Randomized Controlled Trial Assessing the Impact of Everolimus and Low Exposure Tacrolimus on Graft Outcomes in Kidney Transplant Recipients.

Abstract

This was a single-center, randomized controlled trial assessing the impact of a 3-month (10-16 weeks) conversion to everolimus with low exposure tacrolimus, as compared to remaining on full exposure tacrolimus with mycophenolate (NCT02096107). Adult, kidney transplant recipients with a functioning graft were eligible for participation. Goal troughs in the intervention arm were 2-5 ng/mL for tacrolimus and 3-8 ng/mL for everolimus, with tacrolimus maintained at 5-12 ng/mL in the control arm; 60 were randomized (30 in each arm) and were well matched at baseline; mean age was 51 years and 57% were African-American. At 12-months, fibrosis scores (27.8% tacrolimus/mycophenolate vs. 22.9% tacrolimus /everolimus, p=0.391), acute rejection rates (7% tacrolimus /mycophenolate vs. 3% tacrolimus /everolimus, p=0.554) and graft function (mean eGFR tacrolimus /mycophenolate 56±15 vs tacrolimus /everolimus 59±14 mL/min/1.73 m , p=0.465) were similar between arms. The everolimus arm had significantly lower rates of CMV infection, severe BK infection and improved BK viral clearance kinetics, as compared to the MPA arm. In this population, including a significant number of African-Americans, an immunosuppression regimen of everolimus with low exposure tacrolimus provided similar efficacy to tacrolimus and mycophenolate, with significantly lower rates of BK and CMV.