Envarsus XR in Lung Transplant

NCT04420195 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 19-01247
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

Envarsus XR

EXPERIMENTAL

Envarsus XR to be initiated once patient is tolerating oral medications

Drug: Extended-Release Tacrolimus

IR tacrolimus (historical control)

EXPERIMENTAL

Historical cohort of patients maintained on IR tacrolimus following transplant

Drug: Immediate-Release Tacrolimus

Interventions

Extended-Release Tacrolimus DRUG

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.

Also known as: Envarsus XR

Envarsus XR

Immediate-Release Tacrolimus DRUG

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.

Also known as: Prograf

IR tacrolimus (historical control)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• Lewis TC, Hotchkis P, Wong A, Lamaina V, Fitzpatrick E, Stiefel A, Ohanian J, Schnier JR, Lesko M, Rudym D, Natalini JG, Angel LF. Comparison of Early Conversion to LCP-Tacrolimus (ENVARSUS XR) to Immediate-Release Tacrolimus in Lung Transplant Recipients. Clin Transplant. 2025 May;39(5):e70159. doi: 10.1111/ctr.70159.

  PMID: 40294109 DERIVED

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Tyler C Lewis
• Organization: NYU Langone Health

Tyler.lewis@nyulangone.org

646-501-4222

Study Officials

• Luis Angel, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: October 23, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: January 22, 2024
• Results First Posted: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)