Early Use of Long-acting Tacrolimus in Lung Transplant Recipients

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Jul 9, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a new form of a medication called Long-acting Tacrolimus (LCP-tacrolimus) for patients who have received a lung transplant. After a lung transplant, patients need to take medications to help prevent their body from rejecting the new lungs. This study aims to see if starting LCP-tacrolimus early after the transplant can help with this while also protecting the kidneys from potential damage caused by traditional forms of tacrolimus. The researchers want to find out if LCP-tacrolimus is safe and well-tolerated in lung transplant recipients.

To participate in this study, individuals must be at least 18 years old, have recently undergone a single or double lung transplant, and be able to understand and give consent for the study. Those with certain conditions, like active infections, severe kidney issues, or a history of not responding well to tacrolimus, may not be eligible. Participants in the trial can expect to receive careful monitoring to ensure their safety and to evaluate how well the new medication works. This is an important step in finding better treatment options for lung transplant patients.

Gender

ALL

Eligibility criteria

• 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