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NCT01806584 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access
A Phase 2 study, sponsored by Shire.
- Terminated
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT01806584 is a Phase 2 study that was terminated before completion, run by Shire. The registered enrollment target is 32 participants.
The verdict
NCT01806584, a Phase 2 study, was terminated before completion, sponsored by Shire.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in extending the duration of primary patency after arteriovenous graft surgery in subjects with end-stage renal disease. It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin matrix containing endothelial cells can provide a continuous supply of multiple growth regulatory compounds to the underlying cells within the blood vessel, while being protected from the effects of blood flow in the vessel(s) or complications resulting from being in direct contact with the point of injury.
Interventions
- BIOLOGICAL SRM003
- OTHER Participating Site's standard practice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2013-03-28 |
| Est. Completion | 2014-10-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01806584
The ClinicalTrials.gov registry entry for NCT01806584 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SRM003 is the first listed.
NCT01806584 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01806584 about?
NCT01806584 is a clinical study titled "An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access". A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in extending the duration of primary patency after arteriovenous graft surgery in subjects with end-stage renal disease. It is hypothesized that when placed outside the blood vessel, the see...
What is the current status of trial NCT01806584?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2013-03-28. Estimated completion is 2014-10-23.
What interventions are being tested in trial NCT01806584?
The interventions under investigation include: SRM003 (BIOLOGICAL), Participating Site's standard practice (OTHER).
Who is sponsoring clinical trial NCT01806584?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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