30 Participants Needed

Fostamatinib for Lung Transplant Rejection

Recruiting at 4 trial locations
ST
Overseen BySean T Agbor-Enoh, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

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

ST

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

Have provided signed written informed consent, prior to performing any study procedure, including screening procedures
First time LT recipients
No prior demonstration of DSA
See 5 more

Exclusion Criteria

Have a significant medical condition that confers an unacceptable risk to participating in the study, and/or that could confound the interpretation of the study data
History of neutropenia, posterior reversible encephalopathy syndrome (PRES), poorly controlled hypertension, positive post-transplant active hepatitis C and/or hepatitis B viral infection, drug-induced cholestatic hepatitis, any primary malignancy, testing positive for human immunodeficiency virus 1 or 2 Ab with evidence for ongoing active infection, current or recent history of psychiatric disorder that could compromise cooperation with study visits and procedures, currently enrolled in another therapeutic clinical trial involving ongoing therapy with any investigational or marketed product or placebo, prior lung or any organ transplant, currently pregnant or lactating, estimated glomerular filtration rate less than 30 mL/min, current or history of grade 3 diarrhea
I am taking medication that strongly affects liver enzyme levels.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

8 weeks
Clinic visits every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 follow-up visit

Treatment Details

Interventions

  • Fostamatinib
Trial Overview The study tests fostamatinib, an oral medication, against a placebo to see if it helps prevent organ rejection in patients with DSA. The treatment lasts for 8 weeks with clinic visits every 2 weeks for monitoring.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: FostamatinibExperimental Treatment1 Intervention
Patients will receive fostamatinib with standard of care to assess safety in LT recipients with positive DSA.
Group II: PlaceboPlacebo Group1 Intervention
Patients will receive placebo with standard of care to assess safety in LT recipients with positive DSA.

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials
3,987
Recruited
47,860,000+

Findings from Research

Fostamatinib is an oral spleen tyrosine kinase inhibitor that effectively increases platelet counts in adults with immune thrombocytopenia who did not respond adequately to previous treatments, as shown in two Phase III trials.
The treatment is generally well tolerated, with lower rates of severe bleeding-related side effects, although common adverse events include diarrhea, nausea, and liver function test elevations.
Fostamatinib for the treatment of immune thrombocytopenia in adults.Moore, DC., Gebru, T., Muslimani, A.[2021]
Fostamatinib is an effective treatment for chronic immune thrombocytopenia (ITP) in patients who have not responded adequately to at least one prior therapy, as demonstrated in two phase 3 randomized controlled trials (FIT1 and FIT2) across North America, Australia, and Europe.
The drug works by inhibiting spleen tyrosine kinase, which plays a crucial role in the immune response, thereby helping to increase platelet counts in ITP patients.
Fostamatinib for the treatment of chronic immune thrombocytopenia.Connell, NT., Berliner, N.[2021]

References

Fostamatinib for the treatment of immune thrombocytopenia in adults. [2021]
Fostamatinib for the treatment of chronic immune thrombocytopenia. [2021]
A phase II trial to evaluate the efficacy of fostamatinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). [2022]
A phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 2 dosing regimens of fostamatinib in patients with rheumatoid arthritis with an inadequate response to a tumor necrosis factor-α antagonist. [2022]
An oral Syk kinase inhibitor in the treatment of rheumatoid arthritis: a three-month randomized, placebo-controlled, phase II study in patients with active rheumatoid arthritis that did not respond to biologic agents. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security