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

RecruitingPhase 2Ages 18 Years - anyAllUniversity of California, San Francisco
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male or female โ‰ฅ18 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.
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What it tests

  • Maraviroc
  • Placebo
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Where

1 site
University of California, San Francisco
San Francisco, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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