An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access
Public ClinicalTrials.gov record NCT01806545. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Single-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy and Safety of SRM003 (Vascugel®) in Improving the Rate of Arteriovenous Fistula Maturation and Use in Subjects Undergoing Surgery for Creation of an Arteriovenous Fistula for Hemodialysis Access
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01806545
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 64 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 26, 2013 (Actual)
- Primary completion
- Oct 27, 2014 (Actual)
- Completion
- Oct 27, 2014 (Actual)
- Last update posted
- Jun 8, 2021
2013 – 2014
United States locations
- U.S. sites
- 47
- U.S. states
- 26
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Akdhc Medical Research Services | Phoenix | Arizona | 85012 | — |
| Tucson Vascular Consultants | Tucson | Arizona | 85745 | — |
| Ladenheim Dialysis Access Center | Fresno | California | 93710 | — |
| California Institute of Renal Research | La Mesa | California | 91942 | — |
| VA Long Beach Health Care System Pharmacy | Long Beach | California | 90822 | — |
| The Regents University of California Los Angeles | Los Angeles | California | 90025 | — |
| California Institute of Renal Research | San Diego | California | 92123 | — |
| University of California, San Francisco | San Francisco | California | 94143 | — |
| University of Colorado Denver | Aurora | Colorado | 80045 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06520-8042 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Georgia Regents University | Augusta | Georgia | 30912 | — |
| Illinois Kidney Disease & Hypertension Center | Peoria | Illinois | 61603 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Ochsner Baptist Medical Center, Clinical Trials Unit | New Orleans | Louisiana | 70115 | — |
| Louisiana State University Health Science Center Shreveport | Shreveport | Louisiana | 71130 | — |
| Baystate Medical Center Pharmacy | Springfield | Massachusetts | 01199 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Renaissance Renal Research Institute, LLC | Detroit | Michigan | 48236 | — |
| McLaren Northern Michigan Hospital-NISUS Research | Petoskey | Michigan | 49770 | — |
| Providence Hospital, Research Dept. | Southfield | Michigan | 48075 | — |
| Clinical Research Consultants, LLC | Kansas City | Missouri | 64111 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Sierra Nevada Nephrology Consultants | Reno | Nevada | 89511 | — |
| United Health Services | Johnson City | New York | 13790 | — |
| Mount Sinai School of Medicine Lab | New York | New York | 10029 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Metrolina Nephrology Associates, PA | Charlotte | North Carolina | 28204 | — |
| ECU Department of Nephrology and Hypertension | Greenville | North Carolina | 27834 | — |
| Sanford Research/USD-Fargo | Fargo | North Dakota | 58122 | — |
| University of Cincinnati Physicians Company | Cincinnati | Ohio | 45267 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Toledo Hospital | Toledo | Ohio | 43560 | — |
| Kaiser Permanente Northwest | Milwaukie | Oregon | 97267 | — |
| Northwest Renal Clinic, Inc. | Portland | Oregon | 97210 | — |
| Penn Medicine, Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Delaware Valley Nephrology and Hypertension Associates, PC | Philadelphia | Pennsylvania | 19118 | — |
| Temple University School of Medicine | Philadelphia | Pennsylvania | 19140 | — |
| SC Nephrology & Hypertension Center, Inc. | Orangeburg | South Carolina | 29118 | — |
| Erlanger Hospital Pharmacy | Chattanooga | Tennessee | 37403 | — |
| Nephrology Associates, P.C. | Nashville | Tennessee | 37205 | — |
| Baylor College of Medicine ICTR | Houston | Texas | 77030 | — |
| Fletcher Allen Health Care Renal Service | Burlington | Vermont | 05401 | — |
| Sentara Vascular Specialists | Norfolk | Virginia | 23507 | — |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01806545, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 8, 2021 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01806545 live on ClinicalTrials.gov.