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

End Stage Renal Disease Clinical Trial

— ACCESS2  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05425056
• Other study ID #: VT-305
• Status: Recruiting
• Phase: Phase 3
• Start date: August 26, 2022
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: Vascular Therapies, Inc.
• Contact: Rakesh Raghubanshi
• Phone: 201-266-8310
• Email: rakesh[@]vascualrtx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Chronic Kidney Failure
• Complication of Hemodialysis
• Complication of Renal Dialysis
• End Stage Kidney Disease
• End Stage Renal Disease
• ESRD
• Fistula
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Vascular Access Complication

Intervention

Drug:
• Sirolimus
SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.

Locations

Country	Name	City	State
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow
United Kingdom	Barts Health NHS Trust of Royal London Hospital	London
United Kingdom	St George's University Hospitals NHS Foundation Trust	London
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	The Brigham and Women's Hospital	Boston	Massachusetts
United States	Atrium Health	Charlotte	North Carolina
United States	Surgical Specialists of Charlotte	Charlotte	North Carolina
United States	Arteries & Veins	El Paso	Texas
United States	Houston Methodist	Houston	Texas
United States	University of Louisville	Louisville	Kentucky
United States	James Eric Gardner, MD PC	Memphis	Tennessee
United States	American Access Care of Miami	Miami	Florida
United States	Yale University	New Haven	Connecticut
United States	Mount Sinai Hospital	New York	New York
United States	Sentara Norfolk General Hospital/Sentara Health Research Center	Norfolk	Virginia
United States	The Regional Medical Center/Dialysis Access Institute	Orangeburg	South Carolina
United States	Veterans Affairs San Diego Health Center	San Diego	California
United States	Houston Methodist	Sugar Land	Texas
United States	Lundquist Institute for Biomedical Innovation	Torrance	California
United States	MedStar Cardiovascular Research Network at MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Therapies, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Fistula Maturation (FM)	Clinical Fistula Maturation (FM) is defined as a fistula that can be cannulated with 2-needles for at least 75% of the dialysis sessions, including 3 consecutive sessions with a mean Qb of 300 mL/min (unless the prescribed Qb is <300 mL/min) performed during any continuous 30 day period that commences no later than 180 days after randomization.; The primary endpoint will be summarized as a time-to-event endpoint for the SeCI (Sirogen) and control groups by reporting the cumulative proportion of AVF that achieve FM over time [defined as the interval from access placement to the first session that the fistula can be cannulated with 2 needles (contributing to the FM definition)].	6 Months