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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01806545
First received: March 5, 2013
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Arteriovenous Fistula
Biological: SRM003
Other: Participating Site's standard practice
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Phase 2, Single-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy and Safety of SRM003 (Vascugel®) in Improving the Rate of Arteriovenous Fistula Maturation and Use in Subjects Undergoing Surgery for Creation of an Arteriovenous Fistula for Hemodialysis Access

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • To compare the time to arteriovenous fistula maturation for arteriovenous fistulas treated with SRM003 with those treated with participating sites' standard practice. [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare the overall duration of patency for AVFs treated with SRM003 with that for AVFs treated with participating sites' standard practice. [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 192
Study Start Date: March 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SRM003
One time implant (2 SRM003 pieces) on surgery day. Post-surgery, up to 26 weeks follow-up for assessment of efficacy/safety.
Biological: SRM003
One time implant (2 SRM003 pieces) on surgery day.
Other Name: Allogeneic human aortic endothelial cells cultured in a gelatin matrix (Gelfoam®).
Participating Site's standard practice
Subjects will receive sites' standard practice treatment during the surgical procedure.
Other: Participating Site's standard practice
Subjects will receive sites' standard practice treatment during the surgical procedure.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subject who is of child bearing potential must agree to use adequate contraception for 6 months after randomization.
  3. 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.
  4. Subject must have a life expectancy of at least 26 weeks after randomization.
  5. Subject must be able to understand and be willing to complete all study requirements.

Exclusion Criteria:

  1. 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.
  2. Subject has had more than 1 access placement surgery (defined as a new access, not a revision) in the target limb.
  3. Subject has medical conditions and diseases that may cause non-compliance with the protocol
  4. Subject has a known allergy to bovine/porcine products or collagen/gelatin products.
  5. Subject has a history of intravenous drug use within 6 months prior to screening
  6. Subject is morbidly obese, defined as having a body mass index >40.
  7. Pregnant or nursing woman, or plans to become pregnant during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806545

  Hide Study Locations
Locations
United States, Arizona
Akdhc Medical Research Services
Phoenix, Arizona, United States, 85012
Tucson Vascular Consultants
Tucson, Arizona, United States, 85745
United States, California
Ladenheim Dialysis Access Center
Fresno, California, United States, 93710
California Institute of Renal Research
La Mesa, California, United States, 91942
VA Long Beach Health Care System Pharmacy
Long Beach, California, United States, 90822
The Regents University of California Los Angeles
Los Angeles, California, United States, 90025
California Institute of Renal Research
San Diego, California, United States, 92123
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8042
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Illinois
Illinois Kidney Disease & Hypertension Center
Peoria, Illinois, United States, 61603
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Baptist Medical Center, Clinical Trials Unit
New Orleans, Louisiana, United States, 70115
Louisiana State University Health Science Center Shreveport
Shreveport, Louisiana, United States, 71130
United States, Massachusetts
Baystate Medical Center Pharmacy
Springfield, Massachusetts, United States, 01199
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Renaissance Renal Research Institute, LLC
Detroit, Michigan, United States, 48236
McLaren Northern Michigan Hospital-NISUS Research
Petoskey, Michigan, United States, 49770
Providence Hospital, Research Dept.
Southfield, Michigan, United States, 48075
United States, Missouri
Clinical Research Consultants, LLC
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nevada
Sierra Nevada Nephrology Consultants
Reno, Nevada, United States, 89511
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United Health Services
Johnson City, New York, United States, 13790
Mount Sinai School of Medicine Lab
New York, New York, United States, 10029
United States, North Carolina
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, United States, 28204
ECU Department of Nephrology and Hypertension
Greenville, North Carolina, United States, 27834
United States, North Dakota
Sanford Research/USD-Fargo
Fargo, North Dakota, United States, 58122
United States, Ohio
University of Cincinnati Physicians Company
Cincinnati, Ohio, United States, 45267
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Ohio State University
Columbus, Ohio, United States, 43210
Toledo Hospital
Toledo, Ohio, United States, 43560
United States, Oregon
Kaiser Permanente Northwest
Milwaukie, Oregon, United States, 97267
Northwest Renal Clinic, Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
Temple University School of Medicine
Philadelphia, Pennsylvania, United States, 19140
Penn Medicine, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Delaware Valley Nephrology and Hypertension Associates, PC
Philadelphia, Pennsylvania, United States, 19118
United States, South Carolina
SC Nephrology & Hypertension Center, Inc.
Orangeberg, South Carolina, United States, 29118
United States, Tennessee
Erlanger Hospital Pharmacy
Chattanooga, Tennessee, United States, 37403
Nephrology Associates, P.C.
Nashville, Tennessee, United States, 37205
United States, Texas
Baylor College of Medicine ICTR
Houston, Texas, United States, 77030
United States, Vermont
Fletcher Allen Health Care Renal Service
Burlington, Vermont, United States, 05401
United States, Virginia
Sentara Vascular Specialists
Norfolk, Virginia, United States, 23507
United States, Washington
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Steven Steinberg California Institute of Renal Research
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01806545     History of Changes
Other Study ID Numbers: AVF01-SRM003
Study First Received: March 5, 2013
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
Arteriovenous Fistula Surgery
Vascular Injury
Hemodialysis Access

Additional relevant MeSH terms:
Arteriovenous Fistula
Fistula
Arteriovenous Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical
Vascular Diseases
Vascular Fistula
Vascular Malformations

ClinicalTrials.gov processed this record on October 23, 2014