Envarsus XR in Lung Transplant

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Transplant
• Intervention / Treatment: Drug: Extended-Release Tacrolimus; Drug: Immediate-Release Tacrolimus

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
Overall Survival at 1 Year	The percentage of participants who are alive at 1 year post-transplant.	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.	Up to 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.	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.	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.	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.	Baseline, 1 Year Post-Transplant

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Luis Angel, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2020
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: 19-01247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD collected for this study will be used for the sole purpose of this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No