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Calcineurin Inhibitor

Extended-Release Tacrolimus for Lung Transplant

Phase 2
Waitlist Available
Led By Luis Angel, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-transplant
Awards & highlights

Study Summary

This trial is testing if a certain immunosuppressant drug is more effective than another when given to patients who have had a lung transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Patients Remaining on Envarsus XR at 1 Year
Secondary outcome measures
Change in Estimated Glomerular Filtration Rate (eGFR)
Composite Rejection Standardized Score (CRSS)
Freedom From Acute Cellular Rejection (ACR) at 1 Year
+4 more

Side effects data

From 2022 Phase 2 trial • 41 Patients • NCT04420195
23%
Acute rejection
20%
Sepsis/pneumonia
18%
Nausea/vomiting/diarrhea
13%
Respiratory viral infection
8%
Hyperglycemia/Hyperosmolar hyperglycemic state (HHS)/Diabetic ketoacidosis (DKA)
5%
Video-assisted thoracoscopic surgery (VATS) pleurodesis
5%
Cytomegalovirus (CMV) infection
5%
Antibody-mediated rejection
5%
Hyponatremia
5%
Pleural effusion/thoracentesis
5%
Diverticulitis
3%
Cough/shortness of breath
3%
Acute kidney injury
3%
Sinusitis
3%
Anxiety attack
3%
Hypotension/syncope
3%
Hemothorax
3%
Pericarditis
3%
Peripheral neuropathy/pain
3%
Aspergillus infection
3%
Drug overdose
3%
Allograft failure
3%
Dysphagia/aspiration
3%
Pneumothorax
3%
Mycobacterium avium-intracellulare (MAI) infection
3%
Hemoptysis after transbronchial biopsy
3%
Ureterostomy
3%
Arrhythmia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Envarsus XR
Historical Controls

Trial Design

2Treatment groups
Experimental Treatment
Group I: IR tacrolimus (historical control)Experimental Treatment1 Intervention
Historical cohort of patients maintained on IR tacrolimus following transplant
Group II: Envarsus XRExperimental Treatment1 Intervention
Envarsus XR to be initiated once patient is tolerating oral medications
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Immediate-Release Tacrolimus
2020
Completed Phase 2
~50
Extended-Release Tacrolimus
2020
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,594 Total Patients Enrolled
Luis Angel, MDPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
76 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Envarsus XR in Lung Transplant
2020. "Envarsus XR in Lung Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04420195.
~9 spots leftby Apr 2025
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