An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access - Study Results

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

Participant Flow

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 78 weeks of follow-up for assessment of efficacy and safety.
SRM003	Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. After surgery, subjects were to undergo assessments during the 78-week follow-up period.

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 78 weeks of follow-up for assessment of efficacy and safety.

SRM003

Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.

After surgery, subjects were to undergo assessments during the 78-week follow-up period.

Participant Flow: Overall Study

	Participating Site's Standard Practice	SRM003
STARTED	14	18
COMPLETED	0	0
NOT COMPLETED	14	18
Adverse Event	2	1
Death	1	0
Lost to Follow-up	0	2
Study terminated by sponsor	9	14
Withdrawal by Subject	1	1
Other unspecified	1	0

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 population, defined as all randomly assigned participants regardless of the treatment received 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 78 weeks of follow-up for assessment of efficacy and safety.
SRM003	Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. After surgery, subjects were to undergo assessments during the 78-week follow-up period.
Total	Total of all 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 78 weeks of follow-up for assessment of efficacy and safety.

SRM003

Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.

After surgery, subjects were to undergo assessments during the 78-week follow-up period.

Total

Total of all reporting groups

Baseline Measures

	Participating Site's Standard Practice	SRM003	Total
Overall Participants Analyzed [Units: Participants]	14	18	32

Age [Units: Years] Mean (Standard Deviation)	62.8 (10.0)	60.9 (7.9)	61.7 (8.8)

Age, Customized [Units: Participants]
<65 years	9	12	21
≥65 years	5	6	11

Gender [Units: Participants]
Female	8	10	18
Male	6	8	14

Outcome Measures

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1. Primary:

Percentage of Participants With Loss of Unassisted Primary Patency [ Time Frame: Up to 78 weeks after surgery ]

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2. Secondary:

Percentage of Participants With Loss of Assisted Primary Patency [ Time Frame: Up to 78 weeks after surgery ]

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3. Secondary:

Percentage of Participants With Loss of Secondary Patency [ Time Frame: Up to 78 weeks after surgery ]

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4. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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
Study was discontinued early due to Sponsor decision.

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:

	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:	NCT01806584 History of Changes
Other Study ID Numbers:	AVG01-SRM003
Study First Received:	March 5, 2013
Results First Received:	October 16, 2015
Last Updated:	November 25, 2015