Clinical Trials Register

Summary
EudraCT Number:	2015-000950-39
Sponsor's Protocol Code Number:	BAY94-8862/17530
National Competent Authority:	Ireland - HPRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-08-08
Trial results	View 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

Ireland - HPRA

A.2

EudraCT number

2015-000950-39

A.3

Full title of the trial

A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study to investigate the efficacy and safety of finerenone on the reduction of cardiovascular morbidity and mortality in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease in addition to standard of care.

A.3.1

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

Efficacy and safety of finerenone in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease

A.3.2

Name or abbreviated title of the trial where available

FIGARO-DKD

A.4.1

Sponsor's protocol code number

BAY94-8862/17530

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	-
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	4930300139003
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	BAY 94-8862 IR tablet 10 mg
D.3.2	Product code	BAY 94-8862 coated tablet 10 mg
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	Finerenone
D.3.9.1	CAS number	1050477-31-0
D.3.9.2	Current sponsor code	BAY 94-8862 micronized
D.3.9.3	Other descriptive name	BAY 94-8862
D.3.9.4	EV Substance Code	SUB30924
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	BAY 94-8862 IR tablet 20 mg
D.3.2	Product code	BAY 94-8862 coated tablet 20 mg
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	Finerenone
D.3.9.1	CAS number	1050477-31-0
D.3.9.2	Current sponsor code	BAY 94-8862 micronized
D.3.9.3	Other descriptive name	BAY 94-8862
D.3.9.4	EV Substance Code	SUB30924
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	Film-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

Type II Diabetes Mellitus and Diabetic Kidney Disease

E.1.1.1

Medical condition in easily understood language

Type II Diabetes Mellitus and Diabetic Kidney Disease

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10061835
E.1.2	Term	Diabetic nephropathy
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

Demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the time to first occurrence of cardiovascular mortality and morbidity in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease.

E.2.2

Secondary objectives of the trial

•Delays the time to first occurrence of the following composite endpoint: onset of kidney failure, a sustained decrease in estimated glomerular filtration rate (eGFR) of ≥40% from baseline over at least 4 weeks or renal death
•Delays the time to all-cause hospitalization
•Delays the time to all-cause mortality
•Change in UACR from baseline to Month 4
•Delays the time to first occurrence of the following composite endpoint:
onset of kidney failure, a sustained decrease in eGFR of ≥57% from baseline over at least 4 weeks or renal death.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Echocardiography sub-study (section 9.7.8.1.1 of the CSP): The objective of the echocardiography imaging sub-study is to assess and characterize any important structural and functional cardiac abnormalities in patients with type 2 diabetes mellitus and diabetic kidney disease, at baseline, and to explore changes over time with finerenone treatment. These findings will enhance the understanding of cardiac function in the diabetic kidney disease Population
Biomarker sub-study (section 9.7.8.1.2 of the CSP): The objective of the biomarker sub-study is to assess the levels of pathophysiological markers associated with cardiovascular and renal disease in patients with type 2 diabetes mellitus and diabetic kidney disease, at baseline, and to explore changes over time with finerenone treatment. These findings will enhance the understanding of the effects of finerenone on cardiovascular and renal disease progression, by evaluating these biological markers in addition to clinical outcomes

E.3

Principal inclusion criteria

- Men or women aged 18 years and older. The lower age limit may be higher if legally required in the participating country.
- Women of childbearing potential can only be included in the study if a pregnancy test is negative at the screening visit and if they agree to use adequate contraception. Adequate contraception is defined as any combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices). Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate) or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL [for US only: FSH levels > 40 mIU/mL and estradiol < 20 pg/mL] or have had surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy.
-Subjects with type 2 diabetes mellitus as defined by the American Diabetes Association
-Subjects with a clinical diagnosis of DKD based on either of the following criteria at the Run-in and Screening Visit:
Persistent high albuminuria defined as UACR of ≥ 30 mg/g (≥ 3.4 mg/mmol) but < 300 mg/g (< 33.9 mg/mmol) in 2 out of 3 first morning void samples and eGFR ≥ 25 but ≤ 90 mL/min/1.73 m2 (CKD-EPI)
OR
Persistent very high albuminuria defined as UACR of ≥300 mg/g (≥33.9 mg/mmol) in 2 out of 3 first morning void samples and eGFR ≥60 mL/min/1.73 m2 (CKD-EPI)
-Prior treatment with ACEIs and ARBs as follows:
For at least 4 weeks prior to the Run-in Visit, subjects should be treated with either an ACEI or ARB, or both
Starting with the Run-in Visit, subjects should be treated with only an ACEI or ARB
For at least 4 weeks prior to the Screening Visit, subjects should be treated with the maximum tolerated labeled dose (but not below the minimal labeled dose) of only an ACEI or an ARB (not both) preferably without any adjustments to dose or choice of agent or to any other antihypertensive or antiglycemic treatment
- Serum potassium ≤ 4.8 mmol/L at both the Run-in and the Screening Visit

E.4

Principal exclusion criteria

- Known significant non-diabetic renal disease, including clinically relevant renal artery stenosis
- Uncontrolled arterial hypertension with mean sitting systolic blood pressure (SBP) ≥ 170 mmHg or mean sitting diastolic blood pressure (DBP) ≥ 110 mmHg at the Run-in Visit or mean sitting SBP ≥160 mmHg or mean sitting DBP ≥100 mmHg at the Screening Visit
- Clinical diagnosis of chronic HFrEF and persistent symptoms (NYHA class II – IV) at Run in visit (class 1A recommendation for MRAs)
- Dialysis for acute renal failure within 12 weeks of Run-in visit
- Renal allograft in place or scheduled kidney transplant within next 12 months from the Run-in visit
- HbA1c > 12% (> 108 mmol/mol) at the Run-in Visit or Screening Visit

E.5 End points

E.5.1

Primary end point(s)

Time to first occurrence of the composite endpoint of CV death or non-fatal CV event (i.e. myocardial infarction, stroke, or hospitalization for HF).

E.5.1.1

Timepoint(s) of evaluation of this end point

From randomization (Visit 1) until the end of study following the study termination decision, approximately from 7 to 51 months

E.5.2

Secondary end point(s)

Time to first occurrence of the following composite endpoint:
onset of kidney failure, a sustained decrease of eGFR ≥ 40% from baseline over at least 4 weeks or renal death
Time to all-cause hospitalization
Time to all-cause mortality
Change in UACR from baseline to Month 4
Time to first occurrence of the following composite endpoint: onset of kidney failure, a sustained decrease in eGFR of ≥ 57% from baseline over at least 4 weeks or renal death.

E.5.2.1

Timepoint(s) of evaluation of this end point

For all endpoints:
From randomization (Visit 1) until the end of study following the study termination decision, approximately from 18 to 36 months

Except endpoint*:
Frombaseline / randomization to Month 4

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)

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

300

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

Austria

Belgium

Brazil

Bulgaria

Canada

Chile

China

Colombia

Czech Republic

Denmark

Finland

France

Germany

Greece

Hong Kong

Hungary

Ireland

Israel

Italy

Japan

Korea, Republic of

Lithuania

Malaysia

Mexico

Netherlands

New Zealand

Norway

Philippines

Poland

Portugal

Romania

Russian Federation

Singapore

Slovakia

South Africa

Spain

Sweden

Switzerland

Taiwan

Thailand

Turkey

Ukraine

United Kingdom

United States

Vietnam

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

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:

7630

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

5170

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

Patients unable to sign can be consented by legally acceptable representative/guardian/parent

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

6000

F.4.2.2

In the whole clinical trial

12800

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)

Standard treatment

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

2016-10-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-10-17

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-02-02

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