Using long-acting tacrolimus for lung transplant patients
Official title: A Prospective, Randomized, Controlled Pilot Study of Early-Use Long Acting Tacrolimus (Envarsus XR) in Lung Transplant Recipients
Run by Vanderbilt University Medical Center · NCT04469842 · Data updated 2026-11-12
This study is testing if a new long-acting version of tacrolimus can help lung transplant patients avoid complications and protect their kidneys better than traditional medications.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Status | Recruiting |
| Started | December 1, 2023 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT04469842 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who have recently undergone single or bilateral lung transplantation.
✕Probably not a fit
Patients with a history of prior organ transplantation or those who have had adverse reactions to tacrolimus may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the early use of long-acting tacrolimus in patients who have undergone lung transplantation. The study aims to assess the effectiveness of this medication in reducing complications associated with traditional immunosuppressive therapies, particularly focusing on preventing renal dysfunction. Participants will receive a regimen that includes tacrolimus extended release, along with other immunosuppressive agents, to evaluate its safety and efficacy. The trial is designed for patients who are adherent to their medical therapies and are receiving care at Vanderbilt University Medical Center.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of renal complications in lung transplant recipients.
How similar studies have gone: Other studies have shown promising results with similar immunosuppressive strategies, but this specific approach with long-acting tacrolimus is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Status-post single or bilateral lung transplantation * Participant is able to give informed consent for participation in the study. * Male or female age 18 years or above. * Actively receives care at VUMC and is adherent with medical therapies. Exclusion Criteria: * History of prior organ transplantation * History of tacrolimus use prior to transplantation * Intolerance of tacrolimus (that precludes use) * Having DSA pre-transplant (Positive virtual crossmatch) * Active infection with Hepatitis B or C * Active infection with Human Immunodeficiency Virus (HIV) * Baseline AST / ALT \> three times upper limit normal * Primary graft dysfunction grade 3 at 72 hours * Acute kidney injury during index hospitalization that does not resolve to two times the pre-transplant baseline value. * Contraindication to PO (per os) intake of medications * Impaired GI absorption (defined as sublingual administration of IR-tacro) * History of frequent headaches * Seizure history * Cannot provide consent (at least verbally) * Pregnancy or breast-feeding * Participation in another interventional clinical trial
Where it's running
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Vanderbilt University Medical Center
Nashville, Tennessee, United States Recruiting
Study contacts
- Principal investigator: Anil J Trindade, MD — Vanderbilt University Medical Center
- Study coordinator: Anil J Trindade, MD
- Email: anil.trindade@vumc.org
- Phone: 615-875-1380
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.