Actively Recruiting
This Study is Assessing the Safety and Efficacy of Immune Inhibition as a Treatment to Prevent Primary Graft Dysfunction
Led by University of California, San Francisco · Updated on 2026-01-20
120
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
This Study is Assessing the Safety and Efficacy of Immune Inhibition as a Treatment to Prevent Primary Graft Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older at the time of lung transplant waitlisting
- Listed for a bilateral lung transplantation
- Written informed consent obtained and ability to comply with study requirements
- Primary Graft Dysfunction (PGD) risk score greater than 50% at time of donor organ offer
- Planned induction with basiliximab, mycophenolate, and prednisone and maintenance immunosuppression with tacrolimus, mycophenolate, and prednisone
You will not qualify if you...
- Scheduled to receive alternate cell-depleting induction regimen such as anti-thymocyte globulin or alemtuzumab
- Active chronic pulmonary infections considered relative contraindications to lung transplantation, such as Burkholderia or Mycobacterium abscessus
- Receiving donor organs positive for HIV, HCV, or HBV infections (documented infections only)
- Listed for concurrent heart or other solid organ transplantation
- Any condition or abnormality that the Investigator believes compromises patient safety or study data quality
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
D
Daniel R Calabrese, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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