A trial to learn how well finerenone works and how safe it is in adult participants with non-diabetic chronic kidney disease
- Conditions
- on-diabetic chronic kidney diseaseMedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2021-000421-27-DK
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1584
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 <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.
2. 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
3. K+ = 4.8 mmol/L at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1133
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>- 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
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death<br>- Time to the composite of kidney failure or sustained eGFR decline of >= 57%<br>- Time to the composite to heart failure hospitalization or CV death<br>- 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)<br>- Up to End of Study visit ( up to approximately 47 months)<br>- Up to End of Study visit ( up to approximately 47 months)<br>- Up to approximately 48 months