Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

PHASE3CompletedINTERVENTIONAL
Enrollment

683

Participants

Timeline

Start Date

August 13, 2013

Primary Completion Date

November 12, 2014

Study Completion Date

January 8, 2015

Conditions
Secondary HyperparathyroidismChronic Kidney Disease
Interventions
DRUG

Etelcalcetide

Administered intravenously three times per week. The starting dose was 5 mg, titrated up to 15 mg based on serum PTH and corrected calcium levels.

DRUG

Cinacalcet

Cinacalcet was administered orally once a day. The starting dose was 30 mg daily, titrated up to 180 mg daily based on serum PTH and corrected calcium levels.

DRUG

Oral Placebo

Administered orally once a day.

DRUG

Intravenous Placebo

Administered intravenously (IV) three times per week.

Trial Locations (182)

1001

Research Site, Riga

1003

Research Site, Lausanne

1011

Research Site, Lausanne

1038

Research Site, Riga

1115

Research Site, Budapest

1211

Research Site, Geneva

1220

Research Site, Vienna

2025

Research Site, Papatoetoe, Auckland

2100

Research Site, Copenhagen

2143

Research Site, Kistarcsa

3010

Research Site, Bern

3240

Research Site, Hamilton

3500

Research Site, Hasselt

3600

Research Site, Genk

4000

Research Site, Roskilde

4010

Research Site, Linz

4201

Research Site, Valmiera

5000

Research Site, Odense

5001

Research Site, Aarau

6600

Research Site, Locarno

6807

Research Site, Feldkirch

7000

Research Site, Fredericia

7400

Research Site, Kaposvár

7624

Research Site, Pécs

7633

Research Site, Pécs

7900

Research Site, Szigetvár

8000

Research Site, Székesfehérvár

8091

Research Site, Zurich

8500

Research Site, Kortrijk

8800

Research Site, Roeselare

8900

Research Site, Zalaegerszeg

9000

Research Site, Aalborg

9023

Research Site, Győr

10461

Research Site, The Bronx

10617

Research Site, Tallinn

11021

Research Site, Great Neck

11385

Research Site, Ridgewood

11422

Research Site, Rosedale

11501

Research Site, Mineola

11510

Research Site, Puerto Real

11528

Research Site, Athens

13419

Research Site, Tallinn

14004

Research Site, Córdoba

16132

Research Site, Genova

18454

Research Site, Nikaia, Piraeus

19106

Research Site, Philadelphia

20122

Research Site, Milan

20184

Research Site, Ukmerge

22033

Research Site, Fairfax

22297

Research Site, Hamburg

23704

Research Site, Portsmouth

23900

Research Site, Lecco

25198

Research Site, Lleida

26500

Research Site, Pátrai

27100

Research Site, Pavia

28007

Research Site, Madrid

28040

Research Site, Madrid

28401

Research Site, Wilmington

30625

Research Site, Hanover

31008

Research Site, Pamplona

32429

Research Site, Minden

33028

Research Site, Pembroke Pines

33156

Research Site, Pinecrest

33170

Research Site, Pordenone

33614

Research Site, Tampa

34371

Research Site, Istanbul

34890

Research Site, Istanbul

35100

Research Site, Izmir

35340

Research Site, Izmir

35360

Research Site, Izmir

39120

Research Site, Magdeburg

39501

Research Site, Gulfport

39705

Research Site, Columbus

40822

Research Site, Mettmann

41110

Research Site, Larissa

42270

Research Site, Saint-Priest-en-Jarez

43215

Research Site, Columbus

45206

Research Site, Cincinnati

45500

Research Site, Ioannina

46017

Research Site, Valencia

48195

Research Site, Southgate

48960

Research Site, Galdakao

50009

Research Site, Kaunas

50139

Research Site, Florence

50169

Research Site, Kaunas

51014

Research Site, Tartu

52074

Research Site, Aachen

53713

Research Site, Madison

54636

Research Site, Thessaloniki

55100

Research Site, Lucca

56126

Research Site, Pisa

57164

Research Site, Kėdainiai

57645

Research Site, Nouilly

59800

Research Site, Lille

62200

Research Site, Boulogne-sur-Mer

63351

Research Site, Alytus

65191

Research Site, Wiesbaden

66046

Research Site, Sainte-Foy-lès-Lyon

68100

Research Site, Alexandroupoli

70501

Research Site, Lafayette

70808

Research Site, Baton Rouge

71013

Research Site, San Giovanni Rotondo FG

75011

Research Site, Paris

75014

Research Site, Paris

76299

Research Site, Šiauliai

77030

Research Site, Houston

78229

Research Site, San Antonio

80002

Research Site, Arvada

80031

Research Site, Westminster

80045

Research Site, Aurora

80501

Research Site, Longmont

81675

Research Site, München

90022

Research Site, Los Angeles

90603

Research Site, Whittier

91344

Research Site, Granada Hills

91702

Research Site, Azusa

91723

Research Site, Covina

91744

Research Site, La Puente

91776

Research Site, San Gabriel

91910

Research Site, Chula Vista

91942

Research Site, La Mesa

92123

Research Site, San Diego

93306

Research Site, Bakersfield

93309

Research Site, Bakersfield

93400

Research Site, Saint-Ouen

96450

Research Site, Coburg

123182

Research Site, Moscow

129327

Research Site, Moscow

141009

Research Site, Mitishi

150062

Research Site, Yaroslavl

185019

Research Site, Petrozavodsk

191104

Research Site, Saint Petersburg

193318

Research Site, Saint Petersburg

195067

Research Site, Saint Petersburg

197110

Research Site, Saint Petersburg

198510

Research Site, Saint Petersburg

06477

Research Site, Orange

08080

Research Site, Sewell

05401

Research Site, Burlington

T6G 2B7

Research Site, Edmonton

E2L 4L2

Research Site, Saint John

A1B 3V6

Research Site, St. John's

L6R 3J7

Research Site, Brampton

J4V 2H1

Research Site, Greenfield Park

741 01

Research Site, Nový Jičín

169 00

Research Site, Prague

140 00

Research Site, Praha 4 - Nusle

684 01

Research Site, Slavkov u Brna

739 61

Research Site, Třinec

562 18

Research Site, Ústí nad Orlicí

08060

Research Site, Zwickau

09134

Research Site, Cagliari

LT-93220

Research Site, Klaipėda

0622

Research Site, Takapuna, Auckland City

80-104

Research Site, Gdansk

40-027

Research Site, Katowice

60-355

Research Site, Poznan

61-696

Research Site, Poznan

98-200

Research Site, Sieradz

34-100

Research Site, Wadowice

01-211

Research Site, Warsaw

02-507

Research Site, Warsaw

41-800

Research Site, Zabrze

96-300

Research Site, Żyrardów

2800-455

Research Site, Almada

3800-266

Research Site, Aveiro

2765-294

Research Site, Estoril

2625-437

Research Site, Forte Da Casa

4810-273

Research Site, Guimarães

1750-130

Research Site, Lisbon

4780-383

Research Site, Santo Tirso

2900-655

Research Site, Setúbal

2600-076

Research Site, Vila Franca de Xira

08916

Research Site, Badalona

06080

Research Site, Badajoz

03186

Research Site, Torrevieja

205 02

Research Site, Malmo

118 67

Research Site, Stockholm

467 85

Research Site, Trollhättan

06230

Research Site, Ankara

06500

Research Site, Ankara

06810

Research Site, Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT01896232 - Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet | Biotech Hunter | Biotech Hunter