Use of ABI-007 for the Prevention of Vascular Access Graft Failure in Patients Undergoing Hemodialysis

This study has been terminated.

(Terminated due to pipeline prioritization)

Sponsor:

Information provided by (Responsible Party):

Celgene Corporation

ClinicalTrials.gov Identifier:

NCT00249002

First received: November 3, 2005

Last updated: August 7, 2012

Last verified: April 2012

History of Changes

Results First Received: February 21, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Hemodialysis Graft Dysfunction
Intervention:	Drug: ABI-007

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
ABI-007	ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21

Participant Flow: Overall Study

	ABI-007
STARTED	9
COMPLETED	2
NOT COMPLETED	7
Adverse Event	2
Study cancellation	3
Unspecified	2

Baseline Characteristics

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Reporting Groups

	Description
ABI-007	ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21

Baseline Measures

	ABI-007
Number of Participants [units: participants]	9
Age [units: years] Mean ± Standard Deviation	67.6 ± 8.16
Age, Customized [units: participants]
<65 years	4
>=65 years	5
Gender [units: participants]
Female	6
Male	3
Race/Ethnicity, Customized [units: participants]
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black of African heritage	7
White, Non-Hispanic and Non-Latino	2
White, Hispanic or Latino	0
Other	0
Weight [units: kg] Mean ± Standard Deviation	71.78 ± 13.271

Outcome Measures

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1. Primary:

Percentage of Participants With Discontinued, Delayed or Interrupted Therapy [ Time Frame: up to week 21 ]

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2. Primary:

Percentage of Participants Without Graft Failure or Need for Intervention [ Time Frame: 24 weeks ]

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3. Primary:

Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 12 [ Time Frame: 12 weeks ]

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4. Primary:

Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 24 [ Time Frame: 24 weeks ]

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5. Primary:

Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 9 [ Time Frame: 9 months ]

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6. Primary:

Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 12 [ Time Frame: 12 months ]

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7. Primary:

Stenosis (%) of a Non-index Lesion Using Angiography at Week 12 [ Time Frame: 12 weeks ]

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8. Primary:

Stenosis (%) of a Non-index Lesion Using Angiography at Week 24 [ Time Frame: 24 weeks ]

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9. Primary:

Stenosis (%) of a Non-index Lesion Using Angiography at Month 9 [ Time Frame: 9 months ]

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10. Primary:

Stenosis (%) of a Non-index Lesion Using Angiography at Month 12 [ Time Frame: 12 months ]

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11. Secondary:

Participants With Arthrosclerotic Cardiovascular Complications [ Time Frame: up to week 25 ]

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12. Secondary:

Kaplan Meier Estimates for Time to Graft Failure or Intervention [ Time Frame: up to 12 months ]

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13. Secondary:

Percentage of Participants With Patency of Index and Non-Index Lesions at 24 Weeks [ Time Frame: 24 weeks ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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: Study data will not be published in part before the complete multicenter data has been reported in full, unless more than 1 year has elapsed since completion of the Study. Investigator/institution must supply copy of presentation or publication to Celgene within 30 days of submission for publication. Celgene may request in writing within that 30 days that Celgene Confidential Information be deleted or be granted a 60 day delay prior to publication to permit intellectual property filings.

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
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Results Point of Contact:

Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00249002 History of Changes
Other Study ID Numbers:	HD001
Study First Received:	November 3, 2005
Results First Received:	February 21, 2012
Last Updated:	August 7, 2012
Health Authority:	United States: Food and Drug Administration

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