E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-diabetic chronic kidney disease |
Doença renal crónica não associada à diabetes |
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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 |
Doença renal crónica não associada à diabetes, uma doença do rim, de longa duração, que não é causada pela 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. |
Demonstrar que a finerenona, adicionada do padrão de tratamento, é superior ao placebo no adiamento da progressão da doença renal. |
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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 |
- Demonstrar o efeito benéfico da finerenona, adicionada ao padrão de tratamento, em comparação com placebo. - Avaliar a segurança da finerenona, adicionada ao padrão de tratamento, em comparação com 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/1.73m2 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 |
1. Diagnóstico clínico de doença renal crónica e: . Rácio albumina/creatinina na urina (RACU) ≥ 200 mg/g mas ≤ 3500 mg/g e taxa de filtração glomerular estimada (TFGe) ≥ 25 mas < 90 mL/min/1,73 m2 na visita de seleção, e . Documentação de albuminuria/proteinuria no registo médico do doente pelo menos 3 meses antes da seleção 2. Dose estável e máxima tolerada de um Inibidor da Enzima de Conversão da Angiotensina (IECA) ou Antagonista dos Recetores da Angiotensina (ARA) durante pelo menos 4 semanas antes da seleção 3. K+ ≤ 4,8 mmol/L na seleção
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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 |
1. Diagnóstico confirmado de Diabetes mellitus Tipo 1 ou 2, ou HbA1c ≥ 6,5% (48 mmol/mol) 2. Doença renal poliquística autossómica dominante ou autossómica recessiva 3. Nefrite lúpica ou vasculite associada a anticorpo citoplasmático anti-neutrofílico (ANCA) ou qualquer outra doença renal primária ou secundária que exija terapêutica imunossupressora no prazo de 6 meses antes da seleção 4. Insuficiência cardíaca sintomática com fração de ejeção reduzida com indicação de classe 1A para antagonistas dos recetores mineralocorticoides (ARM)
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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. |
Taxa média de variação medida pelo declínio total da TFGe desde o início do ensaio até ao Mês 32. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to month 32 |
Desde o início do ensaio até ao mês 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) |
- Tempo até ao composto de insuficiência renal, diminuição sustentada da TFGe ≥ 57%, hospitalização por insuficiência cardíaca ou morte de causa cardiovascular (CV) - Tempo até ao composto de insuficiência renal ou diminuição sustentada da TFGe ≥ 57% - Tempo até ao composto de hospitalização por insuficiência cardíaca ou morte de causa CV - Número de participantes com Acontecimentos adversos emergentes do tratamento (TEAE)s, Acontecimentos adversos graves emergentes do tratamento (TESAE)s e Acontecimentos adversos de especial interesse (AESI)s
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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 |
- Até à Consulta de Fim de Ensaio (até aproximadamente 47 meses) - Até à Consulta de Fim de Ensaio (até aproximadamente 47 meses) - Até à Consulta de Fim de Ensaio (até aproximadamente 47 meses) - Até aproximadamente 48 meses |
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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 | 5 |
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 |
Hong Kong |
India |
Israel |
Japan |
Korea, Republic of |
Malaysia |
Mexico |
Singapore |
Taiwan |
United States |
Bulgaria |
Spain |
Czechia |
Greece |
Italy |
Belgium |
Denmark |
Hungary |
Portugal |
Russian Federation |
United Kingdom |
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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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LVLS |
Última Consulta do Último Participante |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 10 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |