Envarsus XR in Lung Transplant

Pilot Study Comparing Early Conversion to Extended-Release Tacrolimus (ENVARSUS XR) to Immediate-Release Tacrolimus in Lung Transplant Recipients

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.

Lung transplantation will be performed per standard-of-care techniques. All post-transplant management, including initial triple immunosuppression, will be carried out per standard of care. Once the patient is able to take medications via the oral route, they will be converted to Envarsus XR, which will be maintained for the first year post-lung transplant.

Inclusion Criteria:

Prospective arm:

• Age ≥ 18 years
• Received a lung transplant at NYU Langone Health
• Be able to convert to Envarsus XR within the first month post-transplant
• Able and willing to provide informed consent

Historical control:

• Age ≥ 18 years
• Received a lung transplant at NYU Langone Health
• Completed one year from transplant on IR tacrolimus

Exclusion Criteria:

Prospective arm:

• Contraindication to tacrolimus due to allergic or adverse reactions
• Pregnant or nursing women
• Multi-organ transplant recipient

Historical control:

• Contraindication to tacrolimus due to allergic or adverse reactions (not including chronic kidney disease)