Clinical study ofsirolimus plus low-dose calcineurin inhibitor after kidney transplantation from expanded criteria donors

Objective To explore the efficacy and safety of converting from traditional calcineurin inhibitor-based immunosuppressive regimen to sirolimus plus low-dose calcineurin inhibitor after kidney transplantation from expanded criteria donors. Methods For this prospective, open-label, non-randomized controlled clinical trial, 15 recipients of initial transplant from expanded criteria donors received sirolimus plus low-dose calcineurin inhibitor regimen 3 months after transplantation during June 2017 and March 2018. The follow-up period was over 1 year. The allograft survival time, changes in blood creatinine and glomerular filtration rate before and after conversion (0, 1, 3, 6, 12 months), changes in urinary protein before and after conversion, incidence of acute rejection after conversion, BK virus or cytomegalovirus infection and sirolimus-related complications were observed. Results Renal functions of all 15 patients improved after conversion and 1-year allograft survival rate was 100% (15/15). Serum creatinine decreased markedly and glomerular filtration rate increased significantly at 1 month and 3 months after conversion (P<0.05). BK viruria was detected in 5 patients before conversion. After conversion, BK virus turned into negative in 3 patients within 3 months and viral load also decreased in another 2 patients. After conversion, only 2 patients (13.3%) developed de novo proteinuria. Eight patients (53.3%) developed de novo hypertriglyceridemia responding well to medications. None of them experienced acute rejection during follow-ups. Conclusions Sirolimus plus low-dose calcineurin inhibitor is a safe and effective maintenance immunosuppressive regimen for recipients of kidneys from expanded criteria donors, especially for those with abnormal renal function during recovery. But it cannot completely replace the traditional immunosuppressive regimen. Individualized treatment should be chosen properly for recipients. Key words: Kidney transplantation; Sirolimus; Calcineurin inhibitor