Hemodialysis Graft DysfunctionPhase 2NCT00249002
Use of ABI-007 for the Prevention of Vascular Access Graft Failure in Patients Undergoing Hemodialysis
A Phase 2 study testing ABI-007 in people with Hemodialysis Graft Dysfunction, run by Celgene at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Graft Dysfunction
- What is being tested?
- ABI-007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Nov 2005to 1 Nov 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 22Show fewer
- 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).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Cincinnati, Ohio
Study site
Peoria, Illinois
Study site
Rochester, New York
Study site
Shreveport, Louisiana
About this 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
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.
Read the 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
- Being tested
- ABI-007
- Keywords
- Vascular Access Graft Failure, Venous Neointimal Hyperplasia(VNH), Hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-007Drug
Also called Abraxane®, paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: ABI-007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (3)
Participants With Arthrosclerotic Cardiovascular Complications
Counts of participants who had treatment-emergent arthrosclerotic cardiovascular complications, specifically myocardial infarction, arterial thromboses, or cerebrovascular events.
Measured: up to week 25
Kaplan Meier Estimates for Time to Graft Failure or Intervention
The time to graft failure or intervention was defined as the time from first dose of study drug to the first time graft failure or intervention. Participants who did not have graft failure or intervention at the end of the study were censored at the last known time that the participant had angiography.
Measured: up to 12 months
Percentage of Participants With Patency of Index and Non-Index Lesions at 24 Weeks
The patency (unblocking) for index lesions is defined as <50% of stenosis and no PFTE graft thrombosis at 24 weeks. The patency for non-index lesions is defined as <50% of stenosis and no new non-index lesions at 24 weeks.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study start1 Nov 2005
- Primary completion1 Nov 2007
- Study completion1 Nov 2007
Why it stopped: Terminated due to pipeline prioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemodialysis Graft DysfunctionStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Iglesias, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249002
- Sponsor's protocol ID
- HD001
- Status last verified
- Nov 2019
- First submitted
- 3 Nov 2005
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00249002
- Acronym / sponsor ID
- HD001
- Conditions
- Hemodialysis Graft Dysfunction
- Keywords
- Vascular Access Graft Failure, Venous Neointimal Hyperplasia(VNH), Hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to pipeline prioritization
- Enrolment
- 9 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2005 (actual)
- Primary completion
- 1 Nov 2007 (actual)
- Study completion
- 1 Nov 2007 (actual)
- First posted
- 7 Nov 2005 (estimated)
- Results
- Posted 13 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABI-007 | Experimental | Drug: ABI-007ABI-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABI-007Also: Abraxane®, paclitaxel | Drug | ABI-007 |
Primary outcome
Percentage of Participants With Discontinued, Delayed or Interrupted Therapy
Time frame: up to week 21
Percentage of participants who had discontinued therapy or had a delayed dose or an interrupted (omitted) dose due to toxicities/adverse events.
Percentage of Participants Without Graft Failure or Need for Intervention
Time frame: 24 weeks
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.
Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 12
Time frame: 12 weeks
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.
Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 24
Time frame: 24 weeks
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.
Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 9
Time frame: 9 months
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.
Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 12
Time frame: 12 months
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.
Stenosis (%) of a Non-index Lesion Using Angiography at Week 12
Time frame: 12 weeks
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.
Stenosis (%) of a Non-index Lesion Using Angiography at Week 24
Time frame: 24 weeks
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.
Stenosis (%) of a Non-index Lesion Using Angiography at Month 9
Time frame: 9 months
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.
Stenosis (%) of a Non-index Lesion Using Angiography at Month 12
Time frame: 12 months
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.
3 secondary outcomes
Participants With Arthrosclerotic Cardiovascular Complications
Time frame: up to week 25
Kaplan Meier Estimates for Time to Graft Failure or Intervention
Time frame: up to 12 months
Percentage of Participants With Patency of Index and Non-Index Lesions at 24 Weeks
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hemodialysis Graft Dysfunction
Active, not recruiting
Drug-Eluting Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis (DEBAVAS)
Dysfunction of Hemodialysis Vascular Access (Fistula and Graft)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Iglesias, MD study director
Celgene Corporation
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABI-007 in people with Hemodialysis Graft Dysfunction, run by Celgene at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Discontinued, Delayed or Interrupted Therapy (time frame: up to week 21). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.