A Study to See Iftolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old withAutosomal Recessive Polycystic Kidney Disease (ARPKD)

PHASE3RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 23, 2023

Primary Completion Date

February 23, 2028

Study Completion Date

February 23, 2028

Conditions
Autosomal Recessive Polycystic Kidney (ARPKD)
Interventions
DRUG

Tolvaptan Suspension

Syrup

DRUG

Tolvaptan Tablets

Tolvaptan (OPC-41061) Tolvaptan tablets will be administered orally as split-dose regimens (15/7.5 mg, 30/15 mg, and 45/15 mg) upon awakening and 8 hours later (twice daily) based on weight if able to swallow tablets.

Trial Locations (23)

1200

RECRUITING

Université Catholique De Louvain And Cliniques St Luc, Brussels

3000

RECRUITING

UZ Leuven, Leuven

8035

RECRUITING

Hospital Universitari Vall D Hebron, Barcelona

8950

RECRUITING

Universitat de Barcelona - Hospital Sant Joan de Deu Barcelona (HSJDB), Esplugues de Llobregat

9000

RECRUITING

Universitair Ziekenhuis Gent, Ghent

15213

WITHDRAWN

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

20010

RECRUITING

Children's National Medical Center, Washington D.C.

21287

RECRUITING

Johns Hopkins Pediatric Specialty Clinic, Baltimore

30322

NOT_YET_RECRUITING

Emory University Hospital, Atlanta

41013

WITHDRAWN

Hospital Universitario Virgen del Rocío Avenida Manuel Siurot, Seville

44195

RECRUITING

Cleveland Clinic, Cleveland

50937

RECRUITING

Universitätsklinikum Köln, Cologne

55905

RECRUITING

Mayo Clinic - Rochester, Rochester

60611

RECRUITING

Northwestern University Feinberg School of Medicine - Ann & Robert H. Lurie Children's Hospital of Chicago - Neonatology, Chicago

70118

WITHDRAWN

Children's Hospital - New Orleans, New Orleans

84113

WITHDRAWN

Primary Children's Hospital, Salt Lake City

46202-5119

WITHDRAWN

Riley Hospital for Children, Indianapolis

48109-5000

RECRUITING

C.S. Mott Children's Hospital, Ann Arbor

45229-3039

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

04-730

WITHDRAWN

"Instytut Pomnik - Centrum Zdrowia Dziecka", Warsaw

15-274

WITHDRAWN

Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa, Bialystok

08208

WITHDRAWN

Hospital Universitari Parc Tauli, Sabadell

WC1N 3JH

RECRUITING

Great Ormond Street Hospital for Children NHS Trust, London

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY