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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Envarsus XR | Experimental | Envarsus XR to be initiated once patient is tolerating oral medications |
|
| IR tacrolimus (historical control) | Experimental | Historical cohort of patients maintained on IR tacrolimus following transplant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Composite Rejection Standardized Score (CRSS) |
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Inclusion Criteria:
Prospective arm:
Historical control:
Exclusion Criteria:
Prospective arm:
Historical control:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Angel, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40294109 | Derived | 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. |
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IPD collected for this study will be used for the sole purpose of this study.
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41 individuals were enrolled to participate in the trial; 1 individual did not begin treatment in the study, thus, only 40 participants started the study. Data on 24 historical control individuals were collected and analyzed retrospectively for the secondary outcome measures, but these 24 individuals were not recruited nor enrolled into the study, thus, they are not reflected in the total Protocol Enrollment figure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Envarsus XR | Envarsus XR to be initiated once patient is tolerating oral medications 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. |
| FG001 | IR Tacrolimus (Historical Control) | Historical cohort of patients maintained on IR tacrolimus following transplant. These patients were not enrolled in the trial as participants. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Envarsus XR | Envarsus XR to be initiated once patient is tolerating oral medications 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 1 Year Post-Transplant |
|
2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Envarsus XR | Envarsus XR to be initiated once patient is tolerating oral medications 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allograft failure | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis/pneumonia | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tyler C Lewis | NYU Langone Health | 646-501-4222 | Tyler.lewis@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2021 | Nov 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
|
| 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. |
|
|
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 |
| 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 |
| Overall Survival at 1 Year | The percentage of participants who are alive at 1 year post-transplant. | 1 Year Post-Transplant |
| BG001 | IR Tacrolimus (Historical Control) | Historical cohort of patients maintained on IR tacrolimus following transplant 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Freedom From Acute Cellular Rejection (ACR) at 1 Year | Number of participants who did not experience ACR as of the 1-year follow-up. | Posted | Count of Participants | Participants | Up to 1 Year Post-Transplant |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 Year Post-Transplant |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to 1 Year Post-Transplant |
|
|
|
| Secondary | Number of Participants With of Chronic Lung Allograft Dysfunction (CLAD) | Number of participants with at least 1 instance of CLAD. | Posted | Count of Participants | Participants | Up to 1 Year Post-Transplant |
|
|
|
| Secondary | Number of Participants With De Novo Donor-Specific Antibody (DSA) | Number of individuals in whom an antibody is detected after transplantation. | Posted | Count of Participants | Participants | Up to 1 Year Post-Transplant |
|
|
|
| Secondary | Change in Estimated Glomerular Filtration Rate (eGFR) | Change in Estimated Glomerular Filtration Rate (eGFR) at 1 year post-transplant from pre-transplant. | Posted | Mean | Standard Deviation | mL/min/1.73m2 | Baseline, 1 Year Post-Transplant |
|
|
|
| Secondary | Overall Survival at 1 Year | The percentage of participants who are alive at 1 year post-transplant. | Posted | Number | Percentage of participants | 1 Year Post-Transplant |
|
|
|
| 0 |
| 40 |
| 1 |
| 40 |
| 29 |
| 40 |
| EG001 | Historical Controls | Historical cohort of patients maintained on IR tacrolimus following transplant. These patients were not enrolled in the trial as participants. 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. | 0 | 24 | 0 | 0 | 0 | 0 |
| Acute rejection | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Nausea/vomiting/diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Respiratory viral infection | Infections and infestations | Systematic Assessment |
|
| Hyperglycemia/Hyperosmolar hyperglycemic state (HHS)/Diabetic ketoacidosis (DKA) | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Video-assisted thoracoscopic surgery (VATS) pleurodesis | Surgical and medical procedures | Systematic Assessment |
|
| Cytomegalovirus (CMV) infection | Infections and infestations | Systematic Assessment |
|
| Antibody-mediated rejection | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pleural effusion/thoracentesis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
|
| Anxiety attack | Psychiatric disorders | Systematic Assessment |
|
| Mycobacterium avium-intracellulare (MAI) infection | Infections and infestations | Systematic Assessment |
|
| Peripheral neuropathy/pain | Nervous system disorders | Systematic Assessment |
|
| Hemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Ureterostomy | Renal and urinary disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dysphagia/aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypotension/syncope | Vascular disorders | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | Systematic Assessment |
|
| Drug overdose | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Aspergillus infection | Infections and infestations | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Hemoptysis after transbronchial biopsy | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cough/shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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