Status:
COMPLETED
Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
End Stage Renal Failure on Dialysis
Complication of Hemodialysis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Little is known about how some drugs affect inflammation or clotting factors in people receiving hemodialysis. It is not yet known if these drugs help prevent heart damage as they do in people not und...
Detailed Description
* Cardiovascular disease in the leading cause of death in patients with chronic kidney disease undergoing hemodialysis. * Traditional risk factors do not adequately predict cardiovascular morbidity an...
Eligibility Criteria
Inclusion
- Age 18 years or older
- On thrice-weekly chronic hemodialysis for at least 6 months
- Clinically stable, adequately dialyzed (single-pool Kt/V\> 1.2) thrice weekly, with polysulphone membrane for at least 3 consecutive months prior to study
Exclusion
- Body mass index \> 35 mg/kg
- History of functional transplant less than 6 months prior to study
- Use of anti-inflammatory medications other than aspirin \< 325 mg/d
- History of active connective tissue disease
- History of acute infectious disease within one month prior to study
- AIDS (HIV seropositivity is not an exclusion criteria)
- History of myocardial infarction or cerebrovascular event within 3 months
- Advanced liver disease
- Gastrointestinal dysfunction requiring parental nutrition
- Active malignancy excluding basal cell carcinoma of the skin
- History of ACE inhibitor-associated cough or angioedema
- Ejection fraction less than 40%
- Inability to discontinue ACE inhibitor or ARB
- Predialysis potassium repeatedly higher than 5.5 mmol/L (confirmed on a repeated blood draw)
- Anticipated live donor kidney transplant
- Use of vitamin E \>60 IU/d or vitamin C \>500 mg/d
- Pregnancy, breast-feeding or child-bearing potential
- History of poor adherence to hemodialysis or medical regimen
- Inability to provide consent
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00732069
Start Date
August 1 2008
End Date
December 1 2011
Last Update
July 2 2013
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37323