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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCollege of Physicians and Surgeons Pakistan

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Finerenone

    Drug

    To 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

120 Participants
are divided into 1 treatment group
Group A: Finerenone GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Locations

This trial has no 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

This trial is not recruiting at the moment. You can still explore other options: