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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT02427594
Eligibility Criteria:
Inclusion Criteria:
* estimated glomerular filtration rate ≥30 ml/min/1.73m2
* serum bicarbonate 20-28 mEq/L
Exclusion Criteria:
* diabetes mellitus
* uncontrolled hypertension or recent (\<3 weeks) titration of blood pressure medications
* clinically significant volume overload on screening physical examination
* selected medical conditions other than kidney disease and hypertension (active cancer, chronic liver failure, moderate to severe COPD, New York Heart Association class 2 or greater congestive heart failure, obstructive sleep apnea requiring nightly continuous positive airway pressure, solid organ transplant)
* use of alkali supplementation
* body mass index \<18.5 or \>40 kg/m2
* ideal body weight \<45.5 kg
* anemia at screening (hematocrit \<29% in participants with kidney disease or \<33% in healthy participants)
* pregnancy or breastfeeding
* allergies, intolerance or unwillingness to consume foods or supplement provided in feeding menu
* serum calcium less than 8.6 mg/dl on screening laboratories
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT02427594
Study Brief:
Protocol Section:
NCT02427594