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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
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Summary
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.
Official title: Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies.
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-04-14
Completion Date
2028-07-14
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
fostamatinib
The study intervention is fostamatinib, administered orally starting at 100 mg daily for 14 days, escalating to 100 mg BID for 14 days, then 150 mg BID for 28 days, based on tolerability. Patients will be monitored for 28 additional days and randomized to receive either fostamatinib or placebo, along with standard of care.
Placebo
Placebo tablets will match fostamatinib, starting at 100 mg daily for 14 days, escalating to 100 mg BID for 14 days, and then 150 mg BID for 28 days, based on tolerability. Patients will be monitored for an additional 28 days.
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