Phase
Condition
Focal Segmental Glomerulosclerosis
Renal Failure
Kidney Failure (Pediatric)
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ofenrollment, or current dialysis dependence
A new or planned arteriovenous (AV) graft placed in any location for the purpose ofhemodialysis. (Any type of graft material and any configuration of the access isacceptable).
The patient is expected to stay at a participating dialysis facility for at least 6months.
The patient's physician(s) will allow the patient to participate.
Ability to give informed consent.
Exclusion
Exclusion Criteria:
Women must not be pregnant, breastfeeding, or plan to be pregnant during the course ofthe study.
The presence of ongoing bleeding.
The presence of a known bleeding disorder (e.g., hemophilia or von Willebrand'sdisease).
Recent bleeding episode requiring transfusion within 12 weeks of entry.
The presence of acute ulcer disease. Acute ulcer disease is defined as a new diagnosisof peptic disease including esophagitis, gastritis, or ulcer or the initiation oftreatment with proton pump inhibitors, H2 blockers or therapy for Helicobacter pyloriwithin 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 otherantiplatelet agents other than aspirin.
Current uncontrolled hypertension with systolic blood pressure in excess of 200 mm Hgor 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 orbleeding 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.
Study Design
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
University of Iowa
Iowa City, Iowa 52242
United StatesSite Not Available
Maine Medical Center
Portland, Maine 04102
United StatesSite Not Available
Boston University Medical Center
Boston, Massachusetts 02118
United StatesSite Not Available
Washington University
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University
St. Louis, Missouri 63110
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Wake Forest University
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Vanderbilt University
Nashville, Tennessee 37232
United StatesSite Not Available
University of Texas Southwestern
Dallas, Texas 75390
United StatesSite Not Available
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