Pediatric Chronic Kidney Disease Safety and Efficacy

PHASE3TerminatedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

June 28, 2011

Primary Completion Date

April 30, 2014

Conditions
Chronic Kidney DiseaseHyperparathyroidismHyperparathyroidism, SecondaryKidney DiseaseSecondary Hyperparathyroidism
Interventions
DRUG

cinacalcet capsule

Cinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing.

DRUG

placebo

Placebo tablets and capsules for sprinkling identical to active treatment.

DRUG

Standard of Care

All participants, regardless of treatment assignment, will receive standard of care with vitamin D sterols (calcitriol and its analogs), as prescribed by the treating physician.

Trial Locations (51)

1020

Research Site, Brussels

1083

Research Site, Budapest

2031

Research Site, Randwick

2145

Research Site, Westmead

2650

Research Site, Edegem

3000

Research Site, Leuven

3052

Research Site, Parkville

4029

Research Site, Herston

4032

Research Site, Debrecen

6720

Research Site, Szeged

7623

Research Site, Pécs

9000

Research Site, Ghent

10467

Research Site, The Bronx

19104

Research Site, Philadelphia

20219

Research Site, Aguascalientes

21287

Research Site, Baltimore

22908

Research Site, Charlottesville

27834

Research Site, Greenville

28046

Research Site, Madrid

32610

Research Site, Gainesville

35043

Research Site, Marburg

35233

Research Site, Birmingham

45229

Research Site, Cincinnati

46026

Research Site, Valencia

48903

Research Site, Barakaldo

Research Site, Barakaldo

63104

Research Site, St Louis

63110

Research Site, St Louis

64108

Research Site, Kansas City

69120

Research Site, Heidelberg

77030

Research Site, Houston

78229

Research Site, San Antonio

90095

Research Site, Los Angeles

94143

Research Site, San Francisco

97227

Research Site, Portland

107014

Research Site, Moscow

198205

Research Site, Saint Petersburg

443095

Research Site, Samara

02115

Research Site, Boston

07039

Research Site, Livingston

04530

Research Site, Mexico City

80-952

Research Site, Gdansk

66-400

Research Site, Gorzów Wielkopolski

93-338

Research Site, Lodz

00-576

Research Site, Warsaw

04-730

Research Site, Warsaw

974 09

Research Site, Banská Bystrica

833 40

Research Site, Bratislava

040 11

Research Site, Košice

08035

Research Site, Barcelona

Research Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT01277510 - Pediatric Chronic Kidney Disease Safety and Efficacy | Biotech Hunter | Biotech Hunter