Early conversion of pediatric kidney transplant patients to everolimus with reduced tacrolimus and steroid elimination: Results of a randomized trial.Tonshoff B, Ettenger R, et al.
Am J Transplant. 2018; [record in progress].
A 12-month study to evaluate the efficacy of early conversion to everolimus with reduced tacrolimus and steroid elimination in pediatric kidney transplant patients.
Patients randomized at 4 to 6 weeks posttransplant to continue a regimen of standard‐dose tacrolimus therapy with mycophenolate mofetil (sTAC/MMF) and steroids or switch to everolimus with reduced dose tacrolimus (EVR/rTAC) and steroid elimination, with steroid tapering planned to start at Month 5 post transplant.
106 patients were randomized and formed the ITT and safety populations (EVR/rTAC, n = 52; sTAC/MMF, n = 54). In total, 103 of 106 patients (97.2%) completed the 12‐month study.
Co‐primary efficacy end points were composite efficacy failure end point (BPAR, graft loss, or death) from randomization to Month 12 and renal function as assessed by eGFR at Month 12. Secondary efficacy end points included the incidence, timing and severity of BPAR; the incidence of steroid‐resistant BPAR and antibody‐mediated BPAR, graft loss, and death.
This multicentre, open-label study investigated a switch to everolimus, low dose tacrolimus and steroid withdrawal in paediatric renal transplant recipients at 4-6 weeks post-op. At 12-month follow-up, outcomes were equivalent to a control group continuing a standard-dose tacrolimus, MMF and steroid regimen. The only significant difference was the rate of adverse events, with 35% those randomized to everolimus discontinuing this by Month 12. These results suggest that this regimen offers a safe and viable alternative to standard immunosuppression in a low-risk paediatric population. It should be noted that recipients with a PRA >20%, and those receiving a kidney from a donor over 60 years of age were excluded, so higher-risk transplants may not demonstrate the same outcomes. It is possible with longer-term follow-up that steroid avoidance may improve development and growth, although no difference was seen during the short follow-up period in the present study.
ClinicalTrials.gov - NCT01544491