Yükleniyor... / Loading...
This study examined the effect of the medicines Ramipril and Valsartan, compared with placebo, on inflammation and oxidative stress in patients on regular hemodialysis. It was open to clinically stable patients aged 18 and older who had been on thrice-weekly chronic hemodialysis for at least 6 months. Run by Vanderbilt University, the study was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * 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 Criteria: * 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