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

Primary Purpose

Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sirolimus
Sponsored by
Vascular Therapies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Complication of Renal Dialysis focused on measuring Arteriovenous Fistula, Hemodialysis vascular access, Dialysis fistula, Dialysis access

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Veterans Affairs San Diego Health CenterRecruiting
  • Lundquist Institute for Biomedical InnovationRecruiting
  • Yale UniversityRecruiting
  • MedStar Cardiovascular Research Network at MedStar Washington Hospital CenterRecruiting
  • Emory University Hospital MidtownRecruiting
  • Augusta UniversityRecruiting
  • University of LouisvilleRecruiting
  • The Brigham and Women's HospitalRecruiting
  • Mount Sinai HospitalRecruiting
  • Atrium HealthRecruiting
  • Surgical Specialists of CharlotteRecruiting
  • Lehigh Valley Health NetworkRecruiting
  • The Regional Medical Center/Dialysis Access InstituteRecruiting
  • James Eric Gardner, MD PCRecruiting
  • Houston MethodistRecruiting
  • Houston MethodistRecruiting
  • Sentara Norfolk General Hospital/Sentara Health Research CenterRecruiting
  • University Hospitals Birmingham NHS Foundation TrustRecruiting
  • NHS Greater Glasgow and ClydeRecruiting
  • Barts Health NHS Trust of Royal London HospitalRecruiting
  • St George's University Hospitals NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Arm

Control Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)].

Secondary Outcome Measures

Full Information

First Posted
June 10, 2022
Last Updated
September 23, 2023
Sponsor
Vascular Therapies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05425056
Brief Title
A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascular Therapies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Subjects randomized to the treatment arm will undergo AV fistula surgery and will receive the Sirolimus eluting Collagen Implant (SeCI).
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Subjects randomized to the control arm will undergo AV fistula surgery alone and will not receive an implant.
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
Sirolimus-eluting Collagen Implant, SeCI, Sirogen
Intervention Description
SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.
Primary Outcome Measure Information:
Title
Clinical Fistula Maturation (FM)
Description
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)].
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rakesh Raghubanshi
Phone
201-266-8310
Email
rakesh@vascualrtx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sriram Iyer, MD
Organizational Affiliation
Vascular Therapies, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Veterans Affairs San Diego Health Center
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A Romero
Facility Name
Lundquist Institute for Biomedical Innovation
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
E Hernandez
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrice Lauture
Facility Name
MedStar Cardiovascular Research Network at MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Singh
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Douglas
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C Smith
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L Haysley
Facility Name
The Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M Hussain
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Mccracken
Facility Name
Atrium Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M Myers
Facility Name
Surgical Specialists of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C Turner
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
T Eichelberger
Facility Name
The Regional Medical Center/Dialysis Access Institute
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
V Anderson
Facility Name
James Eric Gardner, MD PC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J Gardner
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Khan
Facility Name
Houston Methodist
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J Garrett
Facility Name
Sentara Norfolk General Hospital/Sentara Health Research Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Willis
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
N Inston
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
D Kingsmore
Facility Name
Barts Health NHS Trust of Royal London Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R Sivaprakasam
Facility Name
St George's University Hospitals NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R Brambilla

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) collected in this study will not be shared.

Learn more about this trial

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

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