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An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access

Primary Purpose

Arteriovenous Fistula

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SRM003
Participating Site's standard practice
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arteriovenous Fistula focused on measuring Arteriovenous Fistula Surgery, Vascular Injury, Hemodialysis Access

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Akdhc Medical Research Services
  • Tucson Vascular Consultants
  • Ladenheim Dialysis Access Center
  • California Institute of Renal Research
  • VA Long Beach Health Care System Pharmacy
  • The Regents University of California Los Angeles
  • California Institute of Renal Research
  • University of California, San Francisco
  • University of Colorado Denver
  • Yale University School of Medicine
  • Tampa General Hospital
  • Georgia Regents University
  • Illinois Kidney Disease & Hypertension Center
  • University of Louisville
  • Ochsner Baptist Medical Center, Clinical Trials Unit
  • Louisiana State University Health Science Center Shreveport
  • Baystate Medical Center Pharmacy
  • Henry Ford Hospital
  • Renaissance Renal Research Institute, LLC
  • McLaren Northern Michigan Hospital-NISUS Research
  • Providence Hospital, Research Dept.
  • Clinical Research Consultants, LLC
  • Washington University School of Medicine
  • Sierra Nevada Nephrology Consultants
  • Montefiore Medical Center
  • United Health Services
  • Mount Sinai School of Medicine Lab
  • Metrolina Nephrology Associates, PA
  • ECU Department of Nephrology and Hypertension
  • Sanford Research/USD-Fargo
  • University of Cincinnati Physicians Company
  • The Cleveland Clinic Foundation
  • The Ohio State University
  • Toledo Hospital
  • Kaiser Permanente Northwest
  • Northwest Renal Clinic, Inc.
  • Penn Medicine, Perelman Center for Advanced Medicine
  • Delaware Valley Nephrology and Hypertension Associates, PC
  • Temple University School of Medicine
  • SC Nephrology & Hypertension Center, Inc.
  • Erlanger Hospital Pharmacy
  • Nephrology Associates, P.C.
  • Baylor College of Medicine ICTR
  • Fletcher Allen Health Care Renal Service
  • Sentara Vascular Specialists
  • Wenatchee Valley Medical Center
  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

SRM003

Participating Site's standard practice

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 12 visit without assessment of maturity were considered treatment failures.

Secondary Outcome Measures

Percentage of Participants With AVF Maturation by Week 26 Visit Based on Hemodialysis or CDUS And Vascular Access Examination
Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 26 visit without assessment of maturity were considered treatment failures.
Time to AVF Maturation Based on Hemodialysis or CDUS and Vascular Access Examination
Time to AVF maturation was defined as the duration of time (in days) from the date of randomization (AVF creation) to the date of maturation, where the date of maturation corresponds to the earlier of either the date of the first use of the study AVF for hemodialysis as determined by the investigator following discussion with the participant, or the date the AVF meets all of the following 3 criteria as determined through CDUS and vascular access examination: presence of bruit throughout systole and diastole at least 8 centimeters proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Participants who died, underwent a kidney transplant, or were either lost to follow-up or did not mature during the study follow-up were censored at the time of death, time of transplant, or time of last visit, respectively.
Percentage of Participants With Loss of Unassisted Primary Patency
The time to loss of unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) any intervention designed to establish, maintain, or restore patency; (b) occlusion (commonly due to thrombosis); or (c) access abandonment.
Percentage of Participants With Loss of Assisted Primary Patency
The time to loss of assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment.
Percentage of Participants With Loss of Secondary Patency
The time to loss of secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVF creation) until the date of access abandonment.
Change From Week 1 in Average Vascular Access Lumen Diameter Using CDUS
B-mode lumen diameter measurements were obtained in the outflow vein as 3 separate images for each location: at 1, 3, and 5 centimeter into the vein and from the toe of the venous anastomosis. The average of lumen diameter measurements obtained at 1, 3, and 5 cm from the anastomosis was used for this endpoint.
Percentage of Participants With Clinical Success Based on First Use of The Study AVF For Hemodialysis
Clinical success was defined as the ability to undergo hemodialysis using the AVF. The date of clinical success corresponded to the date of the first use of the study AVF for hemodialysis as determined by the investigator, following discussion with the subject. Clinical success was assessed in a continuous fashion and, once achieved, the AVF was considered a clinical success at that and all subsequent time points. The date of clinical success based on the first use of the AVF for hemodialysis was compared with the dates of each study visit (Week 12 and Week 26); for study visits occurring prior to the date of clinical success based on the first use of the AVF for hemodialysis, the subject was counted as a nonsuccess and for study visits occurring on or after the date of maturation based on the first use of the AVF for hemodialysis, the subject was counted as a success.
Number of Interventions to Establish, Maintain, or Restore Patency
The total number of interventions to establish, maintain, or restore patency was recorded for each participant.

Full Information

First Posted
March 5, 2013
Last Updated
May 14, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01806545
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 26, 2013 (Actual)
Primary Completion Date
October 27, 2014 (Actual)
Study Completion Date
October 27, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula
Keywords
Arteriovenous Fistula Surgery, Vascular Injury, Hemodialysis Access

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SRM003
Arm Type
Active Comparator
Arm Description
One time implant (2 SRM003 pieces) on surgery day. Post-surgery, up to 26 weeks follow-up for assessment of efficacy/safety.
Arm Title
Participating Site's standard practice
Arm Type
Other
Arm Description
Subjects will receive sites' standard practice treatment during the surgical procedure.
Intervention Type
Biological
Intervention Name(s)
SRM003
Other Intervention Name(s)
Allogeneic human aortic endothelial cells cultured in a gelatin matrix (Gelfoam®).
Intervention Description
One time implant (2 SRM003 pieces) on surgery day.
Intervention Type
Other
Intervention Name(s)
Participating Site's standard practice
Intervention Description
Subjects will receive sites' standard practice treatment during the surgical procedure.
Primary Outcome Measure Information:
Title
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
Description
Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 12 visit without assessment of maturity were considered treatment failures.
Time Frame
12 weeks after surgery
Secondary Outcome Measure Information:
Title
Percentage of Participants With AVF Maturation by Week 26 Visit Based on Hemodialysis or CDUS And Vascular Access Examination
Description
Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 26 visit without assessment of maturity were considered treatment failures.
Time Frame
26 weeks after surgery
Title
Time to AVF Maturation Based on Hemodialysis or CDUS and Vascular Access Examination
Description
Time to AVF maturation was defined as the duration of time (in days) from the date of randomization (AVF creation) to the date of maturation, where the date of maturation corresponds to the earlier of either the date of the first use of the study AVF for hemodialysis as determined by the investigator following discussion with the participant, or the date the AVF meets all of the following 3 criteria as determined through CDUS and vascular access examination: presence of bruit throughout systole and diastole at least 8 centimeters proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Participants who died, underwent a kidney transplant, or were either lost to follow-up or did not mature during the study follow-up were censored at the time of death, time of transplant, or time of last visit, respectively.
Time Frame
Up to 26 weeks after surgery
Title
Percentage of Participants With Loss of Unassisted Primary Patency
Description
The time to loss of unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) any intervention designed to establish, maintain, or restore patency; (b) occlusion (commonly due to thrombosis); or (c) access abandonment.
Time Frame
Up to 26 weeks after surgery
Title
Percentage of Participants With Loss of Assisted Primary Patency
Description
The time to loss of assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment.
Time Frame
Up to 26 weeks after surgery
Title
Percentage of Participants With Loss of Secondary Patency
Description
The time to loss of secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVF creation) until the date of access abandonment.
Time Frame
Up to 26 weeks after surgery
Title
Change From Week 1 in Average Vascular Access Lumen Diameter Using CDUS
Description
B-mode lumen diameter measurements were obtained in the outflow vein as 3 separate images for each location: at 1, 3, and 5 centimeter into the vein and from the toe of the venous anastomosis. The average of lumen diameter measurements obtained at 1, 3, and 5 cm from the anastomosis was used for this endpoint.
Time Frame
1, 12, and 26 weeks after surgery
Title
Percentage of Participants With Clinical Success Based on First Use of The Study AVF For Hemodialysis
Description
Clinical success was defined as the ability to undergo hemodialysis using the AVF. The date of clinical success corresponded to the date of the first use of the study AVF for hemodialysis as determined by the investigator, following discussion with the subject. Clinical success was assessed in a continuous fashion and, once achieved, the AVF was considered a clinical success at that and all subsequent time points. The date of clinical success based on the first use of the AVF for hemodialysis was compared with the dates of each study visit (Week 12 and Week 26); for study visits occurring prior to the date of clinical success based on the first use of the AVF for hemodialysis, the subject was counted as a nonsuccess and for study visits occurring on or after the date of maturation based on the first use of the AVF for hemodialysis, the subject was counted as a success.
Time Frame
12 and 26 weeks after surgery
Title
Number of Interventions to Establish, Maintain, or Restore Patency
Description
The total number of interventions to establish, maintain, or restore patency was recorded for each participant.
Time Frame
12 and 26 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 who is of child bearing potential must agree to use adequate contraception for 6 months after randomization. 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. Subject must be able to understand and be willing to complete all study requirements. Exclusion Criteria: 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. Subject has had more than 1 access placement surgery (defined as a new access, not a revision) in the target limb. Subject has medical conditions and diseases that may cause non-compliance with the protocol Subject has a known allergy to bovine/porcine products or collagen/gelatin products. Subject has a history of intravenous drug use within 6 months prior to screening Subject is morbidly obese, defined as having a body mass index >40. Pregnant or nursing woman, or plans to become pregnant during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Akdhc Medical Research Services
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Tucson Vascular Consultants
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Ladenheim Dialysis Access Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
California Institute of Renal Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
VA Long Beach Health Care System Pharmacy
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
The Regents University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
California Institute of Renal Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8042
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Illinois Kidney Disease & Hypertension Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Baptist Medical Center, Clinical Trials Unit
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Louisiana State University Health Science Center Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Baystate Medical Center Pharmacy
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Renaissance Renal Research Institute, LLC
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
McLaren Northern Michigan Hospital-NISUS Research
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Providence Hospital, Research Dept.
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Clinical Research Consultants, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Sierra Nevada Nephrology Consultants
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
United Health Services
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Mount Sinai School of Medicine Lab
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Metrolina Nephrology Associates, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
ECU Department of Nephrology and Hypertension
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Sanford Research/USD-Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
University of Cincinnati Physicians Company
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Kaiser Permanente Northwest
City
Milwaukie
State/Province
Oregon
ZIP/Postal Code
97267
Country
United States
Facility Name
Northwest Renal Clinic, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Penn Medicine, Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Delaware Valley Nephrology and Hypertension Associates, PC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19118
Country
United States
Facility Name
Temple University School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
SC Nephrology & Hypertension Center, Inc.
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Erlanger Hospital Pharmacy
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Nephrology Associates, P.C.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Baylor College of Medicine ICTR
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fletcher Allen Health Care Renal Service
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Sentara Vascular Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Learn more about this trial

An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access

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