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NCT06948097 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Not yet
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT06948097: Clinical Trial Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT06948097 is a Phase 1 study that has not yet begun recruiting, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06948097, a Phase 1 study, has not yet begun recruiting, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
The primary outcome is the number of participants who discontinue the study drug due to adverse events, intolerance, or other reasons during the treatment period.
Interventions
- DRUG Placebo
- DRUG fostamatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2028-07-14 |
| Phase | Phase 1 |
What is known before NCT06948097 opens enrollment
NCT06948097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06948097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06948097 about?
NCT06948097 is a clinical study titled "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". 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 ...
What is the current status of trial NCT06948097?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-07-15. Estimated completion is 2028-07-14.
What interventions are being tested in trial NCT06948097?
The interventions under investigation include: Placebo (DRUG), fostamatinib (DRUG).
Who is sponsoring clinical trial NCT06948097?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06948097's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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