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

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 Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Diabetic Kidney Disease (DKD)
• Intervention / Treatment: Drug: Finerenone

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Awais Danish, FCPS (Internal Medicine); Phone Number: 923037589797; Email: raoawaisdanish@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Finerenone Group; Finerenone Drug	Drug: Finerenone; To assess the effect of Finerinone on slowing renal function decline and improving cardiovascular outcomes, particularly heart failure risk, in patients with diabetic CKD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 month
eGFR Measurement	Estimated glomerular filtration rate calculated using the CKD-EPI formula, standardized for body surface area (mL/min/1.73 m²).	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.	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.	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.	06 months

Collaborators and Investigators

• Sponsor: College of Physicians and Surgeons Pakistan

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Cardiovascular Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Diabetes Mellitus; Diabetes Complications; Heart Failure; Diabetic Nephropathies; finerenone
• Other Study ID Numbers: 22126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No