Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis

PHASE3TerminatedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

November 7, 2014

Primary Completion Date

June 23, 2016

Study Completion Date

June 23, 2016

Conditions
Chronic Kidney Disease, Secondary Hyperparathyroidism
Interventions
DRUG

Cinacalcet HCl

Capsules were opened and either sprinkled onto soft food (≥ 5 mg dose) or suspended into a sucrose syrup (≥ 2.5 mg dose) to create a liquid suspension for administration. Tablets were used for doses of 30 mg and higher in participants who could swallow tablets.

DIETARY_SUPPLEMENT

Standard of Care

Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.

Trial Locations (60)

1020

Research Site, Brussels

1023

Research Site, Grafton, Auckland

1083

Research Site, Budapest

3000

Research Site, Leuven

6720

Research Site, Szeged

9000

Research Site, Ghent

10029

Research Site, New York

10126

Research Site, Torino

10467

Research Site, The Bronx

11527

Research Site, Athens

13385

Research Site, Marseille

16147

Research Site, Genova

19104

Research Site, Philadelphia

19803

Research Site, Wilmington

21287

Research Site, Baltimore

27834

Research Site, Greenville

30322

Research Site, Atlanta

30625

Research Site, Hanover

35043

Research Site, Marburg

39216

Research Site, Jackson

40202

Research Site, Louisville

43205

Research Site, Columbus

44106

Research Site, Cleveland

45229

Research Site, Cincinnati

48201

Research Site, Detroit

52242

Research Site, Iowa City

54642

Research Site, Thessaloniki

55454

Research Site, Minneapolis

59800

Research Site, Lille

60612

Research Site, Chicago

63104

Research Site, St Louis

63110

Research Site, St Louis

64108

Research Site, Kansas City

69120

Research Site, Heidelberg

69677

Research Site, Bron

75012

Research Site, Paris

75015

Research Site, Paris

75019

Research Site, Paris

75235

Research Site, Dallas

77030

Research Site, Houston

78229

Research Site, San Antonio

80129

Research Site, Napoli

84113

Research Site, Salt Lake City

90027

Research Site, Los Angeles

107014

Research Site, Moscow

198205

Research Site, Saint Petersburg

443095

Research Site, Samara

02115

Research Site, Boston

07052

Research Site, West Orange

150 06

Research Site, Prague

06202

Research Site, Nice

08406

Research Site, Vilinus

30-663

Research Site, Krakow

93-338

Research Site, Lodz

00-576

Research Site, Warsaw

4050 371

Research Site, Porto

040 11

Research Site, Košice

08035

Research Site, Barcelona

08950

Research Site, Espluques de LLobregat

01135

Research Site, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY