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NCT06853223 · ClinicalTrials.gov registry record · Phase 2
This Study is Assessing the Safety and Efficacy of Immune Inhibition as a Treatment to Prevent Primary Graft Dysfunction
A Phase 2 study of Lung Transplantation and Primary Graft Dysfunction, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT06853223 is a Phase 2 study of Lung Transplantation and Primary Graft Dysfunction that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 120 participants, below the 326-participant average among 12 other Lung Transplantation trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06853223, a Phase 2 study of Lung Transplantation and Primary Graft Dysfunction, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
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 Studied
Interventions
- DRUG Placebo
- DRUG Maraviroc
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-12-07 |
| Est. Completion | 2028-08-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06853223
The ClinicalTrials.gov registry entry for NCT06853223 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 326-participant average among 12 other Lung Transplantation trials with a reported enrollment target (63% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Lung Transplantation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06853223 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06853223 about?
NCT06853223 is a clinical study titled "This Study is Assessing the Safety and Efficacy of Immune Inhibition as a Treatment to Prevent Primary Graft Dysfunction". 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. I...
What is the current status of trial NCT06853223?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2025-12-07. Estimated completion is 2028-08-14.
What conditions does trial NCT06853223 study?
This clinical trial studies the following conditions: Lung Transplantation, Primary Graft Dysfunction, Acute Lung Injury(ALI), Natural Killer Cell Mediated Immunity.
What interventions are being tested in trial NCT06853223?
The interventions under investigation include: Placebo (DRUG), Maraviroc (DRUG).
Who is sponsoring clinical trial NCT06853223?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06853223 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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