Envarsus XR in Lung Transplant

Lung Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04420195
• Other study ID #: 19-01247
• Status: Completed
• Phase: Phase 2
• Start date: October 23, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lung Transplant

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 Year Post-Transplant
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.	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.	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.	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.	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.	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.	Baseline, 1 Year Post-Transplant
Secondary	Overall Survival at 1 Year	The percentage of participants who are alive at 1 year post-transplant.	1 Year Post-Transplant