Kidney FailurePhase 3GRAFTNCT00067119
Aggrenox Prevention of Access Stenosis
A Phase 3 study testing Aggrenox in people with Kidney Failure, 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 Aggrenox (Boehringer-Ingelheim) prolongs primary unassisted patency in newly created arteriovenous grafts. This record previously included information for both the GRAFT and FISTULA trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure
- What is being tested?
- Aggrenox
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 649 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Jan 2003to 31 Jan 2008
- 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
- A new or planned arteriovenous (AV) graft placed in any location for the purpose of hemodialysis. (Any type of graft material and any configuration of the access is acceptable).
- 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.
- Known allergy or adverse reaction to Aggrenox or any of its study components (dipyridamole and aspirin).
Show all 14Show fewer
- Required use of warfarin, dipyridamole, non-steroidal antiinflammatory drugs or other antiplatelet agents other than aspirin.
- Current uncontrolled hypertension with systolic blood pressure in excess of 200 mm Hg or diastolic blood pressure in excess of 115 mm Hg.
- 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 Dipyridamole Plus Aspirin on Hemodialysis Graft Patency
The objective of the study is to determine whether Aggrenox (Boehringer-Ingelheim) prolongs primary unassisted patency in newly created arteriovenous grafts. This record previously included information for both the GRAFT and FISTULA trials.
- Conditions
- Kidney Failure
- Being tested
- Aggrenox, Placebo
- Keywords
- Graft Failure, 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.
AggrenoxDrug
Also called Dipyridamole plus aspirin
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Aggrenox | Experimental | Not described Receives: Drug: Aggrenox |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2003 (estimated)
- Study start1 Jan 2003
- Primary completion31 Jan 2008
- Study completion31 Jan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 649 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
- NCT00067119
- Sponsor's protocol ID
- VAC GRAFT
- Other IDs
- U01DK058982
- Acronym
- GRAFT
- Status last verified
- Sep 2017
- First submitted
- 11 Aug 2003
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available at the National Institute of Diabetes Digestive and Kidney Diseases (NIDDK) Central Repository
Publications
Dixon BS, Beck GJ, Dember LM, Depner TA, Gassman JJ, Greene T, Himmelfarb J, Hunsicker LG, Kaufman JS, Lawson JH, Meyers CM, Middleton JP, Radeva M, Schwab SJ, Whiting JF, Feldman HI; DAC Study Group. Design of the Dialysis Access Consortium (DAC) Aggrenox Prevention Of Access Stenosis Trial. Clin Trials. 2005;2(5):400-12. doi: 10.1191/1740774505cn110oa.
PubMed 16317809Dixon BS, Beck GJ, Vazquez MA, Greenberg A, Delmez JA, Allon M, Dember LM, Himmelfarb J, Gassman JJ, Greene T, Radeva MK, Davidson IJ, Ikizler TA, Braden GL, Fenves AZ, Kaufman JS, Cotton JR Jr, Martin KJ, McNeil JW, Rahman A, Lawson JH, Whiting JF, Hu B, Meyers CM, Kusek JW, Feldman HI; DAC Study Group. Effect of dipyridamole plus aspirin on hemodialysis graft patency. N Engl J Med. 2009 May 21;360(21):2191-201. doi: 10.1056/NEJMoa0805840.
PubMed 19458364Natale 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 35224730Mohamed I, Kamarizan MFA, Da Silva A. Medical adjuvant treatment to increase patency of arteriovenous fistulae and grafts. Cochrane Database Syst Rev. 2021 Jul 23;7(7):CD002786. doi: 10.1002/14651858.CD002786.pub4.
PubMed 34298589Dember 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 18477783
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dipyridamole Plus Aspirin on Hemodialysis Graft Patency
- ClinicalTrials.gov ID
- NCT00067119
- Acronym / sponsor ID
- GRAFT / VAC GRAFT
- Conditions
- Kidney Failure
- Keywords
- Graft Failure, Access Blood Flow Monitoring, Clinical Trial Vascular Access, Fistula Failure, Hemodialysis, Vascular Access
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 649 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
- 1 Jan 2003 (actual)
- Primary completion
- 31 Jan 2008 (actual)
- Study completion
- 31 Jan 2008 (actual)
- First posted
- 13 Aug 2003 (estimated)
- 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 Aggrenox (Boehringer-Ingelheim) prolongs primary unassisted patency in newly created arteriovenous grafts. This record previously included information for both the GRAFT and FISTULA trials.
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 |
|---|---|---|
| Aggrenox | Experimental | Drug: Aggrenox |
| 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 (7 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
- A new or planned arteriovenous (AV) graft placed in any location for the purpose of hemodialysis. (Any type of graft material and any configuration of the access is acceptable).
- The patient is expected to stay at a participating dialysis facility for at least 6 months.
Key exclusion criteria (14 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 |
|---|---|---|
| AggrenoxAlso: Dipyridamole plus aspirin | Drug | Aggrenox |
| Placebo | Drug | Placebo |
Primary outcome
Not reported in the source record.
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 2017.
- Background: PubMed 16317809Dixon BS, Beck GJ, Dember LM, Depner TA, Gassman JJ, Greene T, Himmelfarb J, Hunsicker LG, Kaufman JS, Lawson JH, Meyers CM, Middleton JP, Radeva M, Schwab SJ, Whiting JF, Feldman HI; DAC Study Group. Design of the Dialysis Access Consortium (DAC) Aggrenox Prevention Of Access Stenosis Trial. Clin Trials. 2005;2(5):400-12. doi: 10.1191/1740774505cn110oa.
- Results publication: PubMed 19458364Dixon BS, Beck GJ, Vazquez MA, Greenberg A, Delmez JA, Allon M, Dember LM, Himmelfarb J, Gassman JJ, Greene T, Radeva MK, Davidson IJ, Ikizler TA, Braden GL, Fenves AZ, Kaufman JS, Cotton JR Jr, Martin KJ, McNeil JW, Rahman A, Lawson JH, Whiting JF, Hu B, Meyers CM, Kusek JW, Feldman HI; DAC Study Group. Effect of dipyridamole plus aspirin on hemodialysis graft patency. N Engl J Med. 2009 May 21;360(21):2191-201. doi: 10.1056/NEJMoa0805840.
- 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.
- Derived from this study: PubMed 34298589Mohamed I, Kamarizan MFA, Da Silva A. Medical adjuvant treatment to increase patency of arteriovenous fistulae and grafts. Cochrane Database Syst Rev. 2021 Jul 23;7(7):CD002786. doi: 10.1002/14651858.CD002786.pub4.
- Derived from this study: 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.
- Individual participant dataSharing planned: Yes. Data will be available at the National Institute of Diabetes 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 Aggrenox in people with Kidney Failure, 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 7 inclusion and 14 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 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00067119, which also lists 5 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 2017.