A Phase 2 Randomized Study of Maraviroc to Prevent Primary Graft Dysfunction in Adults Undergoing Bilateral Lung Transplantation

What this Trial Is About

Lung transplant recipients face a high risk of primary graft dysfunction PGD, a serious early complication that contributes to lower survival compared to other organ transplants. PGD is caused by the bodys innate immune response, particularly involving Natural Killer NK cells, and currently has no approved treatments. This trial evaluates Maraviroc, an FDA-approved drug known to inhibit these immune cells, to see if it can prevent or treat PGD in adult lung transplant patients with a high risk score. Participants will be randomly assigned to receive either Maraviroc or a placebo in a double-blind design. Maraviroc is given orally or via feeding tube at 300 mg just before surgery, then every 12 hours for a total of 7 doses over 3 days post-transplant, with the first three doses at 300 mg and the remaining four at 150 mg. The placebo matches Maraviroc in appearance and dosing schedule. The study includes an initial hospital stay period of up to 28 days around the transplant surgery and a follow-up visit at 12 months after discharge. During the study, participants will undergo regular physical exams, blood tests, and bronchoscopy procedures to collect samples from the lungs for biological analysis. Safety and drug levels will be closely monitored, and data will be securely stored and reviewed by an independent monitoring board. The primary outcome measured is the incidence of severe PGD within 3 days after transplant, with secondary outcomes including lung function and biological markers assessed up to 12 months. Participants safety and well-being will be continuously assessed throughout the trial and follow-up period.

This Study is Assessing the Safety and Efficacy of Immune Inhibition as a Treatment to Prevent Primary Graft Dysfunction