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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01806545
First received: March 5, 2013
Last updated: November 20, 2015
Last verified: November 2015
Results First Received: October 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Arteriovenous Fistula
Interventions: Biological: SRM003
Other: Participating Site's standard practice

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Participating Site's Standard Practice Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
SRM003 Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.

Participant Flow:   Overall Study
    Participating Site's Standard Practice     SRM003  
STARTED     29     35  
COMPLETED     23     30  
NOT COMPLETED     6     5  
Adverse Event                 2                 3  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 3                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent -to-Treat (ITT) population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.

Reporting Groups
  Description
Participating Site's Standard Practice Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
SRM003 Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Total Total of all reporting groups

Baseline Measures
    Participating Site's Standard Practice     SRM003     Total  
Number of Participants  
[units: participants]
  29     35     64  
Age  
[units: years]
Mean (Standard Deviation)
  65.2  (13.5)     61.1  (10.8)     63.0  (12.2)  
Age, Customized  
[units: participants]
     
<65 years     12     23     35  
≥65 years     17     12     29  
Gender  
[units: participants]
     
Female     11     13     24  
Male     18     22     40  



  Outcome Measures
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1.  Primary:   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   [ Time Frame: 12 weeks after surgery ]

2.  Secondary:   Percentage of Participants With AVF Maturation by Week 26 Visit Based on Hemodialysis or CDUS And Vascular Access Examination   [ Time Frame: 26 weeks after surgery ]

3.  Secondary:   Time to AVF Maturation Based on Hemodialysis or CDUS and Vascular Access Examination   [ Time Frame: Up to 26 weeks after surgery ]

4.  Secondary:   Percentage of Participants With Loss of Unassisted Primary Patency   [ Time Frame: Up to 26 weeks after surgery ]

5.  Secondary:   Percentage of Participants With Loss of Assisted Primary Patency   [ Time Frame: Up to 26 weeks after surgery ]

6.  Secondary:   Percentage of Participants With Loss of Secondary Patency   [ Time Frame: Up to 26 weeks after surgery ]

7.  Secondary:   Change From Week 1 in Average Vascular Access Lumen Diameter Using CDUS   [ Time Frame: 1, 12, and 26 weeks after surgery ]

8.  Secondary:   Percentage of Participants With Clinical Success Based on First Use of The Study AVF For Hemodialysis   [ Time Frame: 12 and 26 weeks after surgery ]

9.  Secondary:   Number of Interventions to Establish, Maintain, or Restore Patency   [ Time Frame: 12 and 26 weeks after surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Physician
Organization: Shire Development LLC
phone: +1 866 842 5335


No publications provided


Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01806545     History of Changes
Other Study ID Numbers: AVF01-SRM003
Study First Received: March 5, 2013
Results First Received: October 16, 2015
Last Updated: November 20, 2015
Health Authority: United States: Food and Drug Administration