Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT00732069
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00732069
Study Brief:
Protocol Section:
NCT00732069