NCT00249002

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemodialysis Graft Dysfunction

Interventions

Type	Name	Description
DRUG	ABI-007

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2005-11-07
• Last updated: 2019-11-25
• Results posted: 2012-03-13

Locations

4 sites across 1 country: United States