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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.
Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
NYU Langone Health
New York, New York, United States
Percentage of Patients Remaining on Envarsus XR at 1 Year
The primary endpoint is the percentage of patients remaining on Envarsus XR at the 1-year follow-up visit.
Time frame: 1 Year Post-Transplant
Freedom From Acute Cellular Rejection (ACR) at 1 Year
Number of participants who did not experience ACR as of the 1-year follow-up.
Time frame: Up to 1 Year Post-Transplant
Composite Rejection Standardized Score (CRSS)
The CRSS is a novel measure of burden of ACR. The score ranges from 0-6; higher scores indicate greater severity of burden of ACR.
Time frame: 1 Year Post-Transplant
Number of Treated Episodes of ACR
Number of participants with treated episodes of biopsy-proven or clinically suspected rejection requiring treatment with intravenous methylprednisolone or anti-thymocyte globulin.
Time frame: Up to 1 Year Post-Transplant
Number of Participants With of Chronic Lung Allograft Dysfunction (CLAD)
Number of participants with at least 1 instance of CLAD.
Time frame: Up to 1 Year Post-Transplant
Number of Participants With De Novo Donor-Specific Antibody (DSA)
Number of individuals in whom an antibody is detected after transplantation.
Time frame: Up to 1 Year Post-Transplant
Change in Estimated Glomerular Filtration Rate (eGFR)
Change in Estimated Glomerular Filtration Rate (eGFR) at 1 year post-transplant from pre-transplant.
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Time frame: Baseline, 1 Year Post-Transplant
Overall Survival at 1 Year
The percentage of participants who are alive at 1 year post-transplant.
Time frame: 1 Year Post-Transplant