Status:
COMPLETED
Envarsus XR in Lung Transplant
Lead Sponsor:
NYU Langone Health
Conditions:
Lung Transplant
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 patie...
Detailed 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 p...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04420195
Start Date
October 23 2020
End Date
November 30 2022
Last Update
January 22 2024
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016