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 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
NCT ID:
NCT05786469
Eligibility Criteria:
Inclusion Criteria:
1. Provision of informed consent prior to any study-specific procedures.
2. Age \>18 years.
3. GFR \<45 ml/min/1.73m2 as per CKD-EPI equation.
4. Serum potassium ≥5.0 mEq/L (in at least two consecutive evaluations, one week apart) despite dietary counseling, optimized metabolic acidosis control, diuretic therapy as needed for blood pressure control and fluid balance, and effective blood glucose control in diabetics.
5. Concomitant therapy with RAAS inhibitors (ACE inhibitors, ARBs and aldosterone antagonists, such as spironolactone and finerenone).
Exclusion Criteria:
1. Ongoing treatment with SPS before randomization (Patient eligibility could be reassessed during the screening period after at least one week from SPS therapy withdrawal)
2. Rapidly progressive kidney disease (eGFR reduction ≥ 30% over the last three months as per CKD-Epi equation) and expected risk of progression to ESKD and need of renal replacement therapy by dialysis or transplantation within six months.
3. Active systemic autoimmune diseases.
4. Concomitant treatment with steroids or any other immunosuppressive agent.
5. Hypersensitivity to the active ingredient or any of the excipients. Patients with Hereditary Fructose Intolerance.
6. Patients with or at risk of hypercalcaemia and/or hypomagnesaemia.
7. Severe/unstable heart failure with or without decreased systolic function requiring hospitalization or changes in pharmacological therapy over the last three months.
8. Refractory severe hypertension (BP \>180/100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications and a diuretic).
9. Positive hepatitis C antibodies, hepatitis B virus surface antigens at screening.
10. Known to have tested positive for human immunodeficiency virus.
11. Drug or alcohol abuse.
12. Female subjects who are pregnant, lactating or who intend to become pregnant before or during the study period, or within 90 days of the last dose of study treatment. Female subjects who intend to donate ova over the same time period.
13. Male subjects who intend to donate sperm during the study period or for the 90 days following the last dose of study treatment.
14. Male and female subjects in childbearing age not using a highly effective contraception method according to the 2020 CTFG Recommendations related to contraception and pregnancy testing in clinical trials (9)
15. Inability to fully understand the potential risks and benefits related to study participation.
16. Involvement in the study planning and/or conduct.
17. Participation in another clinical study with an investigational product during the last month.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05786469
Study Brief:
Protocol Section:
NCT05786469