Finerenone for Cardiorenal Protection in Diabetic CKD: Impact on Renal Function Decline and Heart Failure

Primary outcomes

1. Number of Participants with Renal Function Decline post finerinone therapy

   Time frame: From enrollment to the end of treatment at 06 months

   Progressive worsening of kidney function is defined as a sustained ≥40% reduction in eGFR from baseline, progression to kidney failure (ESKD), or renal death.

2. Number of Participants with Heart Failure (HF) Event post finerinone therapy

   Time frame: 6 month

   Defined as hospitalization for new or worsening heart failure, confirmed by clinical evidence of fluid overload, raised BNP levels and the requirement for intravenous therapy or hemodynamic support.

3. eGFR Measurement

   Time frame: 06 months

   Estimated glomerular filtration rate calculated using the CKD-EPI formula, standardized for body surface area (mL/min/1.73 m²).

4. Number of Participants with Albuminuria

   Time frame: 06 months

   Measured as urinary albumin-to-creatinine ratio (UACR), with categories of moderately increased (30-300 mg/g) and severely increased (>300 mg/g) albuminuria, per KDIGO classification used in the trial protocols.

5. Number of Participants with Hyperkalaemia post treatment

   Time frame: 06 months

   Defined as a serum potassium level >5.5 mmol/L, which served as a safety threshold for dose adjustment or discontinuation in the parent trial data.

6. Number of Participants with Cardiovascular (CV) Event post treatment with finerinone therapy

   Time frame: 06 months

   Includes CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure (HHF) - forming the composite cardiovascular outcome measure in the finerenone studies.