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: April 22, 2014
Last verified: April 2014

March 5, 2013
April 22, 2014
March 2013
June 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01806545 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Arteriovenous Fistula
  • Biological: SRM003
    One time implant (2 SRM003 pieces) on surgery day.
    Other Name: Allogeneic human aortic endothelial cells cultured in a gelatin matrix (Gelfoam®).
  • Other: Participating Site's standard practice
    Subjects will receive sites' standard practice treatment during the surgical procedure.
  • 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.
    Intervention: Biological: SRM003
  • Participating Site's standard practice
    Subjects will receive sites' standard practice treatment during the surgical procedure.
    Intervention: Other: Participating Site's standard practice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
192
December 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01806545
AVF01-SRM003
Yes
Shire
Shire
Not Provided
Principal Investigator: Steven Steinberg California Institute of Renal Research
Shire
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP