A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery (ACCESS2)

Vascular Therapies, Inc.

Status and phase: Active, not recruiting; Phase 3

Conditions: Chronic Kidney Failure; Complication of Hemodialysis; Complication of Renal Dialysis; Vascular Access Complication; ESRD; End Stage Renal Disease; End Stage Kidney Disease; Arteriovenous Fistula

Treatments: Drug: Sirolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT05425056

VT-305

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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136 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

Subjects randomized to the treatment arm will undergo AV fistula surgery and will receive the Sirolimus eluting Collagen Implant (SeCI).

Treatment:

Drug: Sirolimus

Control Arm

No Intervention group

Description:

Subjects randomized to the control arm will undergo AV fistula surgery alone and will not receive an implant.