Envarsus XR in Lung Transplant

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study Comparing Early Conversion to Extended-Release Tacrolimus (ENVARSUS XR) to Immediate-Release Tacrolimus in Lung Transplant Recipients

Conditions
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Lung Transplant

Intervention / Treatment
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* Drug: Extended-Release Tacrolimus
* Drug: Immediate-Release Tacrolimus


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Envarsus XR<br>Envarsus XR to be initiated once patient is tolerating oral medications | Drug: Extended-Release Tacrolimus<br>* 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.<br>* Other names: Envarsus XR;|
| Experimental: IR tacrolimus (historical control)<br>Historical cohort of patients maintained on IR tacrolimus following transplant | Drug: Immediate-Release Tacrolimus<br>* 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.<br>* Other names: Prograf;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 Year Post-Transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from Acute Cellular Rejection (ACR) at 1 Year | Percentage of participants who did not experience ACR as of the 1-year follow-up. | 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. | 1 Year Post-Transplant | 
| Number of Treated Episodes of ACR |  | Up to 1 Year Post-Transplant | 
| Incidence of Chronic Lung Allograft Dysfunction (CLAD) | Number of instances of CLAD. | Up to 1 Year Post-Transplant | 
| Incidence of De Novo Donor-Specific Antibody (DSA) | Number of instances in which an antibody is detected within a participant only after transplantation. | Up to 1 Year Post-Transplant | 
| Change in Estimated Glomerular Filtration Rate (eGFR) |  | Baseline, 1 Year Post-Transplant | 
| Overall Survival at 1 Year | The percentage of participants who are alive at 1 year post-transplant. | 1 Year Post-Transplant |