Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01806545 | An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access | PHASE2 | COMPLETED | 64 | — | — | Mar 26, 2013 | Oct 27, 2014 | Jun 8, 2021 | 47 | United States |
Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 12 visit without assessment of maturity were considered treatment failures.
| Arm | Type | Description |
|---|---|---|
| SRM003 | ACTIVE_COMPARATOR | One time implant (2 SRM003 pieces) on surgery day. Post-surgery, up to 26 weeks follow-up for assessment of efficacy/safety. |
| Participating Site's standard practice | OTHER | Subjects will receive sites' standard practice treatment during the surgical procedure. |
| Name | Type | Description |
|---|---|---|
| SRM003 | BIOLOGICAL | One time implant (2 SRM003 pieces) on surgery day. |
| Participating Site's standard practice | OTHER | Subjects will receive sites' standard practice treatment during the surgical procedure. |
Inclusion Criteria: 1. Subject must be 18 years of age or older at the time of signing and dating informed consent (no upper age limit), can be male or female. 2. Subject who is of child bearing potential must agree to use adequate contraception for 6 months after randomization. 3. Subject must be ...