Clinical Trials Register

Summary
EudraCT Number:	2021-003037-11
Sponsor's Protocol Code Number:	21839
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:	2022-02-11
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2021-003037-11

A.3

Full title of the trial

A parallel-group treatment, Phase 2, double-blind, three-arm study to assess efficacy and safety of finerenone plus empagliflozin compared with either finerenone or empagliflozin in participants with chronic kidney disease and type 2 diabetes.

Estudio en fase II, de grupos paralelos, doble ciego y con tres grupos de tratamiento, para evaluar la eficacia y la seguridad de finerenona más empagliflozina en comparación con finerenona o empagliflozina en participantes con enfermedad renal crónica y diabetes tipo 2.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study to learn how well the treatment combination of finerenone and empagliflozin works and how safe it is compared to each treatment alone in adult participants with long-term kidney disease (chronic kidney disease) and type 2 diabetes

Un estudio para conocer la eficacia de la combinación de tratamiento de finerenona y empagliflozina y su seguridad en comparación con cada tratamiento por separado en participantes adultos con enfermedad renal de larga duración (enfermedad renal crónica) y diabetes de tipo 2

A.3.2

Name or abbreviated title of the trial where available

CONFIDENCE

A.4.1

Sponsor's protocol code number

21839

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Bayer AG
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bayer AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bayer AG
B.5.2	Functional name of contact point	Bayer Clinical Trials Contact
B.5.3	Address:
B.5.3.1	Street Address	Müllerstraße 178
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	13353
B.5.3.4	Country	Germany
B.5.6	E-mail	clinical-trials-contact@bayer.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Finerenone
D.3.2	Product code	BAY 94-8862 IR tablet 10 mg
D.3.4	Pharmaceutical form	Coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Finerenone
D.3.9.1	CAS number	1050477-31-0
D.3.9.2	Current sponsor code	BAY 94-8862
D.3.9.4	EV Substance Code	SUB183743
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Finerenone
D.3.2	Product code	BAY 94-8862 IR tablet 20 mg
D.3.4	Pharmaceutical form	Coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Finerenone
D.3.9.1	CAS number	1050477-31-0
D.3.9.2	Current sponsor code	BAY 94-8862
D.3.9.4	EV Substance Code	SUB183743
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Empagliflozin coated tablet 10 mg (Jardiance)
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Empagliflozin
D.3.2	Product code	BI 10773
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Empagliflozin
D.3.9.1	CAS number	864070-44-0
D.3.9.2	Current sponsor code	BI 10773
D.3.9.4	EV Substance Code	SUB35915
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic kidney disease in type 2 diabetes mellitus

Enfermedad renal crónica en diabetes mellitus de tipo 2

E.1.1.1

Medical condition in easily understood language

Chronic kidney disease, a long-term progressive decrease in the kidneys' ability to work properly, and type 2 diabetes, a condition characterized by high blood sugar levels

Enfermedad renal crónica,disminución progresiva a largo plazo de la capacidad de los riñones para funcionar correctamente;diabetes tipo 2,enfermedad caracterizada por altos niveles de azúcar en sangre

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10045250
E.1.2	Term	Type II diabetes mellitus with renal manifestations
E.1.2	System Organ Class	100000004857

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to demonstrate that combination therapy using finerenone and empagliflozin is superior in reducing UACR than either empagliflozin or finerenone alone

El objetivo principal es demostrar que el tratamiento combinado con finerenona y empagliflozina es mejor en cuanto a la reducción del CACo que la empagliflozina o la finerenona solas

E.2.2

Secondary objectives of the trial

The secondary outcomes are:
- To further investigate the efficacy of combination therapy using finerenone and empagliflozin versus either finerenone or empagliflozin alone.
- To evaluate the safety of combination therapy using finerenone and empagliflozin versus either finerenone or empagliflozin alone.

Los objetivos secundarios son:
- Investigar más a fondo la eficacia del tratamiento combinado con finerenona y empagliflozina frente a finerenona o empagliflozina solas.
- Evaluar la seguridad del tratamiento combinado con finerenona y empagliflozina frente a finerenona o empagliflozina solas.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Participant with a clinical diagnosis of chronic kidney disease (CKD)
and the following:
a. In Part A: eGFR 40-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnosis of CKD.
b. In Part B: eGFR 30-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using CKD-EPI formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnostic of CKD.
c. 300 ≤UACR <5000 mg/g at screening visit (mean value from 3 morning void samples) and documentation of albuminuria/proteinuria (quantitative or semi-quantitative measurement) in the participant's medical records at least 3 months prior to screening.
2. Participant with type 2 diabetes (T2D) as defined by the American Diabetes Association (ADA 2021), with glycated hemoglobin (HbA1c) at screening <11%.
3. Participant treated with the clinically maximum tolerated dose, as per investigator judgment, of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), but not both, for more than 1 month at screening visit.

Please refer to the protocol for a full list of inclusion criteria

1.Participante con diagnóstico clínico de ERC y lo siguiente:
a.En la parte A: TFGe 40-90 ml/min/1,73 m2 (con un valor máximo del 20 % en la TFGe >75 ml/min/1,73 m2) utilizando la fórmula de colaboración de epidemiología de insuficiencia renal crónica (Chronic Kidney Disease Epidemiology Collaboration, CKD-EPI) en la visita de selección y al menos un valor histórico de TFGe <60 ml/min/1,73 m2 en el plazo de 3 meses o tener un diagnóstico registrado de ERC.
b.En la parte B: TFGe 30-90 ml/min/1,73 m2 (con un valor máximo del 20 % en la TFGe >75 ml/min/1,73 m2) utilizando la fórmula CKD-EPI en la visita de selección y al menos un valor histórico de TFGe <60
ml/min/1,73 m2 en el plazo de 3 meses o tener un diagnóstico registrado de ERC.
c.300 ≤UACR <5000 mg/g en la visita de selección (valor medio de 3 muestras de micción matutinas) y documentación de albuminuria/proteinuria (medición cuantitativa o semicuantitativa) en la historia clínica del participante al menos 3 meses antes de la selección.
2.Participante con DT2 definida por la ADA, con hemoglobina glicada (HbA1c) en la selección <11 %. Nota: Los valores históricos de HbA1c serán aceptables para la inclusión siempre que se hayan obtenido en los 3 meses anteriores a la visita de selección.
3.Participante tratado con la dosis máxima tolerable clínicamente, según el criterio del investigador, de IECA o BRA, pero no ambos, durante más de 1 mes en la visita de selección.

Para más información consultar la lista completa de los criterios de inclusión

E.4

Principal exclusion criteria

1. Participants with type 1 diabetes (T1D).
2. Participant with hepatic insufficiency classified as Child-Pugh C.
3. Participant with blood pressure at Day 1 visit higher than 160/100 or systolic blood pressure lower than 90 mmHg.
4. Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
5. Participant treated with another mineralocorticoid receptor antagonist (MRA) (e.g., eplerenone, esaxerenone, spironolactone, canrenone), a renin inhibitor, potassium supplements, a potassium sparing diuretic (e.g., amiloride, triamterene), a potassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
6. Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit.
7. Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening.

Please refer to the protocol for a full list of exclusion criteria

1.Participantes con diabetes tipo 1 (DT1).
2.Participante con insuficiencia hepática clasificada como Child-Pugh C.
3.Participante con PA en la visita del día 1 superior a 160/100 o PAS inferior a 90 mm Hg.
4.Participante tratado actualmente con un SGLT2i o un inhibidor combinado de SGLT-1 y 2 (SGLT-1/2i) o que recibió un SGLT2i o un SGLT-1/2i que no se puede interrumpir al menos 8 semanas antes de la
visita de selección y durante el tratamiento de intervención del estudio.
5.Participante tratado con otro ARM (p. ej., eplerenona, esaxerenona, espironolactona, canrenona), un inhibidor de la renina, suplementos de K+, un diurético ahorrador de K+ (p. ej., amilorida, triamtereno), un quelante de K+ o un inhibidor del receptor de angiotensina-neprilisina (IRAN) en las 8 semanas anteriores a la visita de selección y durante el tratamiento.
6.Participantes tratados actualmente o que fueron tratados con finerenona (Kerendia®) en las 8 semanas anteriores a la visita de selección.
7.Participante con K+ superior a 4,8 mmol/l en la visita de selección.

Para más información consultar la lista completa de los criterios de exclusión

E.5 End points

E.5.1

Primary end point(s)

1. Mean ratio of change from baseline to Day 180 in Urinary albumin tocreatinine ratio (UACR) for the combination therapy group, to empagliflozin alone
2. Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alone.

1.Cociente medio del cambio desde el inicio hasta el día 180 en el CACo para el grupo de tratamiento combinado, en comparación con la empagliflozina sola
2.Cociente medio del cambio desde el inicio hasta el día 180 en el CACo para el grupo de tratamiento combinado, en comparación con la finerenona sola

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to 180 Days

Hasta 180 días

E.5.2

Secondary end point(s)

1.Relative change in UACR between end of treatment visit and 30 days after end of treatment visit
2.Relative change in UACR between 30 days after end of treatment visit and baseline
3.Relative change in UACR category (>30%, >40%, >50%) at 180 days
4.Ratio of change from baseline in eGFR at 30 days
5.eGFR decline greater than 30% at 30 days from baseline
6.Ratio of change in eGFR at 180 days and 210 days from day 30
7.Number of participants with of AKI events
8.Total number of AKI events
9.Number of participants with hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mol/L], severe hyperkalemia [K+ >6.0 mmol/L])
10.Total number of hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])

Please refer to the protocol for a full list of secondary end points

1.Cambio relativo en el CACo entre la visita de final del tratamiento y 30 días después de la visita de final del tratamiento
2.Cambio relativo en el CACo entre 30 días después de la visita de final del tratamiento y el inicio
3.Cambio relativo en la categoría del CACo (>30 %, >40 %, >50 %) a los 180 días
4.Cociente del cambio desde el inicio en la TFGe a los 30 días
5.Disminución de la TFGe superior al 30 % a los 30 días con respecto al inicio
6.Cociente del cambio en la TFGe a los 180 días y a los 210 días desde el día 30
7.Número de participantes con acontecimientos de LRA
8.Número total de acontecimientos de LRA
9.Número de participantes con acontecimientos de hiperpotasemia (hiperpotasemia moderada [5,5 <K+ ≤6,0 mmol/l], hiperpotasemia grave [K+ >6,0 mmol/l])
10.Número total de acontecimientos de hiperpotasemia (hiperpotasemia moderada [5,5 <K+ ≤6,0 mmol/l], hiperpotasemia grave [K+ >6,0 mmol/l])

Para más información consultar la lista completa de los criterios de valoración secundarios

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Up to 210 days
2. Up to 210 days
3. Up to 180 days
4. Up t0 30 days
5. Up to 30 days
6. Up to 210 days
7. to 23. Up to 180 days

1. Hasta 210 días
2. Hasta 210 días
3. Hasta 180 días
4. Hasta 30 días
5. Hasta 30 días
6. Hasta 210 días
7. Desde 23 hasta 180 días

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

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

Belgium

Canada

Denmark

France

Germany

Israel

Italy

Japan

Korea, Republic of

Netherlands

Spain

Taiwan

United States

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

LVLS

UPUV

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

600

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

207

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Subjects who can not consent themselves, but with a legal guardian

Sujetos que no pueden dar su consentimiento por sí mismos, sino con un tutor legal

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

318

F.4.2.2

In the whole clinical trial

807

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)

NONE

NINGUNO

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-04-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-04-04

P. End of Trial
P.	End of Trial Status	Ongoing

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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