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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: Recruiting Phase 2 study of Lung Transplantation and Primary Graft Dysfunction, sponsored by University of California, San Francisco.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT06853223 shows while recruiting
NCT06853223 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 326-participant average among 12 other Lung Transplantation trials with a reported enrollment target (63% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06853223's enrollment target sits among peer trials
120 6th of 12 higher than 7 of 12 other Lung Transplantation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Transplantation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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