Overview

This trial is active, not recruiting.

Condition arteriovenous fistula
Treatments srm003, participating site's standard practice
Phase phase 2
Sponsor Shire
Start date March 2013
End date October 2014
Trial size 192 participants
Trial identifier NCT01806545, AVF01-SRM003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
One time implant (2 SRM003 pieces) on surgery day. Post-surgery, up to 26 weeks follow-up for assessment of efficacy/safety.
srm003 Allogeneic human aortic endothelial cells cultured in a gelatin matrix (Gelfoam®).
One time implant (2 SRM003 pieces) on surgery day.
(Other)
Subjects will receive sites' standard practice treatment during the surgical procedure.
participating site's standard practice
Subjects will receive sites' standard practice treatment during the surgical procedure.

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Steven Steinberg
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Shire.