Envarsus XR in Lung Transplant

NCT04420195 ↗

Phase 2 Completed 41 enrolled NYU Langone Health

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Patients undergoing a lung transplant will be enrolled. All patients will undergo lung transplantation with standard post-operative management, including triple immunosuppression. As soon as the patient is deemed appropriate to take medications via the oral route, they will be converted from IR tacrolimus to Envarsus XR. Patients will be followed per site's standard of care.

Timeline

Start: 2020-10-23
Primary completion: 2022-11-30
Completion: 2022-11-30

Publications

Lewis TC, Hotchkis P, Wong A, Lamaina V, Fitzpatrick E, Stiefel A, Ohanian J, Schnier JR, Lesko M, Rudym D, Natalini JG, Angel LF. Comparison of Early Conversion to LCP-Tacrolimus (ENVARSUS XR) to Immediate-Release Tacrolimus in Lung Transplant Recipients. Clin Transplant. 2025 May;39(5):e70159. doi: 10.1111/ctr.70159.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tacrolimus	Small molecule	—	Oral

Indications

No indication recorded.