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

Sponsor

Vascular Therapies, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05425056

Collaborator

(none)

120

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complication of Renal Dialysis End Stage Renal Disease End Stage Kidney Disease ESRD Chronic Kidney Failure Complication of Hemodialysis Vascular Access Complication Arteriovenous Fistula	Drug: Sirolimus	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

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)

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm Subjects randomized to the treatment arm will undergo AV fistula surgery and will receive the Sirolimus eluting Collagen Implant (SeCI).	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. Other Names: Sirolimus-eluting Collagen Implant SeCI Sirogen
No Intervention: Control Arm Subjects randomized to the control arm will undergo AV fistula surgery alone and will not receive an implant.

Arm

Intervention/Treatment

Experimental: Treatment Arm

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

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.

Other Names:

Sirolimus-eluting Collagen Implant

SeCI

Sirogen

No Intervention: Control Arm

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

Outcome Measures

Primary Outcome Measures

Clinical Fistula Maturation (FM) [6 Months]
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)].

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Francisco	San Francisco	California	United States	94143
2	Lundquist Institute for Biomedical Innovation	Torrance	California	United States	90502
3	Yale University	New Haven	Connecticut	United States	06510
4	MedStar Cardiovascular Research Network at MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
5	Augusta University	Augusta	Georgia	United States	30912
6	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
7	University of Louisville	Louisville	Kentucky	United States	40202
8	Clinical Research Consultant, LLC	Kansas City	Missouri	United States	64111
9	Atrium Health	Charlotte	North Carolina	United States	28204
10	Surgical Specialists of Charlotte	Charlotte	North Carolina	United States	28207
11	Lehigh Valley Health Network	Allentown	Pennsylvania	United States	18103
12	Mcleod Health	Loris	South Carolina	United States	29569
13	The Regional Medical Center/Dialysis Access Institute	Orangeburg	South Carolina	United States	29118
14	HCA Houston Medical Center	Houston	Texas	United States	77004
15	Sentara Norfolk General Hospital/Sentara Health Research Center	Norfolk	Virginia	United States	23507