A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
Purpose
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access.
Conditions
- Complication of Renal Dialysis
- End Stage Renal Disease
- End Stage Kidney Disease
- ESRD
- Chronic Kidney Failure
- Complication of Hemodialysis
- Vascular Access Complication
- Arteriovenous Fistula
Eligibility
- Eligible Ages
- Over 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age 65 years or older - Currently on hemodialysis for ≤12 months - Successful creation of a single stage radiocephalic end to side fistula
Exclusion Criteria
- Prior AV access created on the limb where the fistula surgery is planned - Planned start of peritoneal dialysis within 6 months of randomization - Known hypersensitivity to the following: sirolimus, beef or bovine collagen - Known to be HIV positive - Prisoner, mentally incompetent, and/or current alcohol or drug abuser
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment Arm |
Subjects randomized to the treatment arm will undergo AV fistula surgery and will receive the Sirolimus eluting Collagen Implant (SeCI). |
|
|
No Intervention Control Arm |
Subjects randomized to the control arm will undergo AV fistula surgery alone and will not receive an implant. |
|
Recruiting Locations
Washington, District of Columbia 20010
S Singh
More Details
- Status
- Recruiting
- Sponsor
- Vascular Therapies, Inc.
Detailed Description
This is a Phase 3, multicenter, randomized, single-blind, controlled, study designed to evaluate the efficacy and safety of the use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects who are on hemodialysis and are undergoing surgical creation of an AV fistula in comparison to subjects who do not receive the implant. Subjects of either gender, who are at least 65 years of age, undergoing hemodialysis, and require a new single stage radiocephalic end to side fistula will be eligible to participate in this study. Subjects who meet eligibility criteria and undergo successful AV fistula creation will be eligible for enrollment. The study plans to enroll approximately 120 subjects, randomized in a 1:1 ratio. Enrolled subjects will be followed for a period of one year from the time of their index surgical procedure.