Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
ID04469842

Early Use of Long-acting Tacrolimus Compared to Standard Tacrolimus in Lung Transplant Recipients A Prospective, Randomized, Controlled Pilot Study

Led by Vanderbilt University Medical Center · Updated on 2026-05-15

48

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

V

Vanderbilt University Medical Center

Lead Sponsor

V

Veloxis Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the early use of long-acting tacrolimus (LCP-tacrolimus) compared to intermediate-release tacrolimus (IR-tacrolimus) in lung transplant recipients. Lung transplantation requires lifelong immunosuppressive treatment to prevent rejection, but current drugs like tacrolimus can cause serious side effects including kidney damage, infections, and neurological issues. The study focuses on whether using LCP-tacrolimus soon after transplant can be safe and better tolerated while preserving kidney function. Participants will be randomly assigned to receive daily LCP-tacrolimus or twice-daily IR-tacrolimus for seven months, both targeting specific blood trough levels. Additional immunosuppressants such as mycophenolate mofetil or azathioprine, along with prednisone, will be given in both groups. The study will evaluate treatment safety, tolerability, and side effects during this period. During the trial, participants will have regular assessments including kidney function tests, monitoring for rejection episodes, evaluation of headaches and tremors, and quality of life related to side effects. Researchers will observe for antibody development and monitor safety for up to nine months post-transplant. The study participation involves close medical follow-up to measure these outcomes and ensure patient well-being.

CONDITIONS

Brief Title

Early Use of Long-acting Tacrolimus in Lung Transplant Recipients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Status-post single or bilateral lung transplantation
  • Able to give informed consent for study participation
  • Male or female aged 18 years or older
  • Actively receiving care at Vanderbilt University Medical Center and adherent with medical therapies
Not Eligible

You will not qualify if you...

  • History of prior organ transplantation
  • History of tacrolimus use before transplantation
  • Intolerance to tacrolimus that prevents use
  • Pre-transplant positive virtual crossmatch indicating donor-specific antibodies
  • Active infection with Hepatitis B or C
  • Active infection with Human Immunodeficiency Virus (HIV)
  • Baseline AST or ALT levels more than three times the upper limit of normal
  • Primary graft dysfunction grade 3 at 72 hours post-transplant
  • Acute kidney injury during initial hospitalization that does not improve to twice the pre-transplant baseline
  • Inability to take oral medications
  • Impaired gastrointestinal absorption defined by sublingual administration of IR-tacrolimus
  • History of frequent headaches
  • History of seizures
  • Unable to provide at least verbal consent
  • Pregnancy or breastfeeding
  • Participation in another interventional clinical trial

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 7 months

Participants receive immunosuppression with either long-acting tacrolimus or intermediate-release tacrolimus, along with standard additional immunosuppressive medications, to manage their lung transplant.

Daily dosing with tacrolimus; visit frequency as per standard clinical care

Follow-up

Duration - 2 months

Participants are monitored for safety, tolerability, renal function, rejection episodes, and side effects related to immunosuppression after the treatment period.

Visits as scheduled for assessments up to 9 months post-transplant

Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

A

Anil J Trindade, MD

H

Haley Hoy, PhD, NP

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Effect of Lung Transplantation on Health-Related Quality of Life in the Era of the Lung Allocation Score: A U.S. Prospective Cohort Study.

J P Singer, P P Katz, A Soong...

https://pubmed.ncbi.nlm.nih.gov/27743488

The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-sixth adult lung and heart-lung transplantation Report-2019; Focus theme: Donor and recipient size match.

Daniel C Chambers, Wida S Cherikh, Michael O Harhay...

https://pubmed.ncbi.nlm.nih.gov/31548030