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
NotableTrial status: Not Yet Recruiting to Recruiting
Study sites: 5 to 4
Start date: Aug 18, 2026 to Aug 19, 2026
v301
MinorStart date: Aug 17, 2026 to Aug 18, 2026v300
MinorStart date: Aug 16, 2026 to Aug 17, 2026v299
MinorStart date: Aug 13, 2026 to Aug 16, 2026v298
MinorStart date: Aug 12, 2026 to Aug 13, 2026v297
MinorStart date: Aug 11, 2026 to Aug 12, 2026v296
MinorStart date: Aug 10, 2026 to Aug 11, 2026v295
MinorStart date: Aug 7, 2026 to Aug 10, 2026v294
MinorStart date: Aug 6, 2026 to Aug 7, 2026v293
MinorStart date: Aug 5, 2026 to Aug 6, 2026v292
MinorStart date: Aug 4, 2026 to Aug 5, 2026v291
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.