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:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT06237712
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (≥ 18 years)
* CKD G3b or G4 (44 - 15 ml/min/1.73 m2)
* Use of RAAS-I (ACE-inhibitor or angiotensin receptor blocker, ARB)
Exclusion Criteria:
* Use of any of the following drugs or supplements: mineralocorticoid receptor antagonists, potassium-sparing diuretics, oral potassium binders, immunosuppressive medication, tolvaptan, acetazolamide, topiramate, sodium bicarbonate.
* Patients using double RAAS blockade (i.e., ACE-inhibitor + ARB).
* Metabolic alkalosis (plasma bicarbonate \>27 mmol/L) at last outpatient visit
* Kidney transplant recipients
* Patients with an active gastro-intestinal ulcer
* Patients with previous history of ventricular cardiac arrhythmia
* Patients with a life expectancy \< 6 months
* Incapacitated subjects or subjects who are deemed unfit to adequately adhere to instructions from the research team
* Women who are pregnant, breastfeeding or consider pregnancy in the coming 7 weeks
* Patients with chronic respiratory acidosis in previous medical history
* Hyperkalemia (plasma potassium \>5.5 mmol/L) at V0
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06237712
Study Brief:
Protocol Section:
NCT06237712