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 @ 12:50 PM
Ignite Modification Date:
2025-12-24 @ 12:50 PM
NCT ID:
NCT01437761
Eligibility Criteria:
Inclusion Criteria:
* age \</=18 years
* end-stage renal disease (ESRD) patient on chronic high-flux hemodialysis for \</= 6 months at time of enrollment
* well-functioning fistula, graft or catheter as hemodialysis access, achieving blood flow rates of \>/= 300 mL/min
* ability to understand the English language
Exclusion Criteria:
* Pre-dialysis serum blood urea nitrogen (BUN) concentration below 30 mg/dL in the last three months
* Severe Coronary Heart Disease or Heart Failure (New York Heart Association class IV)
* Active Infections
* Hepatitis B
* Any other active infection that has required antibiotic treatment in the preceding eight weeks
* Pre-study lab values of any of the following (in the most recent routine lab work)
* Sodium - Na+ \> 150 mmol/L, Na+ \< 132 mmol/L
* Potassium - K+ \> 6.5 mmol/L, K+ \< 3.5 mmol/L
* Total Calcium - Ca \> 12 mg/dL (3 mmol/L), total Ca \< 7.2 mg/dL (1.8 mmol/L)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
88 Years
Study:
NCT01437761
Study Brief:
Protocol Section:
NCT01437761