An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access

NCT01806545 | Completed Phase 2 Results DMC

• 1 other identifier: AVF01-SRM003
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 47

Brief Summary

A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis access. It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin matrix containing endothelial cells can provide a continuous supply of multiple growth regulatory compounds to the underlying cells within the blood vessel, while being protected from the effects of blood flow in the vessel(s) or complications resulting from being in direct contact with the point of injury.

Conditions

Arteriovenous Fistula

Keywords

Arteriovenous Fistula Surgery; Vascular Injury; Hemodialysis Access

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Arteriovenous Fistula (AVF) Maturation by Week 12 Visit Based on Hemodialysis or Color-flow Doppler Ultrasound (CDUS) And Vascular Access Examination

  Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 12 visit without assessment of maturity were considered treatment failures.

  12 weeks after surgery

Secondary Outcomes (8)

• Percentage of Participants With AVF Maturation by Week 26 Visit Based on Hemodialysis or CDUS And Vascular Access Examination

  26 weeks after surgery

• Time to AVF Maturation Based on Hemodialysis or CDUS and Vascular Access Examination

  Up to 26 weeks after surgery

• Percentage of Participants With Loss of Unassisted Primary Patency

  Up to 26 weeks after surgery

• Percentage of Participants With Loss of Assisted Primary Patency

  Up to 26 weeks after surgery

• Percentage of Participants With Loss of Secondary Patency

  Up to 26 weeks after surgery

Study Arms (2)

SRM003

ACTIVE COMPARATOR

One time implant (2 SRM003 pieces) on surgery day. Post-surgery, up to 26 weeks follow-up for assessment of efficacy/safety.

Biological: SRM003

Participating Site's standard practice

OTHER

Subjects will receive sites' standard practice treatment during the surgical procedure.

Other: Participating Site's standard practice

Interventions

SRM003 BIOLOGICAL

One time implant (2 SRM003 pieces) on surgery day.

Also known as: Allogeneic human aortic endothelial cells cultured in a gelatin matrix (Gelfoam®).

SRM003

Participating Site's standard practice OTHER

Subjects will receive sites' standard practice treatment during the surgical procedure.

Participating Site's standard practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be 18 years of age or older at the time of signing and dating informed consent (no upper age limit), can be male or female.
• Subject who is of child bearing potential must agree to use adequate contraception for 6 months after randomization.
• Subject must be currently undergoing hemodialysis or anticipating the start of hemodialysis and must require a new permanent, suitable access for the AVF creation in the upper extremity.
• Subject must have a life expectancy of at least 26 weeks after randomization.
• Subject must be able to understand and be willing to complete all study requirements.

You may not qualify if:

• Subject is currently on an active organ transplant list from a deceased donor or is undergoing assessment and expects to be placed on the active organ or bone marrow transplant list within the next 26 weeks from surgery, or expects to receive a living donor organ or bone marrow within the next 26 weeks and is unwilling to change transplant list status to "hold" for 3 months after randomization.
• Subject has had more than 1 access placement surgery (defined as a new access, not a revision) in the target limb.
• Subject has medical conditions and diseases that may cause non-compliance with the protocol
• Subject has a known allergy to bovine/porcine products or collagen/gelatin products.
• Subject has a history of intravenous drug use within 6 months prior to screening
• Subject is morbidly obese, defined as having a body mass index \>40.
• Pregnant or nursing woman, or plans to become pregnant during the study.

Sponsors & Collaborators

• Shire: lead

Study Sites (47)

Akdhc Medical Research Services

Phoenix, Arizona, 85012, United States

Location

Tucson Vascular Consultants

Tucson, Arizona, 85745, United States

Location

Ladenheim Dialysis Access Center

Fresno, California, 93710, United States

Location

California Institute of Renal Research

La Mesa, California, 91942, United States

Location

VA Long Beach Health Care System Pharmacy

Long Beach, California, 90822, United States

Location

The Regents University of California Los Angeles

Los Angeles, California, 90025, United States

Location

California Institute of Renal Research

San Diego, California, 92123, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520-8042, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Illinois Kidney Disease & Hypertension Center

Peoria, Illinois, 61603, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Ochsner Baptist Medical Center, Clinical Trials Unit

New Orleans, Louisiana, 70115, United States

Location

Louisiana State University Health Science Center Shreveport

Shreveport, Louisiana, 71130, United States

Location

Baystate Medical Center Pharmacy

Springfield, Massachusetts, 01199, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Renaissance Renal Research Institute, LLC

Detroit, Michigan, 48236, United States

Location

McLaren Northern Michigan Hospital-NISUS Research

Petoskey, Michigan, 49770, United States

Location

Providence Hospital, Research Dept.

Southfield, Michigan, 48075, United States

Location

Clinical Research Consultants, LLC

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Sierra Nevada Nephrology Consultants

Reno, Nevada, 89511, United States

Location

United Health Services

Johnson City, New York, 13790, United States

Location

Mount Sinai School of Medicine Lab

New York, New York, 10029, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Metrolina Nephrology Associates, PA

Charlotte, North Carolina, 28204, United States

Location

ECU Department of Nephrology and Hypertension

Greenville, North Carolina, 27834, United States

Location

Sanford Research/USD-Fargo

Fargo, North Dakota, 58122, United States

Location

University of Cincinnati Physicians Company

Cincinnati, Ohio, 45267, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Toledo Hospital

Toledo, Ohio, 43560, United States

Location

Kaiser Permanente Northwest

Milwaukie, Oregon, 97267, United States

Location

Northwest Renal Clinic, Inc.

Portland, Oregon, 97210, United States

Location

Penn Medicine, Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Delaware Valley Nephrology and Hypertension Associates, PC

Philadelphia, Pennsylvania, 19118, United States

Location

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

SC Nephrology & Hypertension Center, Inc.

Orangeburg, South Carolina, 29118, United States

Location

Erlanger Hospital Pharmacy

Chattanooga, Tennessee, 37403, United States

Location

Nephrology Associates, P.C.

Nashville, Tennessee, 37205, United States

Location

Baylor College of Medicine ICTR

Houston, Texas, 77030, United States

Location

Fletcher Allen Health Care Renal Service

Burlington, Vermont, 05401, United States

Location

Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Arteriovenous Fistula; Vascular System Injuries

Interventions

Gelatin Sponge, Absorbable

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Sponges; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 7, 2013
• Study Start: March 26, 2013
• Primary Completion: October 27, 2014
• Study Completion: October 27, 2014
• Last Updated: June 8, 2021
• Results First Posted: December 24, 2015

Record last verified: 2021-05

Locations

US (47)