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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT00825318
Eligibility Criteria:
Inclusion Criteria:
* Age greater than or equal to 18 years and less than or equal to 80 years
* Stable three treatments per week dialysis schedule for at least three months prior to beginning the study
* Residual renal clearance \<1.5ml/min per 35L of urea volume
* Pre-dialysis serum sodium levels of greater than 136 mEq/L
Exclusion Criteria:
* Non-compliance with hemodialysis treatments--defined as missing more than 1 treatment over the 3 month period prior to the study
* Unable to verbally communicate in English or Spanish
* Current requirement for hemodialysis more than three times per week due to medical comorbidity (including fourth session for ultrafiltration)
* Currently on daily or nocturnal hemodialysis, or less than 3 months since discontinued such treatment
* Expected geographic unavailability at dialysis center during any phase of the trial
* Less than 3 months since the patient returned after acute rejection resulting in allograft failure
* Currently in acute care or chronic care hospital
* Pregnancy
* Current involvement in any non-observational trial
* Unable or unwilling to follow the study protocol for any reason (including mental incompetence)
* Unable or unwilling to provide informed consent or sign IRB-approved consent form
* Pace maker, implantable pump, artificial joint
* Amputation of a limb
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00825318
Study Brief:
Protocol Section:
NCT00825318