Clinical Trials Register

Summary
EudraCT Number:	2021-000421-27
Sponsor's Protocol Code Number:	21177
National Competent Authority:	Portugal - INFARMED
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2022-06-02
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

Portugal - INFARMED

A.2

EudraCT number

2021-000421-27

A.3

Full title of the trial

A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of FInerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease

Ensaio de fase 3 aleatorizado, em dupla ocultação, controlado por placebo, de grupos paralelos e multicêntrico para investigar a eficácia e a segurança da finerenona, adicionada ao padrão de tratamento, sobre a progressão da doença renal em doentes com doença renal crónica não associada à diabetes

A.3.1

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

A trial to learn how well finerenone works and how safe it is in adult participants with non-diabetic chronic kidney disease

Um ensaio para saber como funciona e quão segura é a finerenona em participantes adultos com doença renal crónica não associada à diabetes.

A.3.2

Name or abbreviated title of the trial where available

FIND-CKD

A.4.1

Sponsor's protocol code number

21177

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	N/A
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	13342
B.5.3.4	Country	Germany
B.5.4	Telephone number	004930300139003
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	BAY94-8862 10mg
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	BAY94-8862
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	BAY94-8862 20mg
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	BAY94-8862
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.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
D.8 Placebo: 2
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

Non-diabetic chronic kidney disease

Doença renal crónica não associada à diabetes

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

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

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.

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

E.2.3

Trial contains a sub-study

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

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)

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.

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

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

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

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

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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)

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

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

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

Última Consulta do Último Participante

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:

1106

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

474

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

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

381

F.4.2.2

In the whole clinical trial

1580

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

Nenhum

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

2022-06-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-06-03

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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