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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06853223
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Lung Injury(ALI)
  • Lung Transplantation
  • Natural Killer Cell Mediated Immunity
  • Primary Graft Dysfunction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Maraviroc — DRUG
    Product will be administered for 300 mg immediately preceding the lung transplant surgery and then will be administered every 12 hours. There will be 7 total doses. The first 3 will be 300 mg doses and the remaining 4 will be 150 mg doses. Maraviroc will be given oral (PO) or by feeding tube (PFT) in crushed format depending on the route availability.
  • Placebo — DRUG
    Placebo in 300 and 150 mg formulations Product will be administered every 12 hours for 3 days. The placebo will be matched in appearance and taste to the Maraviroc and is available in PO and liquid (PFT) formulations.

Study Details

Lung transplant recipient survival lags other solid organ recipients, with the main early cause of death being primary graft dysfunction (PGD). PGD occurs in up to 1/3 of all recipients, is driven by the body's innate immune response, and has no known medical therapies for treatment or prevention. Investigators have recently shown that Natural Killer (NK) cells, a key innate immune cell, are critical in causing PGD. Importantly, the investigators found that Maraviroc, an FDA-approved drug that works to inhibit these immune cells, prevented lung injury in mouse models of PGD. The goal of this clinical trial is to learn if Maraviroc works to treat PGD in Lung Transplant patients who are above the age of 18 and have a PGD risk score greater than 50%. The objectives the study hopes to address are: To address the safety and tolerability of Maraviroc. To test a strategy for PGD enrichment in a lung transplant population. To measure the efficacy and biological efficacy of using Maraviroc. To study the biochemical, physiologic, and molecular effects of the drug on the body. This will be a double blind study where patients will either get the Maraviroc drug or a placebo. Researchers will then compare the two groups to address the above objectives. Participants will: Take drug Maraviroc or a placebo every 12 hours for 3 days post surgery. Follow up will occur during the entire length of stay at UCSF, about 16 days, with a single 12 month follow up once released.

Key Dates

Start date
Dec 7, 2025
Status verified
Jan 2026
Primary completion
Apr 1, 2028
Completion
Aug 14, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Maraviroc
    This arm is the Maraviroc drug which will be administered to patients.
  • Placebo Comparator: Placebo
    This arm is the placebo drug which will be matched in appearance and taste to the Maraviroc and is available in PO and liquid (PFT) formulations.

Primary Outcome Measure

Incidence of severe Primary Graft Dysfunction [ Time Frame: 3 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Daniel Calabrese
[email protected]
415-514-8600

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By research site
University of California, San Francisco· San Francisco, CA

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