Lung TransplantPhase 2NCT04420195
Envarsus XR in Lung Transplant
A Phase 2 study testing Extended-Release Tacrolimus and Immediate-Release Tacrolimus in people with Lung Transplant, run by NYU Langone Health at 1 site in United States.
Trial summary
Patients undergoing a lung transplant will be enrolled. All patients will undergo lung transplantation with standard post-operative management, including triple immunosuppression. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Transplant
- What is being tested?
- Extended-Release Tacrolimus and Immediate-Release Tacrolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2020to 30 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- Age ≥ 18 years
- Received a lung transplant at NYU Langone Health
- Completed one year from transplant on IR tacrolimus
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Transplant
- Being tested
- Extended-Release Tacrolimus, Immediate-Release Tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-Release TacrolimusDrug
Also called Envarsus XR
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.
Immediate-Release TacrolimusDrug
Also called Prograf
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.
| Study group | Role | What they receive |
|---|---|---|
| Envarsus XR | Experimental | Envarsus XR to be initiated once patient is tolerating oral medications Receives: Drug: Extended-Release Tacrolimus |
| IR tacrolimus (historical control) | Experimental | Historical cohort of patients maintained on IR tacrolimus following transplant Receives: Drug: Immediate-Release Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Year Post-Transplant
Secondary outcomes (7)
Freedom From Acute Cellular Rejection (ACR) at 1 Year
Number of participants who did not experience ACR as of the 1-year follow-up.
Measured: Up to 1 Year Post-Transplant
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 Year Post-Transplant
Overall Survival at 1 Year
The percentage of participants who are alive at 1 year post-transplant.
Measured: 1 Year Post-Transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start23 Oct 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis Angel, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420195
- Sponsor's protocol ID
- 19-01247
- Status last verified
- Jan 2024
- First submitted
- 4 Jun 2020
- Last updated
- 22 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD collected for this study will be used for the sole purpose of this study.
Publications
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.
PubMed 40294109
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Comparing Early Conversion to Extended-Release Tacrolimus (ENVARSUS XR) to Immediate-Release Tacrolimus in Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT04420195
- Acronym / sponsor ID
- 19-01247
- Conditions
- Lung Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Posted 22 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Envarsus XR | Experimental | Drug: Extended-Release TacrolimusEnvarsus XR to be initiated once patient is tolerating oral medications |
| IR tacrolimus (historical control) | Experimental | Drug: Immediate-Release TacrolimusHistorical cohort of patients maintained on IR tacrolimus following transplant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Age ≥ 18 years
Key exclusion criteria (6 listed)
- Contraindication to tacrolimus due to allergic or adverse reactions
- Pregnant or nursing women
- Multi-organ transplant recipient
- Contraindication to tacrolimus due to allergic or adverse reactions (not including chronic kidney disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended-Release TacrolimusAlso: Envarsus XREnvarsus 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. | Drug | Envarsus XR |
| Immediate-Release TacrolimusAlso: PrografHistorical 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. | Drug | IR tacrolimus (historical control) |
Primary outcome
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.
7 secondary outcomes
Freedom From Acute Cellular Rejection (ACR) at 1 Year
Time frame: Up to 1 Year Post-Transplant
Composite Rejection Standardized Score (CRSS)
Time frame: 1 Year Post-Transplant
Number of Treated Episodes of ACR
Time frame: Up to 1 Year Post-Transplant
Number of Participants With of Chronic Lung Allograft Dysfunction (CLAD)
Time frame: Up to 1 Year Post-Transplant
Number of Participants With De Novo Donor-Specific Antibody (DSA)
Time frame: Up to 1 Year Post-Transplant
Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline, 1 Year Post-Transplant
Overall Survival at 1 Year
Time frame: 1 Year Post-Transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40294109Lewis 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.
- Individual participant dataSharing planned: No. IPD collected for this study will be used for the sole purpose of this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Angel, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Extended-Release Tacrolimus and Immediate-Release Tacrolimus in people with Lung Transplant, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Remaining on Envarsus XR at 1 Year (time frame: 1 Year Post-Transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04420195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.