MRA DSA Synopsis – Captivate Trial

Intervention(s)

The outcomes detailed in the Core Protocol apply to this DSA, with the following MRA DSA-specific details:

Primary outcome: Chronic eGFR slope estimated from all available eGFR values from week 4 to the end of treatment.

In addition, the MRA DSA has a domain-specific secondary outcome of time to the composite of ≥57% eGFR decline or kidney failure.

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 (22.6 mg/mmol) or urine protein-creatinine ratio (uPCR) >300 mg/g (33.9 mg/mmol) at time of screening.
 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.
Provision of written informed consent or eConsent following a fully informed discussion and prior to performing any MRA DSA related procedures

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

Maximum sample size of approximately 1000 participants.