Clinical Trials Register

Summary
EudraCT Number:	2017-000656-26
Sponsor's Protocol Code Number:	BAY1142524/18933
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-01-07
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

Italy - Italian Medicines Agency

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

Studio multicentrico, randomizzato, in doppio cieco volto a valutare l¿efficacia e la sicurezza di un trattamento semestrale a base dell¿inibitore della chimasi BAY 1142524 somministrato per os alla dose di 25 mg due volte al giorno rispetto al placebo come aggiunta allo standard di cura in pazienti affetti da diabete di tipo II e con diagnosi clinica di nefropatia diabetica

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

Inibitore della chimasi BAY 1142524 somministrato in pazienti affetti da diabete tipo II e con diagnosi clinica di nefropatia diabetica

A.3.2

Name or abbreviated title of the trial where available

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

Inibitore della chimasi BAY 1142524 somministrato in pazienti affetti da diabete di tipo II e con di

A.4.1

Sponsor's protocol code number

BAY1142524/18933

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN00000000

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00000000

A.5.3

WHO Universal Trial Reference Number (UTRN)

U0000-0000-0000

A.5.4

Other Identifiers

Name:

Number:

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	non disponibile
B.5.3.2	Town/ city	Berlino
B.5.3.3	Post code	13342
B.5.3.4	Country	Germany
B.5.4	Telephone number	0049303001390
B.5.5	Fax number	non disponibile
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.3.9.2	Current sponsor code	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)

Diabete mellito di tipo II (Type II Diabetes Mellitus, T2DM) con diagnosi clinica di nefropatia diabetica (Diabetic Kidney Disease, DKD)

E.1.1.1

Medical condition in easily understood language

type II diabetic patients with a diabetic kidney disease

pazienti affetti da diabete di tipo II e con diagnosi clinica di nefropatia diabetica

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	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

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.

Valutare la variazione del rapporto urinario albumina-creatinina (Urinary Albumin-To-Creatinine Ratio, UACR) dai valori basali ottenuti alla Visita 1 rispetto a 6 mesi dopo il trattamento con BAY 1142524 in comparazione con il placebo, come aggiunta alla terapia standard di cura.

E.2.2

Secondary objectives of the trial

assess safety and tolerability as evidenced by the incidence and severity of adverse events

valutare la sicurezza e la tollerabilit¿ come provato dalla frequenza e dalla gravit¿ degli eventi avversi.

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) treated with at least the minimal recommended dose of an ARB or an ACEI (according to international or local guidelines) – but not with both simultaneously – for at least 3 months prior to the screening visit 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

1. Pazienti affetti da T2DM e con diagnosi clinica di DKD (in base al parere dello sperimentatore)trattati con un ARB o un ACEI ad almeno la dose minima raccomandata (secondo le linee guida internazionali o locali), ma non con entrambi contemporaneamente, per almeno 3 mesi prima della Visita di screening senza alcuna modifica alla terapia per almeno 4 settimane prima di tale visita
2. UACR >50 mg/g e <3.000 mg/g riscontrato in almeno 2 di 3 campioni consecutivi di urine della minzione del mattino alla Visita di screening e alla Visita basale
3. eGFR =30 ml/min/1,73 m2 e <90 ml/min/1,73 m2 (secondo la formula del Chronic Kidney Disease Epidemiology Collaboration [CKD EPI]) alla Visita di screening e alla Visita basale

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
>180 mmHg, diastolic blood pressure >110 mmHg (mean of triplicate values at the screening or baseline visit after at least 10 minutes rest in sitting position

1. Assenza di DKD se si tratta della diagnosi principale che concorre alla nefropatia cronica (Chronic Kidney Disease, CKD), in base al parere dello sperimentatore
2. Stenosi bilaterale dell’arteria renale nota e significativa dal punto di vista clinico (>75%)
3. Insufficienza cardiaca di classe IV secondo la New York Heart Association (NYHA)
4. Danno renale acuto o dialisi entro gli ultimi 3 mesi prima della Visita di screening
5. Terapia renale sostitutiva durante la conduzione dello studio
6. Allotrapianto renale eseguito o trapianto renale programmato durante la conduzione dello studio
7. Ictus, attacco ischemico cerebrale transitorio, sindrome coronarica acuta o ricovero ospedaliero per insufficienza cardiaca negli ultimi 3 mesi prima della Visita di screening
8. Disfunzione epatica clinicamente rilevante
9. Ipertensione non controllata, come evidenziato da pressione arteriosa sistolica >180 mmHg, pressione arteriosa diastolica >110 mmHg (media dei valori in triplicato alla Visita di screening o basale dopo almeno 10 minuti a riposo in posizione seduta)

E.5 End points

E.5.1

Primary end point(s)

The primary variable will be the ratio of UACR at Visit 6 (167 ±14 days after Visit 1) to UACR at Visit 1 (Day 0, before start of treatment with study drug).

La variabile primaria sarà il rapporto tra l’UACR alla Visita 6 (167 ±14 giorni dopo la Visita 1) e l’UACR alla Visita 1 (Giorno 0, prima dell’inizio del trattamento con il farmaco in studio).

E.5.1.1

Timepoint(s) of evaluation of this end point

Per la variabile primaria, l’UACR verrà valutato prima dell’inizio del trattamento con il farmaco in studio (Visita 1) e dopo 6 mesi di trattamento con il farmaco in studio (Visita 6).

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.

E.5.2

Secondary end point(s)

safety and tolerability

sicurezza e tollerabilit¿

E.5.2.1

Timepoint(s) of evaluation of this end point

LVLS

Ultima Visita dell'Ultimo Soggetto (Last Visit of the Last Subject, LVLS)

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

biomarcatori e tollerabilit¿

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

Information not present in EudraCT

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

Israel

Bulgaria

Denmark

Finland

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

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

F.4.2.2

In the whole clinical trial

107

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

nessuno

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

2017-12-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-01-11

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
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