Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis

Completed · Phase 2 · Has a placebo group

Conditions studied: End Stage Renal Failure on Dialysis, Complication of Hemodialysis

In brief

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 undergoing hemodialysis or whether they could increase the risk of heart problems. The purpose of the study is to measure certain chemicals in the blood and see how those chemicals may change during hemodialysis when certain drugs are given.

Key facts

Study ID

NCT00732069

Run by

Vanderbilt University

People needed

19

Starts

2008-08-01

Expected to finish

2011-12-01

Last updated by the study team

2013-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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