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:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT00237718
Eligibility Criteria:
Inclusion Criteria:
1. Patients with end-stage renal disease receiving thrice weekly hemodialysis
2. Age \> 18 years
3. Life expectancy greater than one year
4. Ability to understand and provide informed consent for participation in the study
Exclusion Criteria:
1. AIDS (HIV seropositivity is not an exclusion criteria)
2. Active malignancy excluding basal cell carcinoma of the skin
3. Gastrointestinal dysfunction requiring parenteral nutrition
4. History of functional kidney transplant \< 6 months prior to study entry
5. Anticipated live donor kidney transplant over study duration
6. History of poor adherence to hemodialysis or medical regimen
7. Prisoners, patients with significant mental illness, pregnant women, and other vulnerable populations
8. Patients taking vitamin E supplements \> 60 IU/day, vitamin C \> 500 mg/day over the past 30 days
9. Patients taking anti-inflammatory medication except aspirin \< 325 mg/day over the past 30 days
10. Patients using a temporary catheter for dialysis access
11. More than two hospitalizations within the last 90 days or one hospitalization within the last 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00237718
Study Brief:
Protocol Section:
NCT00237718