NCT07326631

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

December 9, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 9, 2025

Last Update Submit

December 24, 2025

Conditions

Heart FailureDiabetic Kidney Disease (DKD)

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (1)

Finerenone Group

EXPERIMENTAL

Finerenone Drug

Drug: Finerenone

Interventions

FinerenoneDRUG

To assess the effect of Finerinone on slowing renal function decline and improving cardiovascular outcomes, particularly heart failure risk, in patients with diabetic CKD.

Finerenone Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Diabetic NephropathiesHeart Failure

Interventions

finerenone

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Muhammad Awais Danish, FCPS (Internal Medicine)

CONTACT

923037589797raoawaisdanish@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 9, 2025

First Posted

January 8, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 8, 2026

Record last verified: 2025-12