Use of ABI-007 for the Prevention of Vascular Access Graf... | NCT00249002

NCT00249002

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Label	Type	Description	Intervention Names
ABI-007	Experimental	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	Drug: ABI-007

Name	Type	Description	Arm Group Labels	Other Names
ABI-007	Drug		ABI-007	Abraxane® paclitaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Discontinued, Delayed or Interrupted Therapy	Percentage of participants who had discontinued therapy or had a delayed dose or an interrupted (omitted) dose due to toxicities/adverse events.	up to week 21
Percentage of Participants Without Graft Failure or Need for Intervention	Graft failure is defined as graft thrombosis, loss of vascular access function, or >50% stenosis of the index lesion at the time of a regularly scheduled angiographic assessment.	24 weeks
Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 12	Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.	12 weeks
Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 24	Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.	24 weeks
Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 9	Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.	9 months

Secondary Outcomes

Measure	Description	Time Frame
Participants With Arthrosclerotic Cardiovascular Complications	Counts of participants who had treatment-emergent arthrosclerotic cardiovascular complications, specifically myocardial infarction, arterial thromboses, or cerebrovascular events.	up to week 25
Kaplan Meier Estimates for Time to Graft Failure or Intervention

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Thrombosed graft within the past 7 days or a patent but dysfunctional polytetrafluoroethylene (PTFE) graft (identified by any means) with a stenosis of greater than 50% at the graft-vein anastomosis or within 8 centimeters of the graft-vein anastomosis which will be referred to as the index lesion. Following angioplasty patients must have residual stenosis of less than 20% post angioplasty for the index lesion and for all other stenoses; also index lesion must be located in the arm. PTFE graft requiring angioplasty must be at least 30 days old.
Male or non-pregnant and non-lactating female, and ≥ 18 years of age.
Patient or guardian has provided a signed written informed consent for the administration of ABI-007 (post-angioplasty or at the time of first dialysis through the new graft) using a form that is approved by the local IRB/ethics committee of the investigative site.
Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.

Exclusion Criteria:

Use of a stent at the time of current angioplasty or at any previous time in the index lesion.
No perforation at the time of current angioplasty.
Thrombosed graft for more than 7 days.
Patient has the following blood counts at baseline:
Absolute neutrophil count (ANC) < 2.0*10^9/L;
platelets < 100*10^9/L;
Hemoglobin (Hgb) < 9 g/dL.
Patient has the following blood chemistry levels at baseline:
Aspartate transaminase (AST or SGOT), alanine transaminase (ALT or SGPT) > 2.5x upper limit of normal range (ULN);
total bilirubin ≥ upper limit of normal (ULN);
Unable to give informed consent, or for whom informed consent cannot be obtained from a legal guardian.
Women who are pregnant and women of child bearing potential who do not use adequate contraception.
2 procedures of percutaneous or surgical intervention on the PTFE graft within the previous 90 days.
Previous participation in another study with any investigational drug or device within the past 30 days or current enrollment in any other clinical protocol or investigational trial.
Patient has a life expectancy of less than 6 months.
Intended kidney transplant within 6 months of enrollment in the study
Any significant medical condition which in the investigators opinion may interfere with the patients optimal participation in the study.
Patient is, in the investigator's opinion, unlikely to be able to complete the study through the End of Study (EOS) visit.
Patient has a history of allergy or hypersensitivity to the study drug.
Documented hypercoagulable state requiring anti-coagulation (protein S, protein C, antiphospholipid; anticoagulation on an empiric basis for graft thromboses in not a contradiction).
Patient is human immunodeficiency virus (HIV) positive.
Patient is currently receiving other chemotherapy drug(s).

Name	Affiliation	Role
Jose Iglesias, MD	Celgene Corporation	Study Director

ID	Title	Description
FG000	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 Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Discontinued, Delayed or Interrupted Therapy

Percentage of participants who had discontinued therapy or had a delayed dose or an interrupted (omitted) dose due to toxicities/adverse events.

Treated population

Posted

Number

percentage of participants

up to week 21

ID	Title	Description
OG000	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

Units	Counts
Participants

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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

Facility	Status	City	State	ZIP	Country	Contacts
		Peoria	Illinois		United States

ID	Term
D000068196	Albumin-Bound Paclitaxel
D017239	Paclitaxel

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic