Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

1,370

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

April 18, 2017

Study Completion Date

April 18, 2017

Conditions
Chronic Kidney DiseaseAutosomal Dominant Polycystic Kidney Disease
Interventions
DRUG

Tolvaptan (OPC-41061)

Tolvaptan tablets (15 or 30 mg) will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later.

DRUG

Placebo

Matching placebo tablets will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later

Trial Locations (230)

400

Liège

1032

Budapest

1090

Brussels

1200

Brussels

2050

Camperdown

2065

St Leonards

2139

Concord

2145

Westmead

2305

New Lambton Heights

2650

Antwerp

3000

Leuven

3050

Parkville

3073

Reservoir

3121

Richmond

4001

Durban

4068

Stavanger

4102

Woolloongabba

5000

Adelaide

Odense C

5021

Bergen

6000

Junín

Perth

6720

Szeged

7250

Launceston

7500

Holstebro

7623

Pécs

7925

Cape Town

8000

Aarhus C

8500

Kortrijk

8800

Viborg

9000

Ghent

9100

Aalborg

9300

Aalst

10016

New York

10021

New York

10032

New York

11422

Rosedale

11501

Mineola

13005

Ciudad Real

14186

Stockholm

14215

Buffalo

18017

Bethlehem

18901

Doylestown

19104

Philadelphia

20122

Milan

20132

Milan

20770

Greenbelt

20850

Rockville

20906

Wheaton

21201

Baltimore

22100

Nahariya

22205

Arlington

22908

Charlottesville

23507

Norfolk

23900

Lecco

25018

Montichiari

26506

Morgantown

27100

Pavia

27103

Winston-Salem

28041

Madrid

28046

Madrid

28207

Charlotte

28801

Asheville

29118

Orangeburg

29203

Columbia

29425

Charleston

29609

Brest

30322

Atlanta

30625

Hanover

30909

Augusta

31059

Toulouse

32216

Jacksonville

33000

Bordeaux

33150

Miami

33614

Tampa

33952

Port Charlotte

34239

Tel Aviv

34295

Montpellier

34471

Ocala

34667

Hudson

35294

Birmingham

35805

Huntsville

36617

Mobile

37205

Nashville

37232

Nashville

38043

Grenoble

39723

Knoxville

40138

Bologna

40210

Düsseldorf

41009

Seville

41071

Seville

41124

Modena

41345

Gothenburg

42055

Saint-Priest-En-Jarez

43210

Columbus

44106

Cleveland

44195

Cleveland

44302

Akron

45147

Essen

45206

Cincinnati

46017

Valencia

48066

Roseville

48202

Detroit

48341

Pontiac

49007

Kalamazoo

51090

Reims

51401

Jilemnice

52621

Ramat Gan

54511

Vandœuvre-lès-Nancy

54601

La Crosse

55404

Minneapolis

55905

Rochester

58122

Fargo

58185

Linköping

58201

Grand Forks

60126

Torrette Di Ancona

60637

Chicago

63110

St Louis

65191

Wiesbaden

66160

Kansas City

67214

Wichita

69120

Heidelberg

69437

Lyon

69495

Pierre-Bénite

70124

Bari

70185

Örebro

70503

Lafayette

70808

Baton Rouge

75185

Uppsala

76015

Arlington

77030

Houston

78503

McAllen

80045

Aurora

80131

Napoli

80210

Denver

81675

Munich

83642

Meridian

85284

Tempe

85381

Phoenix

85745

Tucson

89128

Las Vegas

89511

Reno

90022

Los Angeles

90025

Los Angeles

90471

Nuremberg

92037

La Jolla

94143

San Francisco

98686

Portland

98801

Wenatchee

150062

Yaroslavl

194044

Saint Petersburg

197110

Saint Petersburg

410649

Oradea

660062

Krasnoyarsk

4941492

Petah Tikva

7830604

Ashkelon

9112001

Jerusalem

06520

New Haven

02215

Boston

01107

Springfield

07724

Eatontown

08043

Voorhees Township

27599-7155

Chapel Hill

77030-3411

Houston

05401

Burlington

B8000FTD

Bahía Blanca

C1093AAS

Ciudad Autonoma

C1119ACN

Ciudad Autonoma

C1425APQ

Ciudad Autonoma

C1429BWN

Ciudad Autonoma

C1431FWO

Ciudad Autonoma

B2700CPM

Pergamino

B1629ODT

Pilar

B1872EEA

Sarandí

X5000JHQ

Córdoba

X5003DCE

Córdoba

X5016KEH

Córdoba

T6G 2B7

Edmonton

A1B 3V6

St. John's

M1H 3G4

Scarborough Village

M4C 5T2

Toronto

M5C 2T2

Toronto

M5G 2N2

Toronto

J4V 2H1

Greenfield Park

H3A 1A1

Montreal

H4J 1C5

Montreal

625 00

Brno

370 01

České Budějovice

500 05

Hradec Králové

586 33

Jihlava

460 63

Liberec

708 52

Ostrava

128 08

Prague

140 21

Prague

390 03

Tábor

01307

Dresden

9713 GZ

Groningen

6525 GA

Nijmegen

0424

Oslo

06-400

Ciechanów

87-400

Golub-Dobrzyń

31-559

Krakow

92-213

Lodz

92-313

Lodz

20-954

Lublin

04-749

Warsaw

50-556

Wroclaw

00918

San Juan

011794

Bucharest

022328

Bucharest

0002

Pretoria

08907

L'Hospitalet de Llobregat

141 86

Stockholm

EX2 5DW

Exeter

HU3 2JZ

Hull

BN2 5BE

Brighton

NW3 2QG

London

M13 9WL

Manchester

M6 8HD

Salford

SG1 4AB

Stevenage

IV2 3UJ

Inverness

LE5 4PW

Leicester

EH16 4SA

Edinburgh

L7 8XP

Liverpool

TS4 3BW

Middlesbrough

S5 7AU

Sheffield

ST4 6QG

Stoke-on-Trent

NE7 7DN

Newcastle upon Tyne

CV2 2DX

Coventry

SA6 6NL

Swansea

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT02160145 - Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Biotech Hunter | Biotech Hunter