Envarsus XR in Lung Transplant

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NYU Langone Health
• Treatments: Tacrolimus

Criteria

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)