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

History of Changes

Results First Received: October 16, 2015

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single Blind (Participant); Primary Purpose: Treatment
Condition:	Arteriovenous Fistula
Interventions:	Biological: SRM003 Other: Participating Site's standard practice

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Hide Baseline Characteristics

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
Overall Participants Analyzed [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

Show All Outcome Measures

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 ]

Show Outcome Measure 1

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 ]

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

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 ]

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

Limitations and Caveats

Hide Limitations and Caveats

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
No text entered.

More Information

Hide More Information

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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually

Results Point of Contact:

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

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

To Top