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Early Use of Long-acting Tacrolimus in Lung Transplant Recipients

RecruitingEARLY Phase 1Ages 18 Years - anyAllVanderbilt University Medical Center
NCT04469842 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Tacrolimus Extended Release Oral Tablet [Envarsus]
  • Tacrolimus
  • Mycophenolate Mofetil Hydrochloride
  • Prednisone
  • Azathioprine
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Where

1 site
Vanderbilt University Medical Center
Nashville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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