E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-diabetic chronic kidney disease |
Malattia renale cronica non diabetica |
|
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 |
Malattia renale cronica non causata da diabete |
|
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 |
|
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 |
Dimostrare che il finerenone, in aggiunta al SoC, è superiore al placebo nel ritardare la progressione della malattia renale |
|
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 |
-Dimostrare l'effetto benefico del finerenone in aggiunta al SoC rispetto al placebo -Valutare la sicurezza del finerenone in aggiunta al SoC rispetto al placebo |
|
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 Angiotensinconverting enzyme inhibitor (ACEI) or Angiotensin receptor blocker(ARB) for at least 4 weeks prior to screening 3. K+ = 4.8 mmol/L at screening |
• Uomini o donne di età = 18 anni • Soggetti con diagnosi clinica di malattia renale cronica in base ai seguenti criteri alla visita di screening o UACR persistente = 200-500 mg/g ed eGFR 25-60 ml/min/1,73 m2* (CKD-EPI) OPPURE o UACR persistente = 500 mg/g ed eGFR 25-90 ml/min/1,73 m2 (CKD-EPI) • Assunzione costante della dose massima tollerata di un ACE-i o di un ARB per almeno 4 settimane prima dello screening • K+ = 4,8 mmol/l *Al massimo il 10% di tutti i pazienti arruolati con UACR = 200-500 mg/g ed eGFR 25-60 mL/min/1,73 m2 (CKD-EPI) per garantire un rapporto pre-specificato da dedicare a una popolazione a rischio da moderato a elevato di peggioramento progressivo della funzionalità renale |
|
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 |
• Diabete mellito di tipo 2 e 1 • Malattia renale policistica autosomica dominante o autosomica recessiva, nefrite lupica o vasculite ANCA-associata • Qualsiasi altra malattia renale primaria o secondaria che necessiti di terapia immunosoppressiva nei 6 mesi precedenti allo screening • Anamnesi di trapianto di organi • Danno renale acuto (AKI) e dialisi nei 6 mesi precedenti allo screening • Pressione arteriosa sistolica = 160 mmHg, pressione arteriosa diastolica = 100 mmHg allo screening • Insufficienza cardiaca sintomatica con frazione di eiezione ridotta con un'indicazione di classe 1A per gli antagonisti del recettore dei mineralcorticoidi (MRA) • UACR > 3.500 mg/g |
|
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 |
• Tasso medio di variazione misurato in base alla curva totale dell'eGFR dal basale al Mese 32 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to month 32 |
Da basale a mese 32 |
|
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 per il raggiungimento della combinazione di insufficienza renale, peggioramento continuato dell'eGFR = 57%, ricovero per HF o morte CV • Tempo per il raggiungimento della combinazione di insufficienza renale o peggioramento continuato dell'eGFR = 57% • Tempo per il raggiungimento della combinazione di ricovero per HF o morte CV • Numero di partecipanti con TEAE, TESAE e AESI |
|
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 |
- Fino a Visita di fine studio ( fino a circa 47 mesi) - Fino a Visita di fine studio ( fino a circa 47 mesi) - Fino a Visita di fine studio ( fino a circa 47 mesi) - Fino a crica 48 mesi |
|
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 | 10 |
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 | Information not present in EudraCT |
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 |
Australia |
China |
Hong Kong |
India |
Israel |
Japan |
Korea, Republic of |
Malaysia |
Mexico |
Russian Federation |
Taiwan |
United States |
Bulgaria |
Denmark |
Italy |
Spain |
Czechia |
Argentina |
Greece |
|
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
|
|
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 | 3 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |