Use of ABI-007 for the Prevention of Vascular Access Graft Failure in Patients Undergoing Hemodialysis
Condition: Hemodialysis Graft Dysfunction
Intervention: ABI-007
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vascular Access Graft Failure; Venous Neointimal Hyperplasia(VNH); Hemodialysis

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.
    

Eligibility criteria:

        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:

          -  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).