Envarsus XR in Lung Transplant

NYU Langone Health

Status and phase: Completed; Phase 2

Conditions: Lung Transplant

Treatments: Drug: Immediate-Release Tacrolimus; Drug: Extended-Release Tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT04420195

19-01247

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

41 participants in 2 patient groups

Envarsus XR

Experimental group

Description:

Envarsus XR to be initiated once patient is tolerating oral medications

Treatment:

Drug: Extended-Release Tacrolimus

IR tacrolimus (historical control)

Experimental group

Description:

Historical cohort of patients maintained on IR tacrolimus following transplant

Treatment:

Drug: Immediate-Release Tacrolimus