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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT06884267
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years, at the time of signing the informed consent.
2. HK (sK+ \> 5.0 mmol/L) within 48 hours before enrolment.
3. Patients diagnosed as chronic kidney disease with eGFR\>10 ml/min/1.73m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2021). See 8.3.4 for detailed equation.
4. Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion Criteria:
1. Patients on dialysis.
2. Pseudohyperkalemia signs and symptoms, such as hemolyzed blood specimen due to excessive fist clenching to make veins prominent, difficult or traumatic venipuncture, or history of severe leukocytosis or thrombocytosis.
3. Patients with acute kidney injury (AKI) or diabetic ketoacidosis (DKA).
4. Patients with cardiac arrhythmias that require immediate treatment
5. Patients scheduled for renal transplant or with a history of renal transplant.
6. Life expectancy \< 48 weeks.
7. History of malignancy except for:
7.1 Malignancy treated with curative intent and with no known active disease within 3 years before the enrolment and of low potential risk for recurrence.
7.2 Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease.
7.3 Adequately treated carcinoma in situ without evidence of disease.
8. Be participating in other intervention clinical trials.
9. Judgment by the HCP that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06884267
Study Brief:
Protocol Section:
NCT06884267