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Use of ABI-007 for the Prevention of Vascular Access Graft Failure in Patients Undergoing Hemodialysis
This study has been terminated.
Sponsored by: Abraxis BioScience Inc.
Information provided by: Abraxis BioScience Inc.
ClinicalTrials.gov Identifier: NCT00249002
  Purpose

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.


Condition Intervention Phase
Hemodialysis Graft Dysfunction
Drug: ABI-007
Phase II

MedlinePlus related topics: Dialysis Kidney Failure
Drug Information available for: Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Pilot Phase II Trial Of ABI-007 (A Cremophor El-Free, Protein Stabilized, Nanoparticle Paclitaxel) For The Prevention Of Vascular Access Graft Failure In Patients Undergoing Hemodialysis

Further study details as provided by Abraxis BioScience Inc.:

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;

Estimated Enrollment: 20
Study Start Date: November 2005
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Thrombosed graft within the past 7 days or a patent but dysfunctional 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:
  • ANC < 2.0 x 109/L;
  • platelets < 100 x 109/L;
  • Hgb < 9 g/dL.
  • Patient has the following blood chemistry levels at baseline:
  • AST (SGOT), ALT (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 HIV positive.
  • Patient is currently receiving other chemotherapy drug(s).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249002

Locations
United States, North Carolina
Abraxis Bioscience, Inc
Durham, North Carolina, United States, 27703
Sponsors and Collaborators
Abraxis BioScience Inc.
Investigators
Study Director: Angela Ogden, M.D. Abraxis BioScience Inc.
  More Information

Study ID Numbers: HD001
Study First Received: November 3, 2005
Last Updated: April 7, 2008
ClinicalTrials.gov Identifier: NCT00249002  
Health Authority: United States: Food and Drug Administration

Keywords provided by Abraxis BioScience Inc.:
Vascular Access Graft Failure
Venous Neointimal Hyperplasia(VNH)
Hemodialysis

Study placed in the following topic categories:
Hyperplasia
Paclitaxel

ClinicalTrials.gov processed this record on January 14, 2009