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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Shire
- Enrollment
- 64
- Locations
- 47
- Primary Endpoint
- Percentage of Participants With Arteriovenous Fistula (AVF) Maturation by Week 12 Visit Based on Hemodialysis or Color-flow Doppler Ultrasound (CDUS) And Vascular Access Examination
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Subject who is of child bearing potential must agree to use adequate contraception for 6 months after randomization.
- •Subject must be currently undergoing hemodialysis or anticipating the start of hemodialysis and must require a new permanent, suitable access for the AVF creation in the upper extremity.
- •Subject must have a life expectancy of at least 26 weeks after randomization.
- •Subject must be able to understand and be willing to complete all study requirements.
Exclusion Criteria
- •Subject is currently on an active organ transplant list from a deceased donor or is undergoing assessment and expects to be placed on the active organ or bone marrow transplant list within the next 26 weeks from surgery, or expects to receive a living donor organ or bone marrow within the next 26 weeks and is unwilling to change transplant list status to "hold" for 3 months after randomization.
- •Subject has had more than 1 access placement surgery (defined as a new access, not a revision) in the target limb.
- •Subject has medical conditions and diseases that may cause non-compliance with the protocol
- •Subject has a known allergy to bovine/porcine products or collagen/gelatin products.
- •Subject has a history of intravenous drug use within 6 months prior to screening
- •Subject is morbidly obese, defined as having a body mass index >
- •Pregnant or nursing woman, or plans to become pregnant during the study.
Arms & Interventions
Participating Site's standard practice
Subjects will receive sites' standard practice treatment during the surgical procedure.
Intervention: Participating Site's standard practice (Other)
SRM003
One time implant (2 SRM003 pieces) on surgery day. Post-surgery, up to 26 weeks follow-up for assessment of efficacy/safety.
Intervention: SRM003 (Biological)
Outcomes
Primary Outcomes
Percentage of Participants With Arteriovenous Fistula (AVF) Maturation by Week 12 Visit Based on Hemodialysis or Color-flow Doppler Ultrasound (CDUS) And Vascular Access Examination
Time Frame: 12 weeks after surgery
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.
Secondary Outcomes
- Percentage of Participants With AVF Maturation by Week 26 Visit Based on Hemodialysis or CDUS And Vascular Access Examination(26 weeks after surgery)
- Time to AVF Maturation Based on Hemodialysis or CDUS and Vascular Access Examination(Up to 26 weeks after surgery)
- Percentage of Participants With Loss of Unassisted Primary Patency(Up to 26 weeks after surgery)
- Percentage of Participants With Loss of Assisted Primary Patency(Up to 26 weeks after surgery)
- Percentage of Participants With Loss of Secondary Patency(Up to 26 weeks after surgery)
- Change From Week 1 in Average Vascular Access Lumen Diameter Using CDUS(1, 12, and 26 weeks after surgery)
- Percentage of Participants With Clinical Success Based on First Use of The Study AVF For Hemodialysis(12 and 26 weeks after surgery)
- Number of Interventions to Establish, Maintain, or Restore Patency(12 and 26 weeks after surgery)