Clinical trial NCT05425056: A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
Official title: A Phase 3, Prospective, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus Eluting Collagen Implant (The ACCESS 2 Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
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
Keywords: Arteriovenous Fistula
Hemodialysis vascular access
Dialysis fistula
Dialysis access
Lead sponsor: Vascular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 136
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Fistula Maturation (FM)
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Veterans Affairs San Diego Health Center
state: California
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation
state: California
city: Washington
country: United States
facility: MedStar Cardiovascular Research Network at MedStar Washington Hospital Center
state: District of Columbia
city: Miami
country: United States
facility: American Access Care of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Boston
country: United States
facility: The Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Charlotte
country: United States
facility: Surgical Specialists of Charlotte
state: North Carolina
city: Orangeburg
country: United States
facility: The Regional Medical Center/Dialysis Access Institute
state: South Carolina
city: Memphis
country: United States
facility: James Eric Gardner, MD PC
state: Tennessee
city: El Paso
country: United States
facility: Arteries & Veins
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Sugar Land
country: United States
facility: Houston Methodist
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital/Sentara Health Research Center
state: Virginia
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Carshalton
country: United Kingdom
facility: St Helier Hospital
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: London
country: United Kingdom
facility: Barts Health NHS Trust of Royal London Hospital
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
Study officials:
affiliation: Vascular Therapies, Inc.
name: Sriram Iyer, MD
role: STUDY_DIRECTOR
References: