To assess the effect of Finerinone on slowing renal function decline and improving cardiovascular outcomes, particularly heart failure risk, in patients with diabetic CKD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
120
To assess the effect of Finerinone on slowing renal function decline and improving cardiovascular outcomes, particularly heart failure risk, in patients with diabetic CKD.
Number of Participants with Renal Function Decline post finerinone therapy
Progressive worsening of kidney function is defined as a sustained ≥40% reduction in eGFR from baseline, progression to kidney failure (ESKD), or renal death.
Time frame: From enrollment to the end of treatment at 06 months
Number of Participants with Heart Failure (HF) Event post finerinone therapy
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.
Time frame: 6 month
eGFR Measurement
Estimated glomerular filtration rate calculated using the CKD-EPI formula, standardized for body surface area (mL/min/1.73 m²).
Time frame: 06 months
Number of Participants with Albuminuria
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.
Time frame: 06 months
Number of Participants with Hyperkalaemia post treatment
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.
Time frame: 06 months
Number of Participants with Cardiovascular (CV) Event post treatment with finerinone therapy
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.
Time frame: 06 months
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