Intervention(s)
- Finerenone
- Matched placebo
DSA-Specific objective
The objectives detailed in the Core Protocol apply to this DSA. In addition, the MRA DSA has a domain-specific secondary objective to determine the effect of the interventions on the time to the composite of ≥57% eGFR decline or kidney failure.
Inclusion criteria
Potential participants must satisfy all of the inclusion criteria in the Core Protocol, and also satisfy the following:
- Urine albumin-creatinine ratio (uACR) >200 mg/g or urine protein-creatinine ratio (uPCR) >300 mg/g from the most recent result in the previous 3 months.
- On a stable standard of care treatment for CKD, including a SGLT2i unless there is a documented reason not to be using a SGLT2i, for 4 weeks before screening according to treating physician.
- Treating physician believes finerenone is clinically appropriate for the participant.
- Participant and treating physician are willing and able to perform MRA DSA procedures.
Exclusion criteria
Potential participants must have none of the exclusion criteria in the Core Protocol, and must have none of the following:
- Recipient of kidney transplant
- Hyperkalaemia (serum potassium ≥5.0 mmol/L) at time of screening
- Current treatment with mineralocorticoid receptor antagonist (MRA), where the treating physician or patient is not willing to discontinue this medication
- Known allergy, intolerance or contraindication to MRAs
- Current treatment with strong CYP3A4 inhibitors
- Systolic BP <110 mmHg or diastolic BP <55 mmHg without antihypertensive therapy at time of screening
- Severe hepatic impairment (defined as Child-Pugh Class C)
- Adrenal insufficiency
- Currently pregnant or breast feeding, or intending to become pregnant
Number of participants
Maximum sample size of approximately 1000 participants.
DSA-Specific outcome measure
The outcomes detailed in the Core Protocol apply to this DSA. In addition, the MRA DSA has a domain-specific secondary outcome of time to the composite of ≥57% eGFR decline or kidney failure.