A trial to learn how well finerenone works and how safe it is in adult participants with non-diabetic chronic kidney disease

A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of FInerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease - FIND-CKD

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000421-27-CZ

Enrollment

1580

Registered

2021-07-23

Start date

2021-10-04

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-diabetic chronic kidney disease MedDRA version: 23.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Product Name: Finerenone Product Code: BAY94-8862 10mg Pharmaceutical Form: Coated tablet INN or Proposed INN: FINERENONE CAS Number: 1050477-31-0 Current Sponsor code: BAY94-8862 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. A clinical diagnosis of chronic kidney disease and: • Urine albumin/creatinine ratio (UACR) of = 200 but = 3500 mg/g and estimated glomerular filtration rate (eGFR) =25 but =65 years) yes F.1.3.1 Number of subjects for this age range 474

Exclusion criteria

Exclusion criteria: 1. Established diagnosis of Type 1 or 2 Diabetes mellitus, or HbA1c = 6.5% (48 mmol/mol) 2. Autosomal dominant or autosomal recessive polycystic kidney disease 3. Lupus nephritis or anti-neutrophilic cytoplasmic autoantibody (ANCA) -associated vasculitis or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening 4. Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonist (MRA)s

Design outcomes

Primary

Measure	Time frame
Main Objective: - To demonstrate that finerenone in addition to Standard of Care (SoC), is superior to placebo in delaying the progression of kidney disease.;Secondary Objective: - To demonstrate the beneficial effect of finerenone in addition to SoC as compared to placebo. - To assess the safety of finerenone in addition to SoC as compared to placebo;Primary end point(s): - Mean rate of change as measured by the total slope of eGFR from baseline to Month-32.;Timepoint(s) of evaluation of this end point: From baseline to month 32	—

Measure

Time frame

Main Objective: - To demonstrate that finerenone in addition to Standard of Care (SoC), is superior to placebo in delaying the progression of kidney disease.;Secondary Objective: - To demonstrate the beneficial effect of finerenone in addition to SoC as compared to placebo. - To assess the safety of finerenone in addition to SoC as compared to placebo;Primary end point(s): - Mean rate of change as measured by the total slope of eGFR from baseline to Month-32.;Timepoint(s) of evaluation of this end point: From baseline to month 32

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Secondary

Measure	Time frame
Secondary end point(s): - Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death - Time to the composite of kidney failure or sustained eGFR decline of >= 57% - Time to the composite to heart failure hospitalization or CV death - Number of participants with Treatment-emergent adverse event (TEAE)s, Treatment-emergent serious adverse event (TESAE)s and Adverse event of special interest (AESI);Timepoint(s) of evaluation of this end point: - Up to End of Study visit ( up to approximately 47 months) - Up to End of Study visit ( up to approximately 47 months) - Up to End of Study visit ( up to approximately 47 months) - Up to approximately 48 months	—

Measure

Time frame

Secondary end point(s): - Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death - Time to the composite of kidney failure or sustained eGFR decline of >= 57% - Time to the composite to heart failure hospitalization or CV death - Number of participants with Treatment-emergent adverse event (TEAE)s, Treatment-emergent serious adverse event (TESAE)s and Adverse event of special interest (AESI);Timepoint(s) of evaluation of this end point: - Up to End of Study visit ( up to approximately 47 months) - Up to End of Study visit ( up to approximately 47 months) - Up to End of Study visit ( up to approximately 47 months) - Up to approximately 48 months

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Countries

Argentina, Australia, Belgium, Bulgaria, China, Czechia, Czech Republic, Denmark, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Portugal, Russian Federation, Spain, Taiwan, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer AG

clinical-trials-contact@bayer.com004930300139003

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026