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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT02212327
Eligibility Criteria:
Inclusion Criteria:
Both subject groups:
* Age 18 to 80 years;
* BMI \< 40;
* Ability to give informed consent;
* Life expectancy greater than 6 months.
PD subjects:
* On peritoneal dialysis for greater than 3 months;
* Using glucose lactate-buffered PD solutions with consistent glucose exposure;
* Stable peritoneal prescription (Kt/V \> 1.7 or Tccr \> 50 ml/week/1.73 m2).
Control subjects:
* Estimated glomerular filtration rate (GFR) ≥ 60 ml/min/1.73m2;
* No proteinuria.
Exclusion Criteria (both subject groups):
* Pregnancy;
* Intolerance to study protocols;
* Severe, unstable, active, or chronic inflammatory disease (congestive heart failure-NY Class IV, active infection, active connective tissue disorder, active cancer or cancer history in the prior 5 years, HIV, liver disease, including active chronic hepatitis B or C);
* Active inflammatory conditions \[systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), minimal change disease (MCD)\];
* Patients prescribed or being treated with spironolactone;
* History of cirrhosis;
* Poor compliance with dialysis prescription.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02212327
Study Brief:
Protocol Section:
NCT02212327