This Study is Assessing the Safety and Efficacy of Immune Inhibition as a Treatment to Prevent Primary Graft Dysfunction

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Feb 24, 2025

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ClinConnect Summary

This clinical trial is investigating a medication called Maraviroc to see if it can help prevent a serious condition known as primary graft dysfunction (PGD) in lung transplant patients. PGD is a major cause of early death after lung transplantation and affects about one-third of recipients. The study will involve adults over 18 years old who are at higher risk for PGD, specifically those with a risk score greater than 50%. Researchers want to determine whether Maraviroc is safe, how well it works, and its effects on the body.

Participants in this trial will take either Maraviroc or a placebo (a harmless pill with no active medication) every 12 hours for three days after their lung transplant surgery. The study will last about 16 days in the hospital, followed by a follow-up appointment 12 months later. To be eligible, participants must be waiting for a bilateral lung transplant and meet certain health criteria. This trial is not yet recruiting, but it aims to provide valuable insights into improving outcomes for lung transplant patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female ≥18 years of age at the time of lung transplant waitlisting.
• • 2. Listed for a bilateral lung transplantation.
• • 3. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
• • 4. PGD risk score \> 50% at the time of donor organ offer
• • 5. Planned induction with basiliximab, mycophenolatge, and prednisone and routine maintenance immunosuppression of tacrolimus, mycophenolate and prednisone.
• Exclusion Criteria:
• • 1. Recipient scheduled to receive alternate induction regimen that is cell depleting such as anti-thymocyte globulin or alemtuzumab.
• • 2. Active chronic pulmonary infection in the recipient that are considered relative contraindications to lung transplantation such as Burkholderia or Mycobacterium abscessus.
• • 3. Recipients receiving HIV, HCV or HBV positive donor organs. Only documented infections are considered exclusion criteria. Recipients receiving increased risk organs will not be excluded.
• • 4. Recipient listed for concurrent heart or other solid organ transplantation.
• • 5. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.