Pilot Study Comparing Early Conversion to Extended-Release Tacrolimus (ENVARSUS XR) to Immediate-Release Tacrolimus in Lung Transplant Recipients
Overview
- Phase
- Phase 2
- Intervention
- Extended-Release Tacrolimus
- Conditions
- Lung Transplant
- Sponsor
- NYU Langone Health
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Percentage of Patients Remaining on Envarsus XR at 1 Year
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 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.
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 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.
Investigators
Eligibility 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)
Arms & Interventions
Envarsus XR
Envarsus XR to be initiated once patient is tolerating oral medications
Intervention: Extended-Release Tacrolimus
IR tacrolimus (historical control)
Historical cohort of patients maintained on IR tacrolimus following transplant
Intervention: Immediate-Release Tacrolimus
Outcomes
Primary Outcomes
Percentage of Patients Remaining on Envarsus XR at 1 Year
Time Frame: 1 Year Post-Transplant
The primary endpoint is the percentage of patients remaining on Envarsus XR at the 1-year follow-up visit.
Secondary Outcomes
- Freedom From Acute Cellular Rejection (ACR) at 1 Year(Up to 1 Year Post-Transplant)
- Composite Rejection Standardized Score (CRSS)(1 Year Post-Transplant)
- Number of Treated Episodes of ACR(Up to 1 Year Post-Transplant)
- Number of Participants With of Chronic Lung Allograft Dysfunction (CLAD)(Up to 1 Year Post-Transplant)
- Number of Participants With De Novo Donor-Specific Antibody (DSA)(Up to 1 Year Post-Transplant)
- Change in Estimated Glomerular Filtration Rate (eGFR)(Baseline, 1 Year Post-Transplant)
- Overall Survival at 1 Year(1 Year Post-Transplant)