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Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies
Condition: Lung Transplantation · Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
About this study
Background: People who have lung transplants often survive 6 or 7 years. But some people develop donor-specific antibodies (DSA) after their transplants; antibodies are proteins that attack foreign invaders in the body. Antibodies typically kill viruses and other agents that can cause disease. But when the antibodies attack a transplanted organ, they can cause the body to reject the new tissues. People who develop DSA after a transplant have a higher risk of death within 1 year. Objective: To test a drug called fostamatinib in people who develop DSA after a lung transplant. Eligibility: Adults aged 18 and older who developed DSA after a lung transplant. Design: Participants will continue with their standard care after a transplant. Fostamatinib is a pill taken by mouth. Some participants will take the study drug along with their standard care; others will take a placebo. A placebo is a pill that looks just like the real drug but contains no medicine. All participants will take 1 pill per day for 2 weeks. Then they will take 2 pills per day for the next 6 weeks. Participants will have clinic visits every 2 weeks while taking their pills. They will have a physical exam, with blood and urine tests, during each visit. If participants have fluid samples collected from their airways during their standard treatment, some extra fluid may be collected for this study. Participants will have a follow-up visit 4 weeks after they stop taking their pills.
This description comes directly from the study's public registry record.
Talk to the study team
Sean T Agbor-Enoh, M.D. · (703) 677-4630 · agborenohst@mail.nih.gov
Always discuss trial participation with your own doctor first.
Locations (5)
| Stanford University School of Medicine | Stanford, California, United States | — |
| Johns Hopkins University School of Medicine | Baltimore, Maryland, United States | — |
| National Heart, Lung and Blood Institute (NHLBI) | Bethesda, Maryland, United States | — |
| University of Utah Health | Salt Lake City, Utah, United States | — |
| Inova Health System Foundation | Falls Church, Virginia, United States | — |
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Source record: clinicaltrials.gov/study/NCT06948097