Envarsus XR in Lung Transplant

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-23

Study Completion Date

2022-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Early Use of Long-acting Tacrolimus in Lung Transplant Recipients

NCT04469842

Lung Transplant; Complications

RECRUITING EARLY_PHASE1

Envarsus XR Compared to Immediate Release Tacrolimus

NCT03979365

Kidney Transplant Recipients

COMPLETED PHASE4

Prospective Pilot Feasibility Study Comparing Envarsus Once-a-day to Tacrolimus Twice-a-day Immunosuppressive Regimen on Drug Bioavailability in Hispanic First Time Kidney Transplant Recipients

NCT03438773

Kidney Transplant; Complications Kidney Transplant Failure and Rejection

UNKNOWN PHASE1

Efficacy of Envarsus XR and Digital Health Technology in Reducing Tacrolimus Fluctuation and Frequency of Dose Changes

NCT04711291

Medication Adherence Renal Transplant

WITHDRAWN NA

Comparison of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients

NCT04225988

Kidney Transplant Rejection

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Transplant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Envarsus XR

Envarsus XR to be initiated once patient is tolerating oral medications

Group Type EXPERIMENTAL

Extended-Release Tacrolimus

Intervention Type 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.

IR tacrolimus (historical control)

Historical cohort of patients maintained on IR tacrolimus following transplant

Group Type EXPERIMENTAL

Immediate-Release Tacrolimus

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Envarsus XR Prograf

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No