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Study identifier: NCT04469842 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Early Use of Long-acting Tacrolimus in Lung Transplant Recipients

Condition: Lung Transplant; Complications  ·  Sponsor: Vanderbilt University Medical Center

PhaseEARLY_Phase 1
Planned participants48
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Lung transplantation is a life-saving therapy for patients with advanced lung disease, however, necessitates the use of life-long immunosuppressive therapy for the prevention of acute and chronic rejection. The backbone of immunosuppression is the calcineurin-inhibitor class, with tacrolimus being the preferred drug due to its potency and improved side-effect profile. Nevertheless, tacrolimus is associated with several side effects including increased risk for infection and malignancy, tremors, headaches, seizures, hypertension, leukopenia and renal dysfunction. In fact, by 6 months post-transplant, 50% of patients will have a 50% decline in eGFR and by 5 years post-transplant \~10% of patients will have advanced renal disease that may require renal replacement therapy and/or kidney transplantation. Tacrolimus induces a nephropathy in two ways- acute calcineurin inhibitor nephrotoxicity (CIN) is mediated by afferent arteriolar vasoconstriction, whereas chronic CIN is due to interstitial nephritis and fibrosis. Immunosuppressive regimens that spare or dose-reduce calcineurin inhibitors have been shown to have a modest impact on preserving renal function, but are limited by timing. Although most studies support implementing renal preserving protocols early on, this is balanced by the potential for acute cellular rejection, antibody mediated rejection and anastomotic dehiscence. Long-acting Tacrolimus (LCP-tacrolimus) may have the potential to bridge the balance of providing po…

This description comes directly from the study's public registry record.

Talk to the study team

Anil J Trindade, MD  ·  615-875-1380  ·  anil.trindade@vumc.org

Haley Hoy, PhD, NP  ·  615-202-8576  ·  haley.hoy@vumc.org

Always discuss trial participation with your own doctor first.

Locations (1)

Vanderbilt University Medical CenterNashville, Tennessee, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04469842