Early Use of Long-Acting Tacrolimus Envarsus XR Compared to Standard Tacrolimus in Adults After Lung Transplant

What this Trial Is About

This research aims to evaluate the early use of long-acting tacrolimus LCP-tacrolimus compared to intermediate-release tacrolimus IR-tacrolimus in lung transplant recipients. Lung transplantation requires lifelong immunosuppressive treatment to prevent rejection, but current drugs like tacrolimus can cause serious side effects including kidney damage, infections, and neurological issues. The study focuses on whether using LCP-tacrolimus soon after transplant can be safe and better tolerated while preserving kidney function. Participants will be randomly assigned to receive daily LCP-tacrolimus or twice-daily IR-tacrolimus for seven months, both targeting specific blood trough levels. Additional immunosuppressants such as mycophenolate mofetil or azathioprine, along with prednisone, will be given in both groups. The study will evaluate treatment safety, tolerability, and side effects during this period. During the trial, participants will have regular assessments including kidney function tests, monitoring for rejection episodes, evaluation of headaches and tremors, and quality of life related to side effects. Researchers will observe for antibody development and monitor safety for up to nine months post-transplant. The study participation involves close medical follow-up to measure these outcomes and ensure patient well-being.

Early Use of Long-acting Tacrolimus in Lung Transplant Recipients