Conditions: Hemodialysis Graft Dysfunction
Keywords: Vascular Access Graft Failure Venous Neointimal Hyperplasia(VNH) Hemodialysis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 9
Healthy volunteers: no

Brief 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.

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.

Arms:
arm 1: 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

Interventions: intervention 1: ABI-007
Intervention descriptions: intervention 1: None

Protocol document: