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Home > "V" Clinical Trials Conditions > Vascular Access Clinical Trials Data Coordinating Center  Vascular Access Clinical Trials Data Coordinating Center
Vascular Access Clinical Trials Data Coordinating Center
For Condition: Kidney Failure
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , Cleveland Clinic Foundation Hospital,Boston University School of Medicine,Duke University,University of Iowa,Maine Medical Center,University of Texas,University of Alabama, Birmingham,Washington University School of Medicine
Synopsis: Fistula Study: The objective of the study is to determine whether clopidogrel reduces the early failure rate of native AV fistulae. Graft Study: The objective of the study is to determine whether Aggrenox (Boehringer-Ingelheim) prolongs primary unassisted patency in newly created arteriovenous grafts.
Details:
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Fistula Study Protocol Inclusion Criteria: - 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. Exclusion Criteria: - 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 dudring the six week study drug administration period. Use of heparin during dialysis is allowed. - Required use of oral or intravenous glucocorticoids at a dose greater than the equvalent 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. Graft Study Protocol Inclusion criteria: - 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 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. Exclusion Criteria: - 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). - 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.
Total Enrollment: 1284
Location and Contact Information:
Overall Study Official:
JohnKusek, Study Director, NIDDK - Telephone: 301-594-7717; Email: kusekj@ep.niddk.nih.gov
Boston University Medical Center *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Pat LeSage 617-414-1011
Washington University *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Rea Creaghan 314-362-7254
University of Iowa *Recruiting*
Iowa City, Iowa, 52242
United States
Recruiting Bradley Franzwa 319-353-6689
University of Texas Southwestern *Recruiting*
Dallas, Texas, 75390
United States
Recruiting Clara Ying 214-648-7847
Maine Medical Center *Recruiting*
Portland, Maine, 04102
United States
Recruiting Jane Kane 207-885-8235
University of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting Dot Gunter 205-975-6153
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Anne Quarles 919-660-6882
Additional Information:
Study ID Numbers: VACTDC;
Study Start Date: January 2003
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067119
Other Kidney Failure Studies:
1. Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis)
2. Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant
3. Vascular Access Clinical Trials Data Coordinating Center
4. Screening for Patients Needing Kidney, Kidney-Pancreas, or Islet-Cell Transplant
5. Sirolimus and Thymoglobulin to Prevent Kidney Transplant Rejection
Related Studies:
Other Kidney Failure Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Vascular Access Clinical Trials Data Coordinating Center
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