Clinical Trials Register

Summary
EudraCT Number:	2017-000656-26
Sponsor's Protocol Code Number:	BAY1142524/18933
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-10-05
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

Sweden - MPA

A.2

EudraCT number

2017-000656-26

A.3

Full title of the trial

A randomized, double-blind, multicenter study to assess the efficacy and safety of a 6 month
oral treatment with the chymase inhibitor BAY 1142524 at a dose of 25 mg BID in comparison
to placebo on top of standard of care in patients with type II diabetes and a clinical diagnosis of
diabetic kidney disease

En randomiserad, dubbelblind, multicenterstudie för att utvärdera effekt och säkerhet av en 6 månaders oral behandling med kymashämmaren BAY 1142524, vid en dos på 25 mg två gånger dagligen jämfört med placebo, i tillägg till standardbehandling hos patienter med diabetes typ II och en klinisk diagnos på diabetesrelaterad njursjukdom

A.3.1

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

Chymase inhibitor BAY 1142524 in patients with type II diabetes and a clinical diagnosis of diabetic kidney disease

Kymashämmare BAY 1142524 hos patienter med typ II-diabetes och en klinisk diagnos på diabetesrelaterad njursjukdom

A.4.1

Sponsor's protocol code number

BAY1142524/18933

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 Trails 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	+49303001390
B.5.5	Fax number	n.a.n.a.n.a.n.a.
B.5.6	E-mail	clinical-trails-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 1142524 25 mg Tablets
D.3.2	Product code	BAY 1142524 25 mg Tablets
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	not assigned
D.3.9.1	CAS number	not assigned
D.3.9.2	Current sponsor code	BAY 1142524
D.3.9.3	Other descriptive name	BAY 1142524
D.3.9.4	EV Substance Code	SUB126182
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	25
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 diabetic mellitus (T2DM) patients with a clinical diagnosis of diabetic kidney disease (CKD)

Patienter med typ II-diabetes och en klinisk diagnos på diabetesrelaterad njursjukdom

E.1.1.1

Medical condition in easily understood language

type II diabetic patients with a diabetic kidney disease

Patienter med typ II-diabetes och diabetesrelaterad njursjukdom

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Investigate the change in UACR from baseline values obtained at Visit 1 to 6 months after treatment with BAY 1142524, in comparison to placebo, on top of standard of care therapy.

Undersöka förändringen i U-albumin/kreatininkvot (UACR) från baslinjevärden som erhållits vid besök 1 till 6 månader efter behandling med BAY 1142524, jämfört med placebo, i tillägg till standardbehandling

E.2.2

Secondary objectives of the trial

Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events

Det sekundära målet med denna studie är att utvärdera säkerhet och tolerabilitet genom utvärdering av antalet och procentandelen patienter med behandlingsrelaterade biverkningar.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients with T2DM and a clinical diagnosis of DKD (as judged
by the investigator) who have finished their up-titration with an ARB or ACEI to
their maximum tolerated dose at least 3 months prior to the screening
visit, whereby the maximum tolerated dose has to be at least as high as
the minimal recommended dose of an ARB or ACEI according to local
and/or international guidelines. Patients have to be treated with an ARB
or ACEI, but not with both simultaneously, without any adjustments to
this therapy for at least 4 weeks prior to the screening visit.
2. UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive
morning void samples at the screening and the baseline visit
3. eGFR ≥30 mL/min/1.73 m2 and <90 mL/min/1.73 m2 (Chronic
Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the
screening visit and the baseline visit

E.4

Principal exclusion criteria

1. Non-DKD if it is the main diagnosis contributory to chronic
kidney disease (CKD), as judged by the investigator
2. Known bilateral clinical relevant renal artery stenosis (>75%)
3. New York Heart Association (NYHA) Class IV
4. Acute kidney injury or dialysis within the last 3 months before the
screening visit
5. Renal replacement therapy during study conduct
6. Renal allograft in place or a scheduled kidney transplant during
study conduct
7. Stroke, transient ischemic cerebral attack, acute coronary syndrome,
or hospitalization for heart failure in the last 3 months prior to screening
visit
8. Clinically relevant hepatic dysfunction
9. Uncontrolled hypertension as evidenced by systolic blood pressure
>160mmHg, diastolic blood pressure >100 mmHg (mean of triplicate
values at the screening or baseline visit after at least 10 minutes rest in
sitting position)

1.Icke-DKD om detta är den huvudsakliga diagnosen som bidrar till kronisk njursjukdom (CKD), enligt prövarens bedömning
2.Känd, bilateral, kliniskt relevant njurartärstenos (> 75 %)
3.NYHA (New York Heart Association) klass IV
4.Akut njurskada eller dialys inom de senaste 3 månaderna före screeningbesöket
5.Dialysbehandling under studiens gång
6.Njurtransplantat på plats eller en schemalagd njurtransplantation under studiens gång
7.Stroke, transitoriska ischemisk cerebral attack, akut koronarsyndrom eller sjukhusinläggning för hjärtsvikt under de senaste 3 månaderna före screeningbesöket
8.Kliniskt relevant leverdysfunktion
9.Okontrollerad hypertoni, vilket framgår av systoliskt blodtryck > 160 mmHg, diastoliskt blodtryck > 100 mmHg (medelvärde av tre värden i följd vid screening eller baslinjebesöket efter minst 10 minuters vila i sittande ställning)

E.5 End points

E.5.1

Primary end point(s)

Ratio of UACR at Visit 6 (167 ±14 days after Visit 1) to UACR at Visit 1

Förhållandet mellan UACR vid besök 6 (167 ±14 dagar efter besök 1) och UACR vid besök 1 (dag 0, innan behandling med studieläkemedlet påbörjas).

E.5.1.1

Timepoint(s) of evaluation of this end point

UACR will be assessed before the start of treatment with study drug (Visit 1) and after 6 months of treatment with study drug (Visit 6) for the primary variable.

UACR kommer att bedömas innan behandlingen med studieläkemedlet påbörjas (besök 1) och efter 6 månaders behandling med studieläkemedlet (besök 6) för den primära variabeln.

E.5.2

Secondary end point(s)

safety and tolerability

säkerhet och tolerabilitet

E.5.2.1

Timepoint(s) of evaluation of this end point

LVLS

Sista besöket för sita patienten

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

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

Yes

E.6.13.1

Other scope of the trial description

Biomarker and Tolerability

Biomarkörer och tolerabilitet

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

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

Bulgaria

Denmark

Finland

Israel

Italy

Spain

Sweden

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

Sista besöket för sista patienten

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

104

F.4.2.2

In the whole clinical trial

138

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

Ingen

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

2017-11-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-11-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-10-10

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