Clinical trial NCT01806545: An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arteriovenous Fistula
Keywords: Arteriovenous Fistula Surgery
Vascular Injury
Hemodialysis Access
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-03-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Arteriovenous Fistula (AVF) Maturation by Week 12 Visit Based on Hemodialysis or Color-flow Doppler Ultrasound (CDUS) And Vascular Access Examination
timeFrame: 12 weeks after surgery
Secondary outcomes:
measure: Percentage of Participants With AVF Maturation by Week 26 Visit Based on Hemodialysis or CDUS And Vascular Access Examination
timeFrame: 26 weeks after surgery
measure: Time to AVF Maturation Based on Hemodialysis or CDUS and Vascular Access Examination
timeFrame: Up to 26 weeks after surgery
measure: Percentage of Participants With Loss of Unassisted Primary Patency
timeFrame: Up to 26 weeks after surgery
measure: Percentage of Participants With Loss of Assisted Primary Patency
timeFrame: Up to 26 weeks after surgery
measure: Percentage of Participants With Loss of Secondary Patency
timeFrame: Up to 26 weeks after surgery
measure: Change From Week 1 in Average Vascular Access Lumen Diameter Using CDUS
timeFrame: 1, 12, and 26 weeks after surgery
measure: Percentage of Participants With Clinical Success Based on First Use of The Study AVF For Hemodialysis
timeFrame: 12 and 26 weeks after surgery
measure: Number of Interventions to Establish, Maintain, or Restore Patency
timeFrame: 12 and 26 weeks after surgery
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Akdhc Medical Research Services
state: Arizona
city: Tucson
country: United States
facility: Tucson Vascular Consultants
state: Arizona
city: Fresno
country: United States
facility: Ladenheim Dialysis Access Center
state: California
city: La Mesa
country: United States
facility: California Institute of Renal Research
state: California
city: Long Beach
country: United States
facility: VA Long Beach Health Care System Pharmacy
state: California
city: Los Angeles
country: United States
facility: The Regents University of California Los Angeles
state: California
city: San Diego
country: United States
facility: California Institute of Renal Research
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Peoria
country: United States
facility: Illinois Kidney Disease & Hypertension Center
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Baptist Medical Center, Clinical Trials Unit
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Science Center Shreveport
state: Louisiana
city: Springfield
country: United States
facility: Baystate Medical Center Pharmacy
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Renaissance Renal Research Institute, LLC
state: Michigan
city: Petoskey
country: United States
facility: McLaren Northern Michigan Hospital-NISUS Research
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital, Research Dept.
state: Michigan
city: Kansas City
country: United States
facility: Clinical Research Consultants, LLC
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Reno
country: United States
facility: Sierra Nevada Nephrology Consultants
state: Nevada
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Johnson City
country: United States
facility: United Health Services
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine Lab
state: New York
city: Charlotte
country: United States
facility: Metrolina Nephrology Associates, PA
state: North Carolina
city: Greenville
country: United States
facility: ECU Department of Nephrology and Hypertension
state: North Carolina
city: Fargo
country: United States
facility: Sanford Research/USD-Fargo
state: North Dakota
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians Company
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Toledo
country: United States
facility: Toledo Hospital
state: Ohio
city: Milwaukie
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
city: Portland
country: United States
facility: Northwest Renal Clinic, Inc.
state: Oregon
city: Philadelphia
country: United States
facility: Penn Medicine, Perelman Center for Advanced Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Delaware Valley Nephrology and Hypertension Associates, PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University School of Medicine
state: Pennsylvania
city: Orangeburg
country: United States
facility: SC Nephrology & Hypertension Center, Inc.
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Hospital Pharmacy
state: Tennessee
city: Nashville
country: United States
facility: Nephrology Associates, P.C.
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine ICTR
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care Renal Service
state: Vermont
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: