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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
9
Unnamed facility
Peoria, Illinois, United States
Unnamed facility
Shreveport, Louisiana, United States
Unnamed facility
Rochester, New York, United States
Unnamed facility
Cincinnati, Ohio, United States
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
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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
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