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NCT03644667 · ClinicalTrials.gov registry record · Phase 2
Tocilizumab in Cardiac Transplantation
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 385
- Enrollment target
NCT03644667: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03644667 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 385 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (189% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03644667, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 385 participants
- Enrollment target
Study Summary
The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Specifically, the investigators will evaluate whether taking tocilizumab leads to less rejection, less development of unwanted antibodies, and better heart function.
Primary Outcome
This outcome is defined by a composite 1 year post-transplant endpoint of: * detection of de novo donor-specific antibodies (dnDSA) (Core Laboratory), * acute cellular rejection (ACR) ≥ ISHLT 2R rejection (Core Laboratory), * antibody mediated rejection (AMR) ≥ ISHLT AMR 1 (Core Laboratory), * hemodynamic compromise rejection in the absence of a biopsy or histological rejection, * death, or * re-transplantation.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL tocilizumab
- DRUG Standard of Care Triple IS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 385 participants |
| Start Date | 2018-12-20 |
| Est. Completion | 2025-03-25 |
| Phase | Phase 2 |
What the finished NCT03644667 record still lists
NCT03644667 is an interventional study that assigns participants to a tested intervention. The registered 385 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (189% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03644667 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03644667 about?
NCT03644667 is a clinical study titled "Tocilizumab in Cardiac Transplantation". The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Specifically, the investigators will evaluate whether taking tocilizumab leads to les...
What is the current status of trial NCT03644667?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 385 participants. The study started on 2018-12-20. Estimated completion is 2025-03-25.
What interventions are being tested in trial NCT03644667?
The interventions under investigation include: Placebo (BIOLOGICAL), tocilizumab (BIOLOGICAL), Standard of Care Triple IS (DRUG).
Who is sponsoring clinical trial NCT03644667?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03644667's enrollment target sits among peer trials
385 109th of 2000 higher than 1,890 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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