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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05425056
Recruitment Status : Recruiting
First Posted : June 21, 2022
Last Update Posted : September 29, 2022
Sponsor:
Information provided by (Responsible Party):
Vascular Therapies, Inc.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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)
Actual Study Start Date : August 26, 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
Drug Information available for: Sirolimus

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.



Primary Outcome Measures :
  1. Clinical Fistula Maturation (FM) [ Time Frame: 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)].




Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05425056


Contacts
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Contact: Rakesh Raghubanshi 201-266-8310 rakesh@vascualrtx.com

Locations
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United States, California
University of California San Francisco Not yet recruiting
San Francisco, California, United States, 94143
Contact: L Menke         
Lundquist Institute for Biomedical Innovation Recruiting
Torrance, California, United States, 90502
Contact: E Hernandez         
United States, Connecticut
Yale University Not yet recruiting
New Haven, Connecticut, United States, 06510
Contact: Patrice Lauture         
United States, District of Columbia
MedStar Cardiovascular Research Network at MedStar Washington Hospital Center Not yet recruiting
Washington, District of Columbia, United States, 20010
Contact: S Singh         
United States, Georgia
Augusta University Not yet recruiting
Augusta, Georgia, United States, 30912
Contact: C Smith         
United States, Iowa
University of Iowa Hospitals and Clinics Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: J Pena-Quevedo         
United States, Kentucky
University of Louisville Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: L Haysley         
United States, Missouri
Clinical Research Consultant, LLC Not yet recruiting
Kansas City, Missouri, United States, 64111
Contact: M Al Ameer         
United States, North Carolina
Atrium Health Not yet recruiting
Charlotte, North Carolina, United States, 28204
Contact: M Myers         
Surgical Specialists of Charlotte Recruiting
Charlotte, North Carolina, United States, 28207
Contact: C Turner         
United States, Pennsylvania
Lehigh Valley Health Network Not yet recruiting
Allentown, Pennsylvania, United States, 18103
Contact: T Eichelberger         
United States, South Carolina
The Regional Medical Center/Dialysis Access Institute Not yet recruiting
Orangeburg, South Carolina, United States, 29118
Contact: V Anderson         
United States, Texas
HCA Houston Medical Center Not yet recruiting
Houston, Texas, United States, 77004
Contact: J Morrison         
United States, Virginia
Sentara Norfolk General Hospital/Sentara Health Research Center Not yet recruiting
Norfolk, Virginia, United States, 23507
Contact: S Willis         
Sponsors and Collaborators
Vascular Therapies, Inc.
Investigators
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Study Director: Sriram Iyer, MD Vascular Therapies, Inc.
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Responsible Party: Vascular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT05425056    
Other Study ID Numbers: VT-305
First Posted: June 21, 2022    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) collected in this study will not be shared.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vascular Therapies, Inc.:
Arteriovenous Fistula
Hemodialysis vascular access
Dialysis fistula
Dialysis access
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Arteriovenous Fistula
Fistula
Urologic Diseases
Pathological Conditions, Anatomical
Renal Insufficiency, Chronic
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs