Status:
RECRUITING
Early Use of Long-acting Tacrolimus in Lung Transplant Recipients
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
Lung Transplant; Complications
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 reje...
Detailed Description
Lung transplantation is a life-saving therapy for patients with end-stage lung disease refractory to medical treatment, providing an improvement in both survival and quality of life.\[1,2\] Despite th...
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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04469842
Start Date
December 1 2023
End Date
December 31 2026
Last Update
March 10 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232