Страница клинических исследований Nct

Summary
EudraCT Number:2021-002905-89
Sponsor's Protocol Code Number:20186
National Competent Authority:Spain - AEMPS
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2022-07-27
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2021-002905-89
A.3Full title of the trial
An 18-month, open-label, single-arm safety extension study of an age-and bodyweight-adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children and young adults from 1 to 18 years of age with chronic kidney disease and proteinuria
Ensayo de extensión de seguridad de 18 meses, abierto y de un solo brazo, de un régimen de finerenona oral, ajustado por edad y peso corporal, añadido a un IECA o ARA II para el tratamiento de pacientes pediátricos y adultos jóvenes de 1 a 18 años con enfermedad renal crónica y proteinuria.
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
FInerenone for the treatment of children with chrOnic kidNey disease and proteinuriA – Open-Label safety Extension
Finerenona para el tratamiento de pacientes pediátricos con enfermedad renal crónica y proteinuria - Extensión de seguridad abierta.
A.3.2Name or abbreviated title of the trial where available
FIONA OLE
A.4.1Sponsor's protocol code number20186
A.7Trial is part of a Paediatric Investigation Plan Yes
A.8EMA Decision number of Paediatric Investigation PlanP/298/2021
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorBayer AG
B.1.3.4CountryGermany
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportBayer AG
B.4.2CountryGermany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationBayer AG
B.5.2Functional name of contact pointBayer Clinical Trials Contact
B.5.3 Address:
B.5.3.1Street AddressN/A
B.5.3.2Town/ cityBerlin
B.5.3.3Post code13342
B.5.3.4CountryGermany
B.5.4Telephone number0049303001139003
B.5.6E-mailclinical-trials-contact@bayer.com
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameFinerenone
D.3.2Product code BAY 94-8862 10 mg
D.3.4Pharmaceutical form Coated tablet
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNFinerenone
D.3.9.1CAS number 1050477-31-0
D.3.9.2Current sponsor codeBAY 94-8862
D.3.9.4EV Substance CodeSUB183743
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number10
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameFinerenone
D.3.2Product code BAY 94-8862 20 mg
D.3.4Pharmaceutical form Coated tablet
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNFinerenone
D.3.9.1CAS number 1050477-31-0
D.3.9.2Current sponsor codeBAY 94-8862
D.3.9.4EV Substance CodeSUB183743
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number20
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 3
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameFinerenone
D.3.2Product code BAY 94-8862 granules 3.4%
D.3.4Pharmaceutical form Granules for oral suspension
D.3.4.1Specific paediatric formulation Yes
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNFinerenone
D.3.9.1CAS number 1050477-31-0
D.3.9.2Current sponsor codeBAY 94-8862
D.3.9.4EV Substance CodeSUB183743
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number103.6
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Treatment of children with chronic kidney disease and proteinuria
Tratamiento de pacientes pediátricos con enfermedad renal crónica y proteinuria.
E.1.1.1Medical condition in easily understood language
Chronic kidney disease, which is long-term kidney disease, and proteinuria, a condition in which a person has extra protein in the urine
Enfermedad renal crónica, que es enfermedad renal a largo plazo, y proteinuria, una afección en la que una persona tiene proteína adicional en la orina.
E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 23.1
E.1.2Level PT
E.1.2Classification code 10064848
E.1.2Term Chronic kidney disease
E.1.2System Organ Class 10038359 - Renal and urinary disorders
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.1
E.1.2Level PT
E.1.2Classification code 10037032
E.1.2Term Proteinuria
E.1.2System Organ Class 10038359 - Renal and urinary disorders
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
The main objective is to demonstrate that finerenone in addition to an ACEI or ARB is safe when given long-term.
Demostrar que la finerenona, añadida a un inhibidor de la enzima convertidora de la angiotensina (IECA) o un antagonista de los receptores de la angiotensina (ARA II), es segura cuando se administra a largo plazo.
E.2.2Secondary objectives of the trial
The secondary objective is to assess the long-term treatment effects on proteinuria and kidney function of finerenone in addition to standard of care.
Evaluar los efectos del tratamiento a largo plazo con finerenona añadida al tratamiento de referencia (TdR) sobre la proteinuria y la función renal.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
1. Participants must be ≥1 year to 18 years of age, at the time of signing the informed consent/assent.
2. Prior participation in the finerenone Phase 3 study FIONA (19920) and not permanently discontinued from treatment by the end of treatment (EoT) visit in FIONA.
3. Participants must have a clinical diagnosis of chronic kidney disease (CKD) at Visit 1 which is defined as
- CKD stages 1-3 (estimated glomerular filtration rate [eGFR] ≥30 mL/min/1.73m^2) for children ≥1 year to <19 years of age at FIONA EoT and at Visit 1
4. Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure (BP) management, unchanged for at least 30 days prior to Visit 1.
5. K+ ≤5.0 mmol/L for children ≥2 years of age at both FIONA EoT and Visit 1, and ≤5.3 mmol/L for children <2 years of age at both FIONA EoT and Visit 1
6. Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding.
1. Los participantes deben tener de ≥1 año a 18 años de edad en el momento de firmar el consentimiento informado/asentimiento.
2. Participación previa en el ensayo de fase III de finerenona FIONA (19920) y no haber interrumpido permanentemente el tratamiento en la visita de FdT en FIONA.
3. Los participantes deben tener un diagnóstico clínico de ERC en la visita 1, que se define como:
• ERC en estadios 1-3 (FGe ≥30 ml/min/1,73 m2) en participantes de ≥1 año a <19 años de edad al FdT en FIONA y en la visita 1.
4. Tratamiento con un IECA o ARA II en dosis optimizadas definidas como dosis máximas tolerables dentro del intervalo de dosis recomendado de acuerdo con las directrices sobre el control de la PA, sin cambios durante al menos 30 días antes de la visita 1.
5. K+ ≤5,0 mmol/l en pacientes pediátricos ≥2 años de edad tanto al FdT en FIONA como en la visita 1, y ≤5,3 mmol/l en pacientes pediátricos <2 años de edad tanto al FdT en FIONA como en la visita 1.
6. El participante puede recibir alimentación enteral (alimentos sólidos, alimentación con biberón o taza, alimentación a través de sondas nasogástricas o gástricas) con o sin lactancia materna.
E.4Principal exclusion criteria
1. Planned urological surgery expected to influence renal function
2. Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
3. Systemic hypertension Stage 2 defined according to institutional guidelines on BP management at Visit 1.
4. Systemic hypotension defined as symptomatic hypotension or a mean systolic BP below the 5th percentile for age, sex and height but no lower than 80 mmHg for participants <18 years and symptomatic hypotension or a mean systolic blood pressure (SBP) <90 mmHg in participants ≥18 years at Visit 1.
5. Known hypersensitivity to the study treatment (active substance or excipients)
6. Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores.
7. Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids
8. Concomitant therapy with a mineralocorticoid receptor antagonist (MRA) (eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any sodium-glucose co-transporter-2 (SGLT2) inhibitor (SGLT2i), sacubitril/valsartan combination (ARNI), or potassium-sparing diuretic (amiloride, triamterene)
9. Concomitant therapy with both ACEI and ARBs together
10. Concomitant therapy with strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, moderate or strong CYP3A4 inducers
11. Previous assignment to treatment during this study
12. Simultaneous participation in another interventional clinical study (e.g., Phase 1 to 4 clinical studies).
13. Experienced a drug-related serious adverse event (SAE) or an adverse event (AE) which led to permanent discontinuation of study intervention during the FIONA study
14. Pregnant or breastfeeding or intention to become pregnant during the study
1. Cirugía urológica planificada que previsiblemente influirá en la función renal.
2. Pacientes que son candidatos para trasplante renal, es decir, un trasplante de riñón programado dentro del intervalo de tiempo del ensayo.
3. Hipertensión sistémica en estadio 2 definida según las guías del centro sobre el control de la PA en la visita 1.
4. Hipotensión sistémica definida como hipotensión sintomática o PA sistólica media por debajo del percentil 5 para la edad, el sexo y la estatura, pero no inferior a 80 mm Hg para participantes <18 años e hipotensión sintomática o PAS media <90 mm Hg en participantes ≥18 años en la visita 1.
5. Hipersensibilidad conocida al tratamiento del ensayo (principio activo o excipientes).
6. Insuficiencia hepática grave definida, por ejemplo, como Child-Pugh C o puntuaciones análogas.
7. Participantes que reciben rituximab, ciclofosfamida, abatacept o glucocorticoides intravenosos.
8. Tratamiento concomitante con un antagonista de los receptores de mineralocorticoides (ARM) (eplerenona, espironolactona, esaxerenona, canrenona), cualquier inhibidor de la renina (aliskireno, enalkireno, remikireno), cualquier inhibidor del cotransportador sodio glucosa 2(SGLT2i), la combinación sacubitrilo/valsartán (INRA) o un diurético ahorrador de potasio (amilorida, triamtereno).
9. Tratamiento concomitante con IECA y ARA II juntos.
10. Tratamiento concomitante con inhibidores potentes de la isoenzima CYP3A4, inductores moderados o potentes de la isoenzima CYP3A4.
11. Asignación previa al tratamiento durante este ensayo.
12. Participación simultánea en otro ensayo clínico de intervención (p. ej., ensayos clínicos de fase I a IV).
13. Haber experimentado un AA relacionado con el medicamento o un AA que condujera a la interrupción permanente de la intervención del ensayo durante el ensayo FIONA.
14. Embarazada o amamantando o intención de quedarse embarazada durante el ensayo.
E.5 End points
E.5.1Primary end point(s)
1. Number of participants with treatment emergent adverse events (TEAEs)
2. Change in serum potassium levels from baseline to Day 540±7
3. Change in systolic blood pressure (SBP) from baseline to Day 540±7
1. Número de participantes con acontecimientos adversos surgidos durante el tratamiento (AAST)
2. Variación en los niveles séricos de potasio desde la visita basal hasta el día 540 ± 7.
3.Variación en la presión arterial sistólica (PAS) desde la visita basal hasta el día 540 ± 7.
E.5.1.1Timepoint(s) of evaluation of this end point
Up to 547 days
Hasta 547 días
E.5.2Secondary end point(s)
1. Change in urinary protein-to-creatinine ratio (UPCR) and urinary albumin-to-creatinine ratio (UACR) from baseline to Day 540±7
2. Change in estimated glomerular filtration rate (eGFR) from baseline to Day 540±7
1. Variación en el cociente proteína/creatinina en orina (CPCO) y en el cociente albúmina/creatinina en orina (CACO) desde la visita basal hasta el día 540 ± 7.
2. Variación en la TFGe desde la visita basal hasta el día 540 ± 7.
E.5.2.1Timepoint(s) of evaluation of this end point
Up to 547 days
Hasta 547 días
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Yes
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled No
E.8.1.1Randomised No
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other No
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.8.4.1Number of sites anticipated in Member State concerned5
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA64
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
Australia
Canada
Israel
Korea, Republic of
United States
Austria
Finland
France
Lithuania
Poland
Sweden
Netherlands
Spain
Switzerland
Czechia
Germany
Greece
Italy
Belgium
Denmark
Hungary
Portugal
Turkey
United Kingdom
E.8.7Trial 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
The end of the study is defined as the date of the last visit of the last participant in the study globally.
El fin del estudio se define como la fecha de la última visita del último participante en el estudio a nivel mundial.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years5
E.8.9.1In the Member State concerned months5
E.8.9.1In the Member State concerned days10
E.8.9.2In all countries concerned by the trial years5
E.8.9.2In all countries concerned by the trial months5
E.8.9.2In all countries concerned by the trial days10
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Yes
F.1.1Number of subjects for this age range: 100
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) Yes
F.1.1.4.1Number of subjects for this age range: 10
F.1.1.5Children (2-11years) Yes
F.1.1.5.1Number of subjects for this age range: 40
F.1.1.6Adolescents (12-17 years) Yes
F.1.1.6.1Number of subjects for this age range: 40
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 10
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state9
F.4.2 For a multinational trial
F.4.2.1In the EEA 60
F.4.2.2In the whole clinical trial 100
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
After this open-label, single-arm safety extension study, continued access in a long-term study will be offered to participants until marketing authorization depending on country-specific requirements.
Después de este estudio abierto de extensión de seguridad de un solo brazo, se ofrecerá acceso continuo en un estudio a largo plazo a los participantes hasta la autorización de comercialización, dependiendo de los requisitos específicos del país.
G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1Name of Organisation Conect4children (c4c)
G.4.3.4Network Country United Kingdom
G.4 Investigator Network to be involved in the Trial: 2
G.4.1Name of Organisation North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS)
G.4.3.4Network Country United States
G.4 Investigator Network to be involved in the Trial: 3
G.4.1Name of Organisation ESCAPE
G.4.3.4Network Country Germany
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2022-10-06
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2022-09-19
P. End of Trial
P.End of Trial StatusOngoing

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