Randomized controlled trial assessing the impact of everolimus and low-exposure tacrolimus on graft outcomes in kidney transplant recipients.
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 = .391), acute rejection rates (7% tacrolimus/mycophenolate vs 3% tacrolimus/everolimus, P = .554), and graft function (mean eGFR tacrolimus/mycophenolate 56 ± 15 vs tacrolimus/everolimus 59 ± 14 mL/min/1.73 m2 , P = .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.
['Taber|David J|DJ|0000-0001-7273-4589', 'Chokkalingam|Avudaiappan|A|', 'Su|Zemin|Z|', 'Self|Sally|S|', 'Miller|Dylan|D|', 'Srinivas|Titte|T|']
D000328:Adult D000068338:Everolimus D005260:Female D005500:Follow-Up Studies D005919:Glomerular Filtration Rate D006084:Graft Rejection D006085:Graft Survival D006801:Humans D007166:Immunosuppressive Agents D007676:Kidney Failure, Chronic D007677:Kidney Function Tests D016030:Kidney Transplantation D008297:Male D008875:Middle Aged D011183:Postoperative Complications D011379:Prognosis D011446:Prospective Studies D012307:Risk Factors D015996:Survival Rate D016559:Tacrolimus
everolimus tacrolimus kidney transplant acute rejection CMV infection BK infection