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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: Clinical Trial Phase 2 study, sponsored by Shire.
NCT01806584 is a Phase 2 study that was terminated before completion, run by Shire. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (arteriovenous graft \[AVG\] placement) until the first date of (a) any intervention designed to establish, maintain, or restore patency, (b) occlusion (commonly due to thrombosis), or (c) access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject's AVG at each visit and through ongoing AVG monitoring and surveillan
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 |
Why NCT01806584 stopped before completion
NCT01806584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 2 interventions - of which SRM003 is the first listed.
NCT01806584 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01806584's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 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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