Date

2026-08-05

Protocol

Protocol changed

Item Changed

Exclusion criteria

Previous Version

Core protocol: Potential participants must have none of the following: 1. Currently receiving maintenance dialysis 2. Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months 3. Life expectancy less than 6 months MRA Domain-Specific Appendix: Potential participants must have none of the exclusion criteria in the Core Protocol, and must have none of the following: 1. Recipient of kidney transplant 2. Hyperkalaemia (serum potassium ?5.0 mmol/L) at time of screening 3. Current treatment with Mineralocorticoid Receptor Antagonist (MRA), where the treating physician or patient is not willing to discontinue this medication. If willing to discontinue the MRA, the potential participant must be re-screened after they have been on stable standard of care treatment for 4 weeks without the MRA. 4. Known allergy, intolerance or contraindication to MRAs 5. Current treatment with strong CYP3A4 inhibitors 6. Systolic Blood Pressure <110 mmHg or diastolic BP<55 mmHg without antihypertensive therapy at time of screening 7. Severe hepatic impairment 8. Adrenal insufficiency 9. Currently pregnant or breast feeding, or intending to become pregnant

Next Version

Core protocol: Potential participants must have none of the following: 1. Currently receiving maintenance dialysis 2. Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months 3. Life expectancy less than 6 months MRA Domain-Specific Appendix: Potential participants must have none of the exclusion criteria in the Core Protocol, and must have none of the following: 1. Recipient of kidney transplant 2. 2. Hyperkalaemia (serum potassium ?5.0 mmol/L) at time of screening 3. Current treatment with mineralocorticoid receptor antagonist (MRA), where the treating physician or patient is not willing to discontinue this medication 4. Known allergy, intolerance or contraindication to MRAs 5. Current treatment with strong CYP3A4 inhibitors 6. Systolic BP <110 mmHg or diastolic BP <55 mmHg without antihypertensive therapy at time of screening 7. Severe hepatic impairment (defined as Child-Pugh Class C) 8. Adrenal insufficiency 9. Currently pregnant or breast feeding, or intending to become pregnant