Previous studies reported that tacrolimus (TAC) with high-dose sirolimus (SRL) was associated with worse outcomes in kidney transplantation, compared to TAC with mycophenolate mofetil (MMF.). However, outcomes using low-dose SRL with TAC are uncertain. We aimed to assess the efficacy and safety of low-dose SRL with extended-release tacrolimus (ER-TAC) versusMMF with ER-TAC.

We randomly assigned 158 renal transplant patients to receive low-dose SRL or MMF in combination with ER-TAC and corticosteroid. The primary endpoint was the composite efficacy failure rate, including biopsy-proven acute rejection (BPAR), graft loss, death, or loss to follow-up, within 12 months post-transplantation.

The efficacy failure rate was 6.6% in the low-dose SRL group and 13.3% in the MMF group in the intention-to-treat population (absolute difference, 6.8%; 95% CI -2.8 to 16.3%). The incidence of BPAR within 12 months post-transplantation was 5.3% in the low-dose SRL group and 13.3% in the MMF group (p=0.09). The mean estimated glomerular filtration rate, the incidences of adverse events and serious adverse events were similar between groups. Low-dose SRL with ER-TAC was not inferior to MMF with ER-TAC with respect to efficacy and safety. Low-dose SRL with ER-TAC can effectively prevent acute rejection and preserve renal function. (ClinicalTrial.gov number, NCT01680952.)

CITATION INFORMATION: Lee J, Huh K, Ha J, Oh C.-K, Ju M, Kim C.-D, Cho H, Jung C, Lim B, Kim Y. De Novo Low-Dose Sirolimus versus Mycophenolate Mofetil in Combination with Extended-Release Tacrolimus in Kidney Transplant Recipients. Am J Transplant. 2017;17 (suppl 3).

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