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NCT01806545 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT01806545 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 64 participants.
The verdict
NCT01806545, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis access. 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 | 64 participants |
| Start Date | 2013-03-26 |
| Est. Completion | 2014-10-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01806545
The ClinicalTrials.gov registry entry for NCT01806545 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 64 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.
NCT01806545 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01806545 about?
NCT01806545 is a clinical study titled "An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access". A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis access. It is hypothesized that ...
What is the current status of trial NCT01806545?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2013-03-26. Estimated completion is 2014-10-27.
What interventions are being tested in trial NCT01806545?
The interventions under investigation include: SRM003 (BIOLOGICAL), Participating Site's standard practice (OTHER).
Who is sponsoring clinical trial NCT01806545?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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