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Completed

NCT Number: NCT04420195

Envarsus XR in Lung Transplant

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.

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Key information

Conditions

Lung Transplant

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: 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.

Other names: Prograf

Primary outcomes

  1. Percentage of Patients Remaining on Envarsus XR at 1 Year

    Time frame: 1 Year Post-Transplant

    The primary endpoint is the percentage of patients remaining on Envarsus XR at the 1-year follow-up visit.

Secondary outcomes

  1. Freedom From Acute Cellular Rejection (ACR) at 1 Year

    Time frame: Up to 1 Year Post-Transplant

    Number of participants who did not experience ACR as of the 1-year follow-up.

  2. Composite Rejection Standardized Score (CRSS)

    Time frame: 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.

  3. Number of Treated Episodes of ACR

    Time frame: 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.

  4. Number of Participants With of Chronic Lung Allograft Dysfunction (CLAD)

    Time frame: Up to 1 Year Post-Transplant

    Number of participants with at least 1 instance of CLAD.

  5. Number of Participants With De Novo Donor-Specific Antibody (DSA)

    Time frame: Up to 1 Year Post-Transplant

    Number of individuals in whom an antibody is detected after transplantation.

  6. Change in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Baseline, 1 Year Post-Transplant

    Change in Estimated Glomerular Filtration Rate (eGFR) at 1 year post-transplant from pre-transplant.

  7. Overall Survival at 1 Year

    Time frame: 1 Year Post-Transplant

    The percentage of participants who are alive at 1 year post-transplant.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2020
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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