Lung Transplant Clinical Trials

Clinical trials related to Lung Transplant Procedure

A Randomized Trial of CCR5 Inhibition as a Complement to Lung Transplant Induction Immunosuppression

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Male or female ≥18 years of age at the time of lung transplant waitlisting.

• Listed for a bilateral lung transplantation.

• Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

• PGD risk score \> 50% at the time of donor organ offer

• Planned induction with basiliximab, mycophenolatge, and prednisone and routine maintenance immunosuppression of tacrolimus, mycophenolate and prednisone.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Daniel R Calabrese, MD
Daniel.Calabrese@ucsf.edu
415-467-8700
Time Frame
Start Date: 2025-12-07
Estimated Completion Date: 2028-08-14
Participants
Target number of participants: 120
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov