Long-term Pre-dialysis Extension in Europe and Asia Pacific

PHASE2CompletedINTERVENTIONAL
Enrollment

166

Participants

Timeline

Start Date

June 24, 2014

Primary Completion Date

November 15, 2016

Study Completion Date

December 12, 2016

Conditions
AnemiaRenal Insufficiency, Chronic
Interventions
DRUG

Molidustat (BAY85-3934)

BAY85-3934 will be titrated at the scheduled dose control visits to maintain the Hb in the target range of 10.0 to 12.0 g/dL. Available doses include 15, 25, 50, 75, 100, and 150 mg/day OD. Treatment will be for minimum of 6 months to up to a maximum of 36 months.

BIOLOGICAL

Darbepoetin

Darbepoetin will be administered according to the local label and titrated at the scheduled dose by intravenous injection. Treatment will be for a minimum of 6 months to up to a maximum of 36 months.

Trial Locations (105)

1036

Budapest

1309

Sofia

1431

Sofia

1527

Sofia

1872

Sofia

2250

Gosford

2500

Esztergom

3052

Melbourne

3073

Reservoir

3400

Montana

4032

Debrecen

4300

Karlovo

4400

Pazardzhik

5000

Veliko Tarnovo

5300

Gabrovo

5500

Lovech

6000

Stara Zagora

6500

Baja

7400

Kaposvár

7624

Pécs

7900

Szigetvár

8000

Burgas

9300

Dobrich

12053

Berlin

14004

Córdoba

15706

Santiago de Compostela

20132

Milan

20162

Milan

23900

Lecco

25123

Brescia

26100

Cremona

27100

Pavia

28007

Madrid

28041

Madrid

28702

San Sebastián de los Reyes

29609

Brest

38043

Grenoble

40210

Düsseldorf

41100

Modena

42283

Wuppertal

53127

Bonn

57023

Livorno

59300

Valenciennes

66013

Chieti

66953

Pirmasens

69495

Pierre-Bénite

78052

Villingen-Schwenningen

80138

Napoli

87042

Limoges Cedex1

410469

Oradea

500152

Brasov

540103

Târgu Mureş

900591

Constanța

2210001

Nahariya

3810101

Hadera

4428164

Kfar Saba

7827804

Ashkelon

9112001

Jerusalem

06097

Halle

802-8555

Kitakyushu

831-0016

Ōkawa

050-0083

Muroran

924-8588

Hakusan

020-0066

Morioka

251-8550

Fujisawa

247-8533

Kamakura

511-0061

Kuwana

260-8712

Chiba

810-8563

Fukuoka

388-8004

Nagano

631-0846

Nara

15-540

Bialystok

61-858

Poznan

26-610

Radom

70-111

Szczecin

96-300

Żyrardów

010731

Bucharest

020475

Bucharest

050098

Bucharest

420-767

Bucheon-si

03080

Seoul

156-707

Seoul

156-755

Seoul

08907

L'Hospitalet de Llobregat

03010

Alicante

08035

Barcelona

08036

Barcelona

06100

Ankara Univ. Medical Faculty, Ankara

06490

Baskent University Medical Faculty, Ankara

03540

Sifa University Medical Faculty, Izmir

RG2 0TG

Reading

CB2 0QQ

Cambridge

DD1 9SY

Dundee

BN2 5BE

Brighton

M5 5AP

Salford

NE46 1QJ

Hexham

DN2 5LT

Doncaster

WF3 4PX

Leeds

PR7 7NA

Chorley

G20 OSP

Glasgow

L22 0LG

Liverpool

L7 8XP

Liverpool

SE5 9RS

London

Unknown

London

M15 6SX

Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY