor to sirolimusto after renal transplantation:a prospective, open-label and non-randomized control study

Abstract

To explore the efficacy and safety of designed early conversion from calcineurin inhibitor (CNI) to sirolimus (SRL) as major immunosuppressive therapy in renal transplant recipients with stable renal function. A prospective, open-label and non-randomized control study was performed for 112 renal transplant recipients (3-6 months post-operation) with stable renal function between June 2008 and June 2011. The patients in SRL group (n = 57) switched to sirolimus while those in CNI group (n = 55) continued CNI. The dosing of mycophenolate mofetil and steroids had no change. They were followed up for at least 24 months to evaluate the acute rejection, patient and graft survival, renal function, estimated glomerular filtration rate (eGFR), blood lipids, blood glucose, liver function and urinary protein at 1, 6, 12 and 24 months after inclusion. Adverse events were also recorded. The serum creatinine of SRL group decreased significantly after conversion ( (89.2 ± 24.7), (87.6 ± 23.8), (86.1 ± 20.4), (86.7 ± 19.7) vs (117.0 ± 16.3) µmol/L, all P < 0.05). CNI group showed no improvement of renal function.SRL group had a significantly higher eGFR than CNI group (P < 0.05). Among 3 cases of acute rejection, there were 2 in SRL group and 1 in CNI group (P > 0.05). Blood lipids in SRL group increased significantly at 1 month after conversion (P < 0.05) and reverted back to average level after intervention (P > 0.05).SRL group had a drop of hemoglobin level within the normal range. Two patients in SRL group developed hypokalemia and another 2 patients had oral ulcer. They all improved after treatment. During follow-ups, 1 case of mild proteinuria was found in SIR group. Three patients were diagnosed with diabetes (1 in SRL group vs 2 in CNI group). Early conversion from CNI to SRL as major immunosuppressive therapy in renal transplant recipients with stable renal function further improves renal function. There is no higher rate of acute rejection during follow-up.Elevated blood lipids after conversion may be easily controlled. No other adverse events are found.