Primary Outcome Measures:
- Primary Safety/Tolerability Endpoints: the percentage of patients delaying or discontinuing therapy for an adverse event and the incidence of treatment-emergent adverse events (AEs) and serious
- Primary Efficacy Endpoints:
- ♦ Percentage of patients without graft failure or need for intervention at 24 weeks.
- ♦ Stenosis (%) of the index lesion and non-index lesions using angiography at 12 and 24 weeks and at 9 and 12 months.
Secondary Outcome Measures:
- Secondary Efficacy Endpoints:
- ♦ Incidence of atherosclerotic cardiovascular complications (e.g. myocardial
- infarction, arterial thromboses, or cerebrovascular events);
- ♦ Time to graft failure or intervention;
- ♦ Patency of the index lesion at 24 weeks;
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 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/m2 on weeks 5, 13 and 21.