Kidney FailurePhase 3FISTULANCT03289520
Clopidogrel Prevention of Early Arteriovenous (AV) Fistula Thrombosis
A Phase 3 study testing Clopidogrel in people with Kidney Failure and Hemodialysis Fistula Thrombosis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 9 sites in United States.
Trial summary
The objective of the study is to determine whether clopidogrel reduces the early failure rate of native AV fistulae. This study was originally registered as NCT00067119 which included two protocols, this one and the GRAFT study) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Hemodialysis Fistula Thrombosis
- What is being tested?
- Clopidogrel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 877 participants
- Where
- 9 sitesUnited States
- Study dates
- 7 Jan 2003to 18 Jun 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Age 18-21 depending on state regulations
- Life expectancy of at least six months
- Chronic renal failure with anticipated start of hemodialysis within six months of enrollment, or current dialysis dependence
- Planned creation of native upper extremity AV fistula
- The patient is not on aspirin, or the patient is on aspirin but has not had a myocardial infarction or a cerebrovascular accident within the past 12 months.
- The patient is expected to stay at a participating dialysis facility for at least 6 months.
- The patient's physician(s) will allow the patient to participate.
- Ability to give informed consent.
Who cannot join
- Women must not be pregnant, breastfeeding, or plan to be pregnant during the course of the study.
- The presence of ongoing bleeding.
- The presence of a known bleeding disorder (e.g., hemophilia or von Willebrand's disease).
- Recent bleeding episode requiring transfusion within 12 weeks of entry.
- The presence of acute ulcer disease. Acute ulcer disease is defined as a new diagnosis of peptic disease including esophagitis, gastritis, or ulcer or the initiation of treatment with proton pump inhibitors, H2 blockers or therapy for Helicobacter pylori within three months prior to obtaining consent.
- A condition which prohibits discontinuation of anticoagulant drugs, aspirin, or nonsteroidal anti-inflammatory drugs during the six week study drug administration period. Use of heparin during dialysis is allowed.
Show all 18Show fewer
- Required use of oral or intravenous glucocorticoids at a dose greater than the equivalent of prednisone 15 mg per day during the six week study drug administration period.
- Current unstable angina.
- Required use of clopidogrel.
- Known hypersensitivity to clopidogrel.
- Medical considerations making anti-platelet therapy dangerous.
- Current uncontrolled hypertension with systolic blood pressure in excess of 200 mm Hg or diastolic blood pressure in excess of 115 mm Hg at the time of enrollment.
- Baseline platelet count less than 75,000/mm3.
- Known advanced liver disease with decompensated cirrhosis, jaundice, ascites or bleeding varices.
- Current problem with substance abuse.
- Concurrent participation in another medical intervention trial.
- Anticipated non-compliance with medical care based on physician judgment.
- Patient refusal.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston University Medical Center
Boston, Massachusetts, 02118
University of Texas Southwestern
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
University of Iowa
Iowa City, Iowa, 52242
Vanderbilt University
Nashville, Tennessee, 37232
Maine Medical Center
Portland, Maine, 04102
Washington University
St Louis, Missouri, 63110
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Effect of Clopidogrel on Early Failure of Arteriovenous Fistulas for Hemodialysis
The objective of the study is to determine whether clopidogrel reduces the early failure rate of native AV fistulae. This study was originally registered as NCT00067119 which included two protocols, this one and the GRAFT study)
- Conditions
- Kidney Failure, Hemodialysis Fistula Thrombosis
- Being tested
- Clopidogrel, Placebo
- Keywords
- Access Blood Flow Monitoring, Clinical Trial Vascular Access, Fistula Failure, Hemodialysis, Vascular Access
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Experimental | Not described Receives: Drug: Clopidogrel |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula thrombosis (patency failure)
The fistula was classified as patent if a bruit was audible with a stethoscope throughout systole and diastole at least 8 cm proximal to the arteriovenous anastomosis. Fistula patency was assessed by trained study personnel.
Measured: 6 weeks
Secondary outcomes (1)
Failure to attain suitability for dialysis (ability to use the fistula for dialysis with 2 needles and maintain a dialysis machine blood flow rate adequate for optimal dialysis (>=300 mL/min))
Fistula suitability was defined as the ability to use the fistula for dialysis with 2 needles and maintain a dialysis machine blood flow rate adequate for optimal dialysis (>=300 mL/min) during 8 of 12 dialysis sessions occurring during a 30-day suitability ascertainment period. For participants receiving maintenance hemodialysis at the time of enrollment and for participants who started maintenance hemodialysis within 120 days after fistula creation, the suitability ascertainment period began between 120 and 150 days after fistula creation surgery.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start7 Jan 2003
- Primary completion18 Jun 2007
- Study completion18 Jun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 877 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- The Cleveland Clinic, Boston University, Duke University, University of Iowa, MaineHealth, University of Texas Southwestern Medical Center, University of Alabama at Birmingham, Washington University School of Medicine, Baystate Medical Center, Vanderbilt University, CAMC Health System, Emory University, St. Louis University, Tyler Nephrology Associates, Vascular Surgery Associates LLC
- Responsible party
- Sponsor
- Investigators
- John W Kusek, Ph.D., Study director, NIDDK - Telephone: 301-594-7717; Email: kusekj@ep.niddk.nih.govCatherine Meyers, M.D., Study director, NIDDK - Telephone: 301-451-4901; Email: meyersc@extra.niddk.nih.gov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289520
- Sponsor's protocol ID
- DAC Fistula
- Other IDs
- U01DK058982
- Acronym
- FISTULA
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2017
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository
Publications
Dember LM, Kaufman JS, Beck GJ, Dixon BS, Gassman JJ, Greene T, Himmelfarb J, Hunsicker LG, Kusek JW, Lawson JH, Middleton JP, Radeva M, Schwab SJ, Whiting JF, Feldman HI; DAC Study Group. Design of the Dialysis Access Consortium (DAC) Clopidogrel Prevention of Early AV Fistula Thrombosis Trial. Clin Trials. 2005;2(5):413-22. doi: 10.1191/1740774505cn118oa.
PubMed 16317810Dember LM, Beck GJ, Allon M, Delmez JA, Dixon BS, Greenberg A, Himmelfarb J, Vazquez MA, Gassman JJ, Greene T, Radeva MK, Braden GL, Ikizler TA, Rocco MV, Davidson IJ, Kaufman JS, Meyers CM, Kusek JW, Feldman HI; Dialysis Access Consortium Study Group. Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA. 2008 May 14;299(18):2164-71. doi: 10.1001/jama.299.18.2164.
PubMed 18477783Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
PubMed 35224730
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Clopidogrel on Early Failure of Arteriovenous Fistulas for Hemodialysis
- ClinicalTrials.gov ID
- NCT03289520
- Acronym / sponsor ID
- FISTULA / DAC Fistula
- Conditions
- Kidney Failure, Hemodialysis Fistula Thrombosis
- Keywords
- Access Blood Flow Monitoring, Clinical Trial Vascular Access, Fistula Failure, Hemodialysis, Vascular Access
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 877 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- The Cleveland Clinic, Boston University, Duke University, University of Iowa, MaineHealth, University of Texas Southwestern Medical Center, University of Alabama at Birmingham, Washington University School of Medicine, Baystate Medical Center, Vanderbilt University, CAMC Health System, Emory University, St. Louis University, Tyler Nephrology Associates, Vascular Surgery Associates LLC
- Study start
- 7 Jan 2003 (actual)
- Primary completion
- 18 Jun 2007 (actual)
- Study completion
- 18 Jun 2007 (actual)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to determine whether clopidogrel reduces the early failure rate of native AV fistulae. This study was originally registered as NCT00067119 which included two protocols, this one and the GRAFT study)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | Experimental | Drug: Clopidogrel |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-21 depending on state regulations
- Life expectancy of at least six months
- Chronic renal failure with anticipated start of hemodialysis within six months of enrollment, or current dialysis dependence
- Planned creation of native upper extremity AV fistula
- The patient is not on aspirin, or the patient is on aspirin but has not had a myocardial infarction or a cerebrovascular accident within the past 12 months.
Key exclusion criteria (18 listed)
- Women must not be pregnant, breastfeeding, or plan to be pregnant during the course of the study.
- The presence of ongoing bleeding.
- The presence of a known bleeding disorder (e.g., hemophilia or von Willebrand's disease).
- Recent bleeding episode requiring transfusion within 12 weeks of entry.
- The presence of acute ulcer disease. Acute ulcer disease is defined as a new diagnosis of peptic disease including esophagitis, gastritis, or ulcer or the initiation of treatment with proton pump inhibitors, H2 blockers or therapy for Helicobacter pylori within three months prior to obtaining consent.
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 |
|---|---|---|
| Clopidogrel | Drug | Clopidogrel |
| Placebo | Drug | Placebo |
Primary outcome
Fistula thrombosis (patency failure)
Time frame: 6 weeks
The fistula was classified as patent if a bruit was audible with a stethoscope throughout systole and diastole at least 8 cm proximal to the arteriovenous anastomosis. Fistula patency was assessed by trained study personnel.
1 secondary outcome
Failure to attain suitability for dialysis (ability to use the fistula for dialysis with 2 needles and maintain a dialysis machine blood flow rate adequate for optimal dialysis (>=300 mL/min))
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Background: PubMed 16317810Dember LM, Kaufman JS, Beck GJ, Dixon BS, Gassman JJ, Greene T, Himmelfarb J, Hunsicker LG, Kusek JW, Lawson JH, Middleton JP, Radeva M, Schwab SJ, Whiting JF, Feldman HI; DAC Study Group. Design of the Dialysis Access Consortium (DAC) Clopidogrel Prevention of Early AV Fistula Thrombosis Trial. Clin Trials. 2005;2(5):413-22. doi: 10.1191/1740774505cn118oa.
- Results publication: PubMed 18477783Dember LM, Beck GJ, Allon M, Delmez JA, Dixon BS, Greenberg A, Himmelfarb J, Vazquez MA, Gassman JJ, Greene T, Radeva MK, Braden GL, Ikizler TA, Rocco MV, Davidson IJ, Kaufman JS, Meyers CM, Kusek JW, Feldman HI; Dialysis Access Consortium Study Group. Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA. 2008 May 14;299(18):2164-71. doi: 10.1001/jama.299.18.2164.
- Derived from this study: PubMed 35224730Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
- Individual participant dataSharing planned: Yes. Data are available at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository
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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.
John W Kusek, Ph.D. study director
NIDDK - Telephone: 301-594-7717; Email: kusekj@ep.niddk.nih.gov
Catherine Meyers, M.D. study director
NIDDK - Telephone: 301-451-4901; Email: meyersc@extra.niddk.nih.gov
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clopidogrel in people with Kidney Failure and Hemodialysis Fistula Thrombosis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 9 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 8 inclusion and 18 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: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fistula thrombosis (patency failure) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03289520, which also lists 3 linked publications.
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 19 Sep 2025.