Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Secondary Hyperparathyroidism
Interventions
DRUG

Sensipar (Cinacalcet HCl)

All enrolled subjects receive study medication at a starting dose of 30 mg cinacalcet once daily beginning on day 1. Possible sequential doses are 30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily. During the study, dose adjustment (dose increase/decrease/withholding) is based upon iPTH, serum calcium, and subject safety information. Subjects swallowed tablets whole without biting or chewing. Subjects were dispensed investigational product every 4 weeks starting from Day 1 through to Week 48.

Trial Locations (55)

1000

Research Site, Skopje

1070

Research Site, Brussels

1083

Research Site, Budapest

2020

Research Site, Antwerp

2060

Research Site, Antwerp

3000

Research Site, Leuven

3526

Research Site, Miskolc

4000

Research Site, Liège

4012

Research Site, Debrecen

4400

Research Site, Nyíregyháza

8091

Research Site, Zurich

9023

Research Site, Győr

10032

Research Site, New York

10467

Research Site, The Bronx

11021

Research Site, Great Neck

11355

Research Site, Flushing

16132

Research Site, Genova

18103

Research Site, Allentown

20162

Research Site, Milan

21205

Research Site, Baltimore

26100

Research Site, Cremona

28046

Research Site, Madrid

28922

Research Site, Alcorcón

33334

Research Site, Fort Lauderdale

35360

Research Site, Izmir

39008

Research Site, Santander

60201

Research Site, Evanston

63110

Research Site, St Louis

66026

Research Site, Ortona CH

70121

Research Site, New Orleans

77076

Research Site, Houston

80220

Research Site, Denver

83100

Research Site, Avellino

85012

Research Site, Phoenix

90095

Research Site, Los Angeles

06511

Research Site, New Haven

07666

Research Site, Teaneck

500 05

Research Site, Hradec Králové

169 00

Research Site, Prague

00122

Research Site, Ostia RM

00149

Research Site, Roma

00184

Research Site, Roma

00133

Research Site, Roma (RM)

31-501

Research Site, Krakow

90-153

Research Site, Lodz

50-556

Research Site, Wroclaw

4250-499

Research Site, Porto

2800-455

Research Site, Almada

2765-294

Research Site, Estoril

4810-273

Research Site, Guimarães

4200-072

Research Site, Porto

2600-076

Research Site, Vila Franca de Xira

08003

Research Site, Barcelona

08036

Research Site, Barcelona

M13 9WL

Research Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY