Envarsus XR in Lung Transplant

Phase 2

Completed

• Conditions: Lung Transplant
• Interventions: Drug: Extended-Release Tacrolimus; Drug: Immediate-Release Tacrolimus

• Registration Number: NCT04420195
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2020-10-23
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Results First Submitted: 2023-11-30
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-18
• Last Update Submitted: 2024-01-18
• Results First Posted: 2024-01-22
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Envarsus XR	Extended-Release Tacrolimus	Envarsus XR to be initiated once patient is tolerating oral medications
IR tacrolimus (historical control)	Immediate-Release Tacrolimus	Historical cohort of patients maintained on IR tacrolimus following transplant

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Remaining on Envarsus XR at 1 Year	1 Year Post-Transplant	The primary endpoint is the percentage of patients remaining on Envarsus XR at the 1-year follow-up visit.

Secondary Outcome Measures

Name	Time	Method
Freedom From Acute Cellular Rejection (ACR) at 1 Year	Up to 1 Year Post-Transplant	Number of participants who did not experience ACR as of the 1-year follow-up.
Composite Rejection Standardized Score (CRSS)	1 Year Post-Transplant	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.
Number of Treated Episodes of ACR	Up to 1 Year Post-Transplant	Number of participants with treated episodes of biopsy-proven or clinically suspected rejection requiring treatment with intravenous methylprednisolone or anti-thymocyte globulin.
Number of Participants With of Chronic Lung Allograft Dysfunction (CLAD)	Up to 1 Year Post-Transplant	Number of participants with at least 1 instance of CLAD.
Number of Participants With De Novo Donor-Specific Antibody (DSA)	Up to 1 Year Post-Transplant	Number of individuals in whom an antibody is detected after transplantation.
Change in Estimated Glomerular Filtration Rate (eGFR)	Baseline, 1 Year Post-Transplant	Change in Estimated Glomerular Filtration Rate (eGFR) at 1 year post-transplant from pre-transplant.
Overall Survival at 1 Year	1 Year Post-Transplant	The percentage of participants who are alive at 1 year post-transplant.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States