A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease

JRCT ID: jRCT2031210398

Registered date:29/10/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-diabetic Chronic Kidney Disease
• Date of first enrollment: 10/11/2021
• Target sample size: 1580
• Countries of recruitment: United States,Japan,Argentina,Japan,Australia,Japan,Bulgaria,Japan,China,Japan,Czechia,Japan,Denmark,Japan,Greece,Japan,Hong Kong,Japan,India,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Malaysia,Japan,Mexico,Japan,Russian Federation,Japan,Spain,Japan,Taiwan,Japan,Belgium,Japan,United Kingdom,Japan,Hungary,Japan,Portugal,Japan,Singapore,Japan
• Study type: Interventional

Intervention(s)

- Drug: Finerenone (BAY94-8862)
Tablet, 10 mg or 20 mg, once daily (OD), oral
- Drug: Placebo
Tablet, once daily, oral

Outcome(s)

Primary Outcome

1. Mean rate of change as measured by the total slope of eGFR from baseline to Month-32. [ Time Frame: From baseline to month 32 ]
eGFR: Estimated glomerular filtration rate

Secondary Outcome

1. Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death [ Time Frame: Up to end of study visit (up to approximately 49 months) ]
2. Time to the composite of kidney failure or sustained eGFR decline of >= 57% [ Time Frame: Up to end of study visit (up to approximately 49 months) ]
3. Time to the composite to heart failure hospitalization or CV death [ Time Frame: Up to end of study visit (up to approximately 49 months) ]
4. Number of participants with Treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse events (TESAEs) and Adverse events of special interest (AESI) [ Time Frame: Up to approximately 50 months ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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/1.73m2 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

Exclude 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 antagonists (MRAs)

Related Information

• Primary Sponsor: Myoishi Masashi
• Secondary ID(s): NCT05047263