Phase 2
N=64
Envarsus XR in Lung Transplant
Lung Transplant
Bottom Line
View on ClinicalTrials.gov: NCT04420195 ↗Enrolled (actual)
64
Serious AEs
2.5%
Results posted
Jan 2024
Primary outcome: Primary: Percentage of Patients Remaining on Envarsus XR at 1 Year — 40 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Extended-Release Tacrolimus (Drug); Immediate-Release Tacrolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Remaining on Envarsus XR at 1 Year |
40 | — |
| SECONDARY Freedom From Acute Cellular Rejection (ACR) at 1 Year |
5; 6 | — |
| SECONDARY Composite Rejection Standardized Score (CRSS) |
0.19; 0.33 | — |
| SECONDARY Number of Treated Episodes of ACR |
8; 6 | — |
| SECONDARY Number of Participants With of Chronic Lung Allograft Dysfunction (CLAD) |
0; 0 | — |
| SECONDARY Number of Participants With De Novo Donor-Specific Antibody (DSA) |
19; 4 | — |
| SECONDARY Change in Estimated Glomerular Filtration Rate (eGFR) |
-56.2; -40.3 | — |
| SECONDARY Overall Survival at 1 Year |
100; 100 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04420195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.