About this trial
To assess the effect of Finerinone on slowing renal function decline and improving cardiovascular outcomes, particularly heart failure risk, in patients with diabetic CKD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥18 years.
Diagnosed cases of type 2 diabetes mellitus.
Chronic kidney disease with eGFR 25-90 mL/min/1.73m² and/or UACR ≥30 mg/g.
On stable ACE inhibitor or ARB therapy for at least 4 weeks.
Disqualifiers
Symptomatic heart failure (NYHA class II-IV).
eGFR <25 mL/min/1.73m² or on maintenance dialysis.
Known non-diabetic kidney disease.
Recent major cardiovascular event (within 30 days).
Trial design
Single group
Treatments tested in this trial
Finerenone
DrugTo assess the effect of Finerinone on slowing renal function decline and improving cardiovascular outcomes, particularly heart failure risk, in patients with diabetic CKD.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
eGFR Measurement
Estimated glomerular filtration rate calculated using the CKD-EPI formula, standardized for body surface area (mL/min/1.73 m²).
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.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
College of Physicians and Surgeons Pakistan
Lead sponsor
Nishtar Medical University
Sponsor institution
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