CCR5 immune blockade to prevent primary graft dysfunction after lung transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 2 interventional trial gives adults at high risk for PGD either Maraviroc or placebo around the time of bilateral lung transplantation to test safety, tolerability, and biological effect. Investigators will measure clinical outcomes including PGD incidence, monitor adverse events and drug-drug interactions, and measure Maraviroc levels in plasma and bronchoalveolar lavage. They will assess bronchoalveolar lavage NK cells and other donor and recipient biomarkers as surrogate markers of biological efficacy and to develop subphenotyping assays for future multicenter trials. A secondary aim is to pilot an enrichment strategy to identify and recruit patients with a greater than 50% predicted PGD risk ahead of transplant.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Daniel Calabrese, MD — University of California, San Francisco
• Study coordinator: Daniel R Calabrese, MD
• Email: Daniel.Calabrese@ucsf.edu
• Phone: 415-467-8700

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.