Fostamatinib for Lung Transplant Rejection
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants will continue with their standard care after a transplant, so it seems likely you can keep taking your usual medications.
What data supports the effectiveness of the drug Fostamatinib for lung transplant rejection?
Fostamatinib has shown effectiveness in treating immune-related conditions like chronic immune thrombocytopenia (a condition where the immune system attacks platelets) and rheumatoid arthritis (a condition causing joint inflammation), suggesting it may help with immune responses involved in lung transplant rejection.12345
What is the purpose of this trial?
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.
Research Team
Sean T Agbor-Enoh, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria
This trial is for adults over 18 who have had a lung transplant and then developed donor-specific antibodies, which can lead to organ rejection. Participants will continue their standard post-transplant care.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive fostamatinib or placebo, starting with 100 mg orally daily for 2 weeks, then escalating to 100 mg twice daily for 2 weeks, and finally 150 mg twice daily for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Fostamatinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor