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 currently recruiting participants.
Verified March 2014 by Shire
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01806545
First received: March 5, 2013
Last updated: March 3, 2014
Last verified: March 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: December 2014
Estimated Primary Completion Date: June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01806545

Contacts
Contact: Jack Van Loon 1 (858) 754-5720 jvanloon@shire.com

  Show 48 Study Locations
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: March 3, 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
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 15, 2014