Renal Function Outcomes with Envarsus® versus Prograf®

Philadelphia—In the first year following kidney transplantation, two formulations of tacrolimus are associated with good renal function, according to results of a study conducted by Lionel Rostaing, MD, PhD, and colleagues. Study results were reported during a poster session at Kidney Week 2014 in a poster titled Renal Function Outcomes Associated with Once-Daily MeltDose® Tacrolimus versus Twice-Daily Tacrolimus, a Phase 3 Randomized Trial in De Novo Kidney Transplantation.

Previous studies demonstrated greater bioavailability, noninferior efficacy, and similar safety and lower total daily dose associated with conversion of stable kidney transplant recipients from twice-daily tacrolimus (Prograf®) to a novel, once-daily Meltdose® formulation of tacrolimus (Envarsus®; LCP-Tacro).

The current phase 3, double-blind, doubledummy trial was designed to examine renal function results in a population of de novo kidney transplant recipients randomized to Envarsus or Prograf. The study population included 543 kidney transplant recipients; 268 were randomized to receive Envarsus and 275 to receive Prograf

Assessment of renal function was conducted via the Modification of Diet in Renal Disease-7 formula. Delayed graft function was clinician-reported as an adverse event or a serious adverse event. The Kidney Week 2014 poster reported 12-month follow-up estimated glomerular filtration rate (eGFR) data; 2-year data are forthcoming.

Target trough levels were achieved earlier for the patients receiving Envarsus versus Prograf: within 1 day of first dose, 66% of Envarsus patients versus 25% of Prograf achieved troughs of ≥6 ng/mL (P<.001). Total daily dose and troughs were higher for Envarsus in the first 2 weeks; over the course of the study, the cumulative dose of Envarsus was 14% lower than Prograf.

The incidence of delayed graft function tended to be lower for Envarsus than for Prograf (7% vs 11%, respectively). Both Envarsus and Prograf were associated with good renal function over the first 12 months of the study.

In conclusion, the researchers said, “These results show that both tacrolimus formulations are associated with good renal function in the first year post-transplant. A higher initial Envarsus total daily dose was not associated with renal function decrement, either in terms of eGFR of delayed graft failure.”