Completed

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

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What is being tested

SRM003

+ Participating Site's standard practice

BiologicalOther
Who is being recruted

Congenital Abnormalities+11

+ Arteriovenous Malformations

+ Cardiovascular Diseases

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorShire
Last updated: June 8, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: March 26, 2013

Actual date on which the first participant was enrolled.

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.

NCT01806545
Principal SponsorShire
Last updated: June 8, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

64 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesArteriovenous MalformationsCardiovascular DiseasesFistulaCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathological Conditions, Signs and SymptomsVascular DiseasesWounds and InjuriesVascular FistulaCardiovascular AbnormalitiesPathological Conditions, AnatomicalVascular MalformationsArteriovenous FistulaVascular System Injuries

Criteria

5 inclusion criteria required to participate
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 must be able to understand and be willing to complete all study requirements
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
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7 exclusion criteria prevent from participating
Pregnant or nursing woman, or plans to become pregnant during the study
Subject has a history of intravenous drug use within 6 months prior to screening
Subject has a known allergy to bovine/porcine products or collagen/gelatin products
Subject has had more than 1 access placement surgery (defined as a new access, not a revision) in the target limb
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 47 locations

Akdhc Medical Research Services

Phoenix, United StatesOpen Akdhc Medical Research Services in Google Maps

Tucson Vascular Consultants

Tucson, United States

Ladenheim Dialysis Access Center

Fresno, United States

California Institute of Renal Research

La Mesa, United States
Completed47 Study Centers