Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 3

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Oxidative Stress, Endothelial Dysfunction

In brief

The purpose of the study is to see how two classes of blood pressure medications,angiotensin-converting enzyme inhibitors (Ace inhibitors) and angiotensin receptor blockers (ARBs), differ in their long term effects on certain chemicals in the body and on the carotid arteries.

Key facts

Study ID

NCT00878969

Run by

Vanderbilt University

People needed

78

Starts

2010-01-01

Expected to finish

2015-06-01

Last updated by the study team

2016-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: 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 or Urea Reduction Ratio (URR) > 65%] thrice weekly, with polysulphone membrane for at least 3 consecutive months prior to study

You may not qualify if…

• History of functional transplant less than 6 months prior to study
• Use of immunosuppressive drugs within 1 month prior to study
• 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 (intolerable) or angioedema
• Ejection fraction less than 30%
• Inability to discontinue ACE inhibitor or ARB
• Predialysis potassium repeatedly higher than 6.0 mmol/L (confirmed on a repeated blood draw)
• Anticipated live donor kidney transplant
• Pregnancy or breast-feeding
• 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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