TerminatedNCT00249002Updated Nov 25, 2019Results posted

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

A Phase 2 interventional study of ABI-007 in Hemodialysis Graft Dysfunction, sponsored by Celgene. Terminated at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-25.

Sponsored by Celgene · Phase 2, Interventional, and Prevention

Why this study was terminated

Terminated due to pipeline prioritization

Phase: Phase 2
Study type: Interventional
Enrollment: 9
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

This study is designed to confirm the safety of the proposed dose and schedule of ABI-007 for hemodialysis patients with vascular access device failure, and to obtain preliminary data on the effectiveness of such treatment.

Read the detailed description

This is an open-label, pilot, phase II study to assess the feasibility of administering ABI-007 intravenously [IV] over 3-5 minutes to patients with hemodialysis graft dysfunction (i.e., either a thrombosed polytetrafluoroethylene (PTFE) graft, or a patent but dysfunctional PTFE graft). Patients with graft dysfunction who are successfully treated with angioplasty will start treatment after angioplasty or during their first dialysis through the graft following intervention, and will receive 3 subsequent treatments of ABI-007 at 35 mg/m\^2 on weeks 5, 13 and 21.

Conditions studied

Hemodialysis Graft Dysfunction

Keywords

Vascular Access Graft Failure
Venous Neointimal Hyperplasia(VNH)
Hemodialysis

In context

Lead sponsor

Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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).

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 9 participants (actual)

Study arms

Experimental
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
Drug: ABI-007

Interventions

DrugABI-007
Also known as: Abraxane®, paclitaxel

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 9 months
Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 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.
Time frame: 12 months
Stenosis (%) of a Non-index Lesion Using Angiography at Week 12
Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.
Time frame: 12 weeks
Stenosis (%) of a Non-index Lesion Using Angiography at Week 24
Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.
Time frame: 24 weeks
Stenosis (%) of a Non-index Lesion Using Angiography at Month 9
Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.
Time frame: 9 months
Stenosis (%) of a Non-index Lesion Using Angiography at Month 12
Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.
Time frame: 12 months

Secondary outcomes

Participants With Arthrosclerotic Cardiovascular Complications
Counts of participants who had treatment-emergent arthrosclerotic cardiovascular complications, specifically myocardial infarction, arterial thromboses, or cerebrovascular events.
Time frame: up to week 25
Kaplan Meier Estimates for Time to Graft Failure or Intervention
The time to graft failure or intervention was defined as the time from first dose of study drug to the first time graft failure or intervention. Participants who did not have graft failure or intervention at the end of the study were censored at the last known time that the participant had angiography.
Time frame: up to 12 months
Percentage of Participants With Patency of Index and Non-Index Lesions at 24 Weeks
The patency (unblocking) for index lesions is defined as \<50% of stenosis and no PFTE graft thrombosis at 24 weeks. The patency for non-index lesions is defined as \<50% of stenosis and no new non-index lesions at 24 weeks.
Time frame: 24 weeks

Results

Posted Mar 13, 2012

Participant flow

Participant flow — Overall Study
Milestone	ABI-007
Started	9
Completed	2
Not completed	7
Withdrew: Adverse event	2
Withdrew: Study cancellation	3
Withdrew: Other	2

Outcome measures

PrimaryPercentage 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.

Time frame:: up to week 21
Reported as:: Number · percentage of participants

Percentage of Participants With Discontinued, Delayed or Interrupted Therapy
percentage of participants	ABI-007
Delayed dose	44
Interrupted	0
Discontinued therapy	33

PrimaryPercentage 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.

Time frame:: 24 weeks
Reported as:: Number · percentage of participants

Percentage of Participants Without Graft Failure or Need for Intervention
percentage of participants	ABI-007
Percentage of Participants Without Graft Failure or Need for Intervention	0

PrimaryStenosis (%) 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.

Time frame:: 12 weeks
Reported as:: Mean · percentage of stenosis

Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 12
percentage of stenosis	ABI-007
Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 12	61.7 ± 32.51

PrimaryStenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 24

Time frame:: 24 weeks
Reported as:: Mean · percentage of stenosis

Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 24
percentage of stenosis	ABI-007
Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 24	79.0 ± 11.40

SecondaryParticipants With Arthrosclerotic Cardiovascular Complications

Counts of participants who had treatment-emergent arthrosclerotic cardiovascular complications, specifically myocardial infarction, arterial thromboses, or cerebrovascular events.

Time frame:: up to week 25
Reported as:: Number · participants

Participants With Arthrosclerotic Cardiovascular Complications
participants	ABI-007
>=1 arthrosclerotic cardiovascular complication	4
Bradycardia	1
Hypotension	1
Hypertrophic obstructive cardiomyopathy	1
Carotid artery stenosis	1
Cerebrovascular accident	1
Cardiovascular disorder	1

SecondaryKaplan Meier Estimates for Time to Graft Failure or Intervention

The time to graft failure or intervention was defined as the time from first dose of study drug to the first time graft failure or intervention. Participants who did not have graft failure or intervention at the end of the study were censored at the last known time that the participant had angiography.

Time frame:: up to 12 months
Reported as:: Median · weeks

Kaplan Meier Estimates for Time to Graft Failure or Intervention
weeks	ABI-007
Kaplan Meier Estimates for Time to Graft Failure or Intervention	11.4 (11.0 to 12.0)

SecondaryPercentage of Participants With Patency of Index and Non-Index Lesions at 24 Weeks

The patency (unblocking) for index lesions is defined as \<50% of stenosis and no PFTE graft thrombosis at 24 weeks. The patency for non-index lesions is defined as \<50% of stenosis and no new non-index lesions at 24 weeks.

Time frame:: 24 weeks
Reported as:: Number · percentage of participants

Percentage of Participants With Patency of Index and Non-Index Lesions at 24 Weeks
percentage of participants	ABI-007
Index lesion	14
Non-Index lesions	57

PrimaryStenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 9

Time frame:: 9 months
Reported as:: Mean · percentage of stenosis

Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 9
percentage of stenosis	ABI-007
Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 9	69.3 ± 4.04

PrimaryStenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 12

Time frame:: 12 months
Reported as:: Number · percentage of stenosis

Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 12
percentage of stenosis	ABI-007
Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 12	95.0

PrimaryStenosis (%) of a Non-index Lesion Using Angiography at Week 12

Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.

Time frame:: 12 weeks
Reported as:: Mean · percentage of stenosis

Stenosis (%) of a Non-index Lesion Using Angiography at Week 12
percentage of stenosis	ABI-007
Central vein	50.0 ± NA
Intragraft	35.0 ± 35.36
Arterial anastomosis	25.0 ± NA

PrimaryStenosis (%) of a Non-index Lesion Using Angiography at Week 24

Time frame:: 24 weeks
Reported as:: Mean · percentage of stenosis

Stenosis (%) of a Non-index Lesion Using Angiography at Week 24
percentage of stenosis	ABI-007
Central vein	40.0 ± NA
Intragraft	45.0 ± 21.21
Arterial anastomosis	27.5 ± NA

PrimaryStenosis (%) of a Non-index Lesion Using Angiography at Month 9

Time frame:: 9 months
Reported as:: Mean · percentage of stenosis

Stenosis (%) of a Non-index Lesion Using Angiography at Month 9
percentage of stenosis	ABI-007
Central vein	65.0 ± NA
Intragraft	57.5 ± 10.61
Arterial anastomosis	25.0 ± NA

PrimaryStenosis (%) of a Non-index Lesion Using Angiography at Month 12

Time frame:: 12 months
Reported as:: Number · percentage of stenosis

Stenosis (%) of a Non-index Lesion Using Angiography at Month 12
percentage of stenosis	ABI-007
Central vein	NA ± NA
Intragraft	50.0
Arterial anastomosis	25.0

Adverse events

Collected over AEs collected up to 30 days after the last ABI-007 dose administration (Week 21), except for cardiovascular side effects or other events at the investigator's discretion, which would be reported whenever they occur.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
ABI-007	—	6/9 (66.7%)	7/9 (77.8%)

Most frequent serious events

Most frequent serious events
Event	ABI-007
Anastomotic stenosisInjury, poisoning and procedural complications	2/9
Contrast media reactionInjury, poisoning and procedural complications	1/9
Graft thrombosisInjury, poisoning and procedural complications	1/9
Gastrointestinal haemorrhageGastrointestinal disorders	1/9
Cerebrovascular accidentNervous system disorders	1/9

Most frequent other events

Showing 10 of 31

Most frequent other events
Event	ABI-007
Anastomotic stenosisInjury, poisoning and procedural complications	3/9
Vascular graft complicationInjury, poisoning and procedural complications	2/9
Neuropathy peripheralNervous system disorders	2/9
DiarrhoeaGastrointestinal disorders	2/9
CoughRespiratory, thoracic and mediastinal disorders	2/9
Contrast media reactionInjury, poisoning and procedural complications	1/9
Procedural painInjury, poisoning and procedural complications	1/9
BradycardiaCardiac disorders	1/9
Cardiovascular disorderCardiac disorders	1/9
Hypertrophic obstructive cardiomyopathyCardiac disorders	1/9

Baseline characteristics

Age, Continuous
Age, Continuous(years)	ABI-007
Mean	67.6 ± 8.16

Age, Customized
Age, Customized(participants)	ABI-007
<65 years	4
>=65 years	5

Sex: Female, Male
Sex: Female, Male(Participants)	ABI-007
Female	6
Male	3

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	ABI-007
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
Weight(kg)	ABI-007
Mean	71.78 ± 13.271

Study locations

4 sites

Peoria, Illinois, United States
Shreveport, Louisiana, United States
Rochester, New York, United States
Cincinnati, Ohio, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00249002
Lead sponsor: Celgene
Responsible party: Sponsor
First posted: Nov 7, 2005
Start date: Nov 1, 2005
Primary completion: Nov 1, 2007
Completion: Nov 1, 2007
Results posted: Mar 13, 2012
Last update: Nov 25, 2019

Study contacts

Jose Iglesias, MD

study director · Celgene Corporation

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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