Status:
TERMINATED
Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 3
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Oxidative Stress
Endothelial Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 lon...
Detailed Description
More than 400,000 individuals with chronic kidney disease undergo hemodialysis each year in the United States. Atherosclerotic cardiovascular disease is the leading cause of mortality in these patient...
Eligibility Criteria
Inclusion
- Age 18 years or older
- On thrice weekly chronic hemodialysis for at least 6 months
- Clinically stable, adequately dialyzed \[single-pool Kt/V \> 1.2 or Urea Reduction Ratio (URR) \> 65%\] thrice weekly, with polysulphone membrane for at least 3 consecutive months prior to study
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00878969
Start Date
January 1 2010
End Date
June 1 2015
Last Update
February 15 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232