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:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT07181135
Eligibility Criteria:
Main Inclusion Criteria:
1. Adults (≥18 years) with Chronic Kidney Disease defined as:
* eGFR ≥25 and \<120 mL/min/1.73 m2 using CKD-EPI 2009 formula at the Screening visit.
* UACR ≥100 mg/g (11.3 mg/mmol) to \<5000 mg/g (565 mg/mmol) at the Screening visit (geometric mean of the 3 measurements) and documentation of elevated albuminuria or proteinuria.
2. Potassium level ≤5.0 mmol/L at Screening (local assessment).
3. No current or previous (within 8 weeks prior to the Screening visit) treatment with RAS inhibition (ACEi, ARB, or Renin inhibitor (e.g. Aliskiren)).
Main Exclusion Criteria:
1. Participants with an HbA1c\>11%.
2. Participants with type 1 diabetes.
3. Symptomatic heart failure with reduced ejection fraction and class 1A indication for MRA treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07181135
Study Brief:
Protocol Section:
NCT07181135