E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-diabetic chronic kidney disease |
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E.1.1.1 | Medical condition in easily understood language |
Non-diabetic chronic kidney disease, a long-lasting kidney disease that is not caused by diabetes |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10064848 |
E.1.2 | Term | Chronic kidney disease |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To demonstrate that finerenone in addition to Standard of Care (SoC), is superior to placebo in delaying the progression of kidney disease. |
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E.2.2 | Secondary objectives of the trial |
- 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 <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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Mean rate of change as measured by the total slope of eGFR from baseline to Month-32. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to month 32 |
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E.5.2 | 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) |
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E.5.2.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 45 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
China |
India |
Israel |
Japan |
Malaysia |
Mexico |
United States |
Russian Federation |
Bulgaria |
Czechia |
Denmark |
Greece |
Italy |
Spain |
Hong Kong |
Korea, Republic of |
Taiwan |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |