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Early Use of Long-acting Tacrolimus in Lung Transplant Recipients

This study is looking at whether a long-acting form of tacrolimus (Envarsus) is safe and well-tolerated when given early to people who have had a lung transplant. Tacrolimus is a medicine used to prevent your body from rejecting the new lung. The study will compare this long-acting tacrolimus to the standard, intermediate-release tacrolimus, both given with other common immunosuppressant medicines like mycophenolate mofetil hydrochloride, prednisone, or azathioprine. To join, you must be at least 18 years old, have recently had a single or bilateral lung transplant, and receive care at VUMC. The main goal is to see how safe and tolerable the treatments are over 6 months. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 48 participants. It compares two different tacrolimus regimens.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to assess safety and tolerability for 6 months.

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NCT04469842

Early Use of Long-acting Tacrolimus in Lung Transplant Recipients

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Vanderbilt University Medical Center
~48 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Tacrolimus Extended Release Oral Tablet [Envarsus]TacrolimusMycophenolate Mofetil HydrochloridePrednisoneAzathioprine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability
Measured over 6 months

Conditions

Lung Transplant; Complications

Explore related trials

Lung Transplantation

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Anil J Trindade, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Anil J Trindade, MD
[email protected]
615-875-1380
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Safety and Tolerability6 months

    Composite of mortality, allograft failure, potential drug induced liver injury, supra-therapeutic trough levels (\>20 ng/mL), sub-therapeutic trough levels (\<5 ng/mL), seizures, encephalopathy, thrombotic microangiopathy and serious hyperkalemia associated with use of LCP-tacrolimus, compared to matched historical controls administered IR-tacrolimus.