Diabetic Kidney Disease (DKD), Heart Failure
Conditions
Brief summary
To assess the effect of Finerinone on slowing renal function decline and improving cardiovascular outcomes, particularly heart failure risk, in patients with diabetic CKD.
Interventions
DRUGFinerenone
To assess the effect of Finerinone on slowing renal function decline and improving cardiovascular outcomes, particularly heart failure risk, in patients with diabetic CKD.
Sponsors
College of Physicians and Surgeons Pakistan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Serum potassium ≤4.8 mmol/L. * Provided written informed consent.
Exclusion criteria
* 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). * Serum potassium \>4.8 mmol/L or history of severe hyperkalaemia. * Contraindication or hypersensitivity to finerenone. * Pregnancy or lactation. * Any condition limiting compliance or follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Renal Function Decline post finerinone therapy | 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. |
| Number of Participants with Heart Failure (HF) Event post finerinone therapy | 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. |
| eGFR Measurement | 06 months | 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 | 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. |
| Number of Participants with Hyperkalaemia post treatment | 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. |
| Number of Participants with Cardiovascular (CV) Event post treatment with finerinone therapy | 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. |
Contacts
Primary ContactMuhammad Awais Danish, FCPS (Internal Medicine)
Outcome results
None listed