Trial Outcomes & Findings for Use of ABI-007 for the Prevention of Vascular Access Graft Failure in Patients Undergoing Hemodialysis (NCT NCT00249002)

Last Updated: 2019-11-25

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

up to week 21

Results posted on

2019-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	9
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Adverse Event	2
Overall Study Study cancellation	3
Overall Study Other	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABI-007 n=9 Participants 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
Age, Continuous	67.6 years STANDARD_DEVIATION 8.16 • n=99 Participants
Age, Customized <65 years	4 participants n=99 Participants
Age, Customized >=65 years	5 participants n=99 Participants
Sex: Female, Male Female	6 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=99 Participants
Race/Ethnicity, Customized Asian	0 participants n=99 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=99 Participants
Race/Ethnicity, Customized Black of African heritage	7 participants n=99 Participants
Race/Ethnicity, Customized White, Non-Hispanic and Non-Latino	2 participants n=99 Participants
Race/Ethnicity, Customized White, Hispanic or Latino	0 participants n=99 Participants
Race/Ethnicity, Customized Other	0 participants n=99 Participants
Weight	71.78 kg STANDARD_DEVIATION 13.271 • n=99 Participants

PRIMARY outcome

Timeframe: up to week 21

Population: Treated population

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

Outcome measures

Outcome measures
Measure	ABI-007 n=9 Participants 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
Percentage of Participants With Discontinued, Delayed or Interrupted Therapy Delayed dose	44 percentage of participants
Percentage of Participants With Discontinued, Delayed or Interrupted Therapy Interrupted	0 percentage of participants
Percentage of Participants With Discontinued, Delayed or Interrupted Therapy Discontinued therapy	33 percentage of participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Evaluable participants who were treated

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.

Outcome measures

Outcome measures
Measure	ABI-007 n=7 Participants 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
Percentage of Participants Without Graft Failure or Need for Intervention	0 percentage of participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Treated population of participants with an index lesion at this site.

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.

Outcome measures

Outcome measures
Measure	ABI-007 n=6 Participants 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
Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 12	61.7 percentage of stenosis Standard Deviation 32.51

PRIMARY outcome

Timeframe: 24 weeks

Population: Treated population of participants with an index lesion at this site.

Outcome measures

Outcome measures
Measure	ABI-007 n=5 Participants 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
Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 24	79.0 percentage of stenosis Standard Deviation 11.40

PRIMARY outcome

Timeframe: 9 months

Population: Treated population of participants with an index lesion at this site.

Outcome measures

Outcome measures
Measure	ABI-007 n=3 Participants 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
Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 9	69.3 percentage of stenosis Standard Deviation 4.04

PRIMARY outcome

Timeframe: 12 months

Population: Treated population of participants with an index lesion at this site.

Outcome measures

Outcome measures
Measure	ABI-007 n=1 Participants 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
Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 12	95.0 percentage of stenosis

PRIMARY outcome

Timeframe: 12 weeks

Population: Treated population of participants with a non-index lesion.

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.

Outcome measures

Outcome measures
Measure	ABI-007 n=2 Participants 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
Stenosis (%) of a Non-index Lesion Using Angiography at Week 12 Central vein	50.0 percentage of stenosis Standard Deviation NA only one participant
Stenosis (%) of a Non-index Lesion Using Angiography at Week 12 Intragraft	35.0 percentage of stenosis Standard Deviation 35.36
Stenosis (%) of a Non-index Lesion Using Angiography at Week 12 Arterial anastomosis	25.0 percentage of stenosis Standard Deviation NA only one participant

PRIMARY outcome

Timeframe: 24 weeks

Population: Treated population of participants with a non-index lesion.

Outcome measures

Outcome measures
Measure	ABI-007 n=2 Participants 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
Stenosis (%) of a Non-index Lesion Using Angiography at Week 24 Central vein	40.0 percentage of stenosis Standard Deviation NA only one participant
Stenosis (%) of a Non-index Lesion Using Angiography at Week 24 Intragraft	45.0 percentage of stenosis Standard Deviation 21.21
Stenosis (%) of a Non-index Lesion Using Angiography at Week 24 Arterial anastomosis	27.5 percentage of stenosis Standard Deviation NA only one participant

PRIMARY outcome

Timeframe: 9 months

Population: Treated population of participants with a non-index lesion.

Outcome measures

Outcome measures
Measure	ABI-007 n=2 Participants 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
Stenosis (%) of a Non-index Lesion Using Angiography at Month 9 Central vein	65.0 percentage of stenosis Standard Deviation NA only one participant
Stenosis (%) of a Non-index Lesion Using Angiography at Month 9 Intragraft	57.5 percentage of stenosis Standard Deviation 10.61
Stenosis (%) of a Non-index Lesion Using Angiography at Month 9 Arterial anastomosis	25.0 percentage of stenosis Standard Deviation NA only one participant

PRIMARY outcome

Timeframe: 12 months

Population: Treated population of participants with a non-index lesion.

Outcome measures

Outcome measures
Measure	ABI-007 n=1 Participants 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
Stenosis (%) of a Non-index Lesion Using Angiography at Month 12 Central vein	NA percentage of stenosis NA no participants at this timepoint
Stenosis (%) of a Non-index Lesion Using Angiography at Month 12 Intragraft	50.0 percentage of stenosis
Stenosis (%) of a Non-index Lesion Using Angiography at Month 12 Arterial anastomosis	25.0 percentage of stenosis

SECONDARY outcome

Timeframe: up to week 25

Population: Treated population

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

Outcome measures

Outcome measures
Measure	ABI-007 n=9 Participants 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
Participants With Arthrosclerotic Cardiovascular Complications Cardiovascular disorder	1 participants
Participants With Arthrosclerotic Cardiovascular Complications >=1 arthrosclerotic cardiovascular complication	4 participants
Participants With Arthrosclerotic Cardiovascular Complications Bradycardia	1 participants
Participants With Arthrosclerotic Cardiovascular Complications Hypotension	1 participants
Participants With Arthrosclerotic Cardiovascular Complications Hypertrophic obstructive cardiomyopathy	1 participants
Participants With Arthrosclerotic Cardiovascular Complications Carotid artery stenosis	1 participants
Participants With Arthrosclerotic Cardiovascular Complications Cerebrovascular accident	1 participants

SECONDARY outcome

Timeframe: up to 12 months

Population: Treated population

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.

Outcome measures

Outcome measures
Measure	ABI-007 n=8 Participants 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
Kaplan Meier Estimates for Time to Graft Failure or Intervention	11.4 weeks Interval 11.0 to 12.0

SECONDARY outcome

Timeframe: 24 weeks

Population: Treated Population of evaluable participants

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.

Outcome measures

Outcome measures
Measure	ABI-007 n=7 Participants 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
Percentage of Participants With Patency of Index and Non-Index Lesions at 24 Weeks Index lesion	14 percentage of participants
Percentage of Participants With Patency of Index and Non-Index Lesions at 24 Weeks Non-Index lesions	57 percentage of participants

Adverse Events

ABI-007

Serious events: 6 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ABI-007 n=9 participants at risk 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
Injury, poisoning and procedural complications Anastomotic stenosis	22.2% 2/9 • Number of events 2 • 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.
Injury, poisoning and procedural complications Contrast media reaction	11.1% 1/9 • Number of events 1 • 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.
Injury, poisoning and procedural complications Graft thrombosis	11.1% 1/9 • Number of events 1 • 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.
Gastrointestinal disorders Gastrointestinal haemorrhage	11.1% 1/9 • Number of events 1 • 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.
Nervous system disorders Cerebrovascular accident	11.1% 1/9 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	ABI-007 n=9 participants at risk 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
Injury, poisoning and procedural complications Anastomotic stenosis	33.3% 3/9 • Number of events 4 • 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.
Injury, poisoning and procedural complications Vascular graft complication	22.2% 2/9 • Number of events 4 • 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.
Injury, poisoning and procedural complications Contrast media reaction	11.1% 1/9 • Number of events 1 • 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.
Injury, poisoning and procedural complications Procedural pain	11.1% 1/9 • Number of events 1 • 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.
Cardiac disorders Bradycardia	11.1% 1/9 • Number of events 1 • 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.
Cardiac disorders Cardiovascular disorder	11.1% 1/9 • Number of events 2 • 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.
Cardiac disorders Hypertrophic obstructive cardiomyopathy	11.1% 1/9 • Number of events 1 • 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.
Nervous system disorders Neuropathy peripheral	22.2% 2/9 • Number of events 2 • 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.
Nervous system disorders Carotid artery stenosis	11.1% 1/9 • Number of events 1 • 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.
Nervous system disorders Facial palsy	11.1% 1/9 • Number of events 1 • 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.
Gastrointestinal disorders Diarrhoea	22.2% 2/9 • Number of events 3 • 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.
Gastrointestinal disorders Duodenitis	11.1% 1/9 • Number of events 1 • 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.
Gastrointestinal disorders Haemorrhoids	11.1% 1/9 • Number of events 1 • 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.
Gastrointestinal disorders Nausea	11.1% 1/9 • Number of events 1 • 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.
Gastrointestinal disorders Oesophageal ulcer	11.1% 1/9 • Number of events 1 • 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.
Infections and infestations Diverticulitis	11.1% 1/9 • Number of events 1 • 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.
Infections and infestations Nasopharyngitis	11.1% 1/9 • Number of events 1 • 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.
Infections and infestations Pneumonia	11.1% 1/9 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Cough	22.2% 2/9 • Number of events 2 • 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.
Skin and subcutaneous tissue disorders Alopecia	11.1% 1/9 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Pruritis	11.1% 1/9 • Number of events 1 • 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.
Vascular disorders Hypotension	11.1% 1/9 • Number of events 1 • 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.
Vascular disorders Venous stenosis	11.1% 1/9 • Number of events 2 • 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.
Blood and lymphatic system disorders Anaemia	11.1% 1/9 • Number of events 1 • 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.
Blood and lymphatic system disorders Thrombocytopenia	11.1% 1/9 • Number of events 1 • 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.
General disorders Asthenia	11.1% 1/9 • Number of events 1 • 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.
Investigations Weight decreased	11.1% 1/9 • Number of events 1 • 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.
Metabolism and nutrition disorders Vitamin D deficiency	11.1% 1/9 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Myalgia	11.1% 1/9 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	11.1% 1/9 • Number of events 1 • 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.
Psychiatric disorders Anxiety	11.1% 1/9 • Number of events 1 • 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.

Additional Information

Associate Director, Clinical Trials Disclosure

Celgene Corporation

Phone: 1-888-260-1599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee * 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.
Publication restrictions are in place

Restriction type: OTHER