Use of ABI-007 for the Prevention of Vascular Access Graft Failure in Patients Undergoing Hemodialysis

NCT00249002 | Terminated Phase 2 Results

• 1 other identifier: HD001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

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.

Conditions

Hemodialysis Graft Dysfunction

Keywords

Vascular Access Graft Failure; Venous Neointimal Hyperplasia(VNH); Hemodialysis

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  9 months

• Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 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.

  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.

  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.

  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.

  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.

  12 months

Secondary Outcomes (3)

• Participants With Arthrosclerotic Cardiovascular Complications

  up to week 25

• Kaplan Meier Estimates for Time to Graft Failure or Intervention

  up to 12 months

• Percentage of Participants With Patency of Index and Non-Index Lesions at 24 Weeks

  24 weeks

Study Arms (1)

ABI-007

EXPERIMENTAL

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

Drug: ABI-007

Interventions

ABI-007 DRUG

Also known as: Abraxane®, paclitaxel

ABI-007

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (4)

Unknown Facility

Peoria, Illinois, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

MeSH Terms

Interventions

Albumin-Bound Paclitaxel; Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Associate Director, Clinical Trials Disclosure
• Organization: Celgene Corporation

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Study Officials

• Jose Iglesias, MD

  Celgene Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 7, 2005
• Study Start: November 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: November 25, 2019
• Results First Posted: March 13, 2012

Record last verified: 2019-11

Locations

US (4)