Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

PHASE3CompletedINTERVENTIONAL
Enrollment

515

Participants

Timeline

Start Date

March 12, 2013

Primary Completion Date

April 14, 2014

Study Completion Date

May 9, 2014

Conditions
Hyperparathyroidism, Secondary
Interventions
DRUG

Etelcalcetide

Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at weeks 5, 9, 13, and 17 (4-week intervals) by 2.5 mg or 5 mg on the basis of the predialysis parathyroid hormone and corrected calcium concentrations obtained in the prior week. The minimum dose was 2.5 mg and the maximum dose was 15 mg.

DRUG

Placebo

Administered intravenously (IV) three times per week.

Trial Locations (106)

1076

Research Site, Budapest

1090

Research Site, Brussels

1106

Research Site, Budapest

1200

Research Site, Brussels

2145

Research Site, Westmead

2500

Research Site, Esztergom

2820

Research Site, Bonheiden

3168

Research Site, Clayton

3526

Research Site, Miskolc

4000

Research Site, Liège

4102

Research Site, Brisbane

5000

Research Site, Adelaide

6000

Research Site, Kecskemét

7500

Research Site, Tournai

8800

Research Site, Roeselare

8900

Research Site, Zalaegerszeg

11021

Research Site, Great Neck

11212

Research Site, Brooklyn

11365

Research Site, Fresh Meadows

13253

Research Site, Marseille

13385

Research Site, Marseille

14000

Research Site, Caen

14004

Research Site, Córdoba

18012

Research Site, Granada

20142

Research Site, Milan

20744

Research Site, Ft. Washington

20817

Research Site, Bethesda

22304

Research Site, Alexandria

23900

Research Site, Lecco

28207

Research Site, Charlotte

28222

Research Site, Majadahonda

28562

Research Site, New Bern

29203

Research Site, Columbia

30901

Research Site, Augusta

31217

Research Site, Macon

33075

Research Site, Bordeaux

33173

Research Site, Miami

33313

Research Site, Lauderdale Lakes

34471

Research Site, Ocala

36608

Research Site, Mobile

37408

Research Site, Chattanooga

37923

Research Site, Knoxville

38000

Research Site, Grenoble

39601

Research Site, Brookhaven

44281

Research Site, Kfar Saba

45206

Research Site, Cincinnati

46410

Research Site, Merrillville

48202

Research Site, Detroit

52621

Research Site, Tel Litwinsky

60031

Research Site, Gurnee

60131

Research Site, Ancona

60616

Research Site, Chicago

66046

Research Site, Perpignan

68510

Research Site, Lincoln

70300

Research Site, Ẕerifin

71101

Research Site, Shreveport

76015

Research Site, Arlington

77054

Research Site, Houston

79430

Research Site, Lubbock

80230

Research Site, Denver

89106

Research Site, Las Vegas

90022

Research Site, Los Angeles

90211

Research Site, Beverly Hills

90650

Research Site, Norwalk

91120

Research Site, Jerusalem

91205

Research Site, Glendale

91324

Research Site, Northridge

91702

Research Site, Azusa

91910

Research Site, Chula Vista

92501

Research Site, Riverside

93065

Research Site, Simi Valley

94534

Research Site, Fairfield

99089

Research Site, Erfurt

123183

Research Site, Moscow

150062

Research Site, Yaroslavl

197110

Research Site, Saint Petersburg

06902

Research Site, Stamford

67214-2998

Research Site, Wichita

07724

Research Site, Eatontown

05701

Research Site, Rutland

26506-9165

Research Site, Morgantown

T6G 2B7

Research Site, Edmonton

V3L 0A6

Research Site, New Westminster

B3H 1V7

Research Site, Halifax

M5C 2T2

Research Site, Toronto

H4J 1C5

Research Site, Montreal

741 01

Research Site, Nový Jičín

301 00

Research Site, Pilsen

140 21

Research Site, Prague

562 18

Research Site, Ústí nad Orlicí

09045

Research Site, Quartu Sant'Elena CA

1081 HV

Research Site, Amsterdam

7511 JX

Research Site, Enschede

3079 DZ

Research Site, Rotterdam

5912 BL

Research Site, Venlo

80-952

Research Site, Gdansk

87-400

Research Site, Golub-Dobrzyń

31-501

Research Site, Krakow

90-153

Research Site, Lodz

44-200

Research Site, Rybnik

04-749

Research Site, Warsaw

08035

Research Site, Barcelona

08036

Research Site, Barcelona

651 85

Research Site, Karlstad

141 86

Research Site, Stockholm

751 85

Research Site, Uppsala

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT01788046 - Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis | Biotech Hunter | Biotech Hunter