Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism

PHASE2TerminatedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

June 22, 2012

Primary Completion Date

June 3, 2016

Study Completion Date

June 3, 2016

Conditions
Chronic Kidney DiseaseHyperparathyroidism, Secondary
Interventions
DRUG

Cinacalcet hydrochloride

Cinacalcet was provided as 5 mg capsules that were opened, and the contents were either sprinkled on soft food or suspended into a sucrose syrup to create a liquid suspension for administration. All doses were administered with food or shortly after a meal at the same time daily.

DRUG

Standard of Care

Standard of care may have included vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs) at the discretion of the investigator.

Trial Locations (42)

1020

Research Site, Brussels

1023

Research Site, Grafton, Auckland

1083

Research Site, Budapest

3000

Research Site, Leuven

4032

Research Site, Debrecen

6720

Research Site, Szeged

9000

Research Site, Ghent

10126

Research Site, Torino

10467

Research Site, The Bronx

16147

Research Site, Genova

19104

Research Site, Philadelphia

21287

Research Site, Baltimore

27834

Research Site, Greenville

31000

Research Site, Chihuahua City

35233

Research Site, Birmingham

40202

Research Site, Louisville

45229

Research Site, Cincinnati

48109

Research Site, Ann Arbor

52242

Research Site, Iowa City

59800

Research Site, Lille

63110

Research Site, St Louis

64108

Research Site, Kansas City

69120

Research Site, Heidelberg

69677

Research Site, Bron

72202

Research Site, Little Rock

73104

Research Site, Oklahoma City

75012

Research Site, Paris

75015

Research Site, Paris

75019

Research Site, Paris

75390

Research Site, Dallas

77030

Research Site, Houston

78229

Research Site, San Antonio

90095

Research Site, Los Angeles

107014

Research Site, Moscow

198205

Research Site, Saint Petersburg

150 06

Research Site, Prague

00165

Research Site, Roma

1105 AZ

Research Site, Amsterdam

80-952

Research Site, Gdansk

30-663

Research Site, Krakow

00-576

Research Site, Warsaw

040 11

Research Site, Košice

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT01439867 - Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism | Biotech Hunter | Biotech Hunter