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

Phase 3

Active, not recruiting

• Conditions: Non-diabetic chronic kidney disease

• Registration Number: 2023-506897-11-00
• Lead Sponsor: Bayer AG

Brief Summary

To demonstrate that finerenone in addition to Standard of Care (SoC), is superior to placebo in delaying the progression of kidney disease.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-04-18
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 391

Inclusion Criteria

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 <90 mL/min/1.73m^2 at screening, and • Documentation of albuminuria/proteinuria in the participant's medical records at least 3 months prior to screening.

Stable and maximum tolerated labeled dose of an Angiotensin converting enzyme inhibitor (ACEI) or Angiotensin receptor blocker(ARB) for at least 4 weeks prior to screening

K+ ≤ 4.8 mmol/L at screening

Exclusion Criteria

Established diagnosis of Type 1 or 2 Diabetes mellitus, or HbA1c ≥ 6.5% (48 mmol/mol)

Autosomal dominant or autosomal recessive polycystic kidney disease

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

Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonist (MRA)s

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean rate of change as measured by the total slope of eGFR from baseline to Month-32.		Mean rate of change as measured by the total slope of eGFR from baseline to Month-32.

Secondary Outcome Measures

Name	Time	Method
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, 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 of kidney failure or sustained eGFR decline of >=57%
Time to the composite to heart failure hospitalization or CV death		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)		Number of participants with Treatment-emergent adverse event (TEAE)s, Treatment-emergent serious adverse event (TESAE)s and Adverse event of special interest (AESI)

Trial Locations

Locations (64)

Istituto Di Ricerche Farmacologiche Mario Negri; 🇮🇹 Ranica, Italy

Azienda Socio Sanitaria Territoriale Ovest Milanese; 🇮🇹 Legnano, Italy

Azienda USL IRCCS Di Reggio Emilia; 🇮🇹 Reggio Emilia, Italy

Azienda Ospedaliero Universitaria Di Modena; 🇮🇹 Modena, Italy

Azienda Ospedaliero Universitaria Parma; 🇮🇹 Parma, Italy

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico; 🇮🇹 Bologna, Italy

Azienda Socio Sanitaria Territoriale Rhodense; 🇮🇹 Garbagnate Milanese, Italy

Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione; 🇮🇹 Pavia, Italy

Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli; 🇮🇹 Naples, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy

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Istituto Di Ricerche Farmacologiche Mario Negri

🇮🇹Ranica, Italy

Aneliya Ilieva Parvanova

Site contact

+390354535306

aneliya.parvanova@marionegri.it