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

PHASE3CompletedINTERVENTIONAL
Enrollment

508

Participants

Timeline

Start Date

March 12, 2013

Primary Completion Date

May 22, 2014

Study Completion Date

June 12, 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 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 (118)

1020

Research Site, Brussels

1037

Research Site, Budapest

1090

Research Site, Vienna

1115

Research Site, Budapest

2065

Research Site, St Leonards

2170

Research Site, Liverpool

3000

Research Site, Leuven

3004

Research Site, Prahan

3050

Research Site, Parkville

4000

Research Site, Liège

4010

Research Site, Linz

6500

Research Site, Baja

7331

Research Site, Baudour

7400

Research Site, Kaposvár

7624

Research Site, Pécs

8036

Research Site, Graz

9023

Research Site, Győr

9300

Research Site, Aalst

10461

Research Site, The Bronx

10704

Research Site, Yonkers

11235

Research Site, Brooklyn

11422

Research Site, Rosedale

12053

Research Site, Berlin

14226

Research Site, Amherst

18104

Research Site, Allentown

19106

Research Site, Philadelphia

19118

Research Site, Philadelphia

20122

Research Site, Milan

22020

Research Site, San Fermo Della Battaglia (CO)

22033

Research Site, Fairfax

22100

Research Site, Nahariya

23116

Research Site, Mechanicsville

23502

Research Site, Norfolk

24105

Research Site, Kiel

24701

Research Site, Bluefield

27100

Research Site, Pavia

27599

Research Site, Chapel Hill

27704

Research Site, Durham

28041

Research Site, Madrid

28046

Research Site, Madrid

29118

Research Site, Orangeburg

29150

Research Site, Sumter

33028

Research Site, Pembroke Pines

35211

Research Site, Birmingham

37126

Research Site, Verona

37205

Research Site, Nashville

38401

Research Site, Columbia

38801

Research Site, Tupelo

39008

Research Site, Santander

44200

Research Site, Nantes

48195

Research Site, Southgate

48236

Research Site, Detroit

48341

Research Site, Pontiac

49007

Research Site, Kalamazoo

51092

Research Site, Reims

60201

Research Site, Evanston

64111

Research Site, Kansas City

64239

Research Site, Tel Aviv

71603

Research Site, Pine Bluff

75050

Research Site, Grand Prairie

75701

Research Site, Tyler

76063

Research Site, Mansfield

76105

Research Site, Fort Worth

76164

Research Site, Fort Worth

77030

Research Site, Houston

78052

Research Site, Villingen-Schwenningen

78205

Research Site, San Antonio

78215

Research Site, San Antonio

78229

Research Site, San Antonio

78278

Research Site, Ashkelon

78758

Research Site, Austin

80054

Research Site, Salouël

80131

Research Site, Napoli

83642

Research Site, Meridian

86021

Research Site, Poitiers

89511

Research Site, Reno

90025

Research Site, Los Angeles

90262

Research Site, Lynwood

90603

Research Site, Whittier

90712

Research Site, Lakewood

91324

Research Site, Northridge

91402

Research Site, Panorama City

91702

Research Site, Azusa

91723

Research Site, Covina

91762

Research Site, Ontario

93400

Research Site, Saint-Ouen

95825

Research Site, Sacramento

191104

Research Site, Saint Petersburg

195067

Research Site, Saint Petersburg

195257

Research Site, Saint Petersburg

196247

Research Site, Saint Petersburg

198510

Research Site, Saint Petersburg

01107

Research Site, Springfield

L6R 3J7

Research Site, Brampton

J4V 2H1

Research Site, Greenfield Park

H1T 2M4

Research Site, Montreal

G1R 2J6

Research Site, Québec

500 05

Research Site, Hradec Králové

169 00

Research Site, Prague

140 00

Research Site, Praha 4 - Nusle

684 01

Research Site, Slavkov u Brna

739 61

Research Site, Třinec

01307

Research Site, Dresden

15-540

Research Site, Bialystok

02-006

Research Site, Warsaw

02-097

Research Site, Warsaw

04-141

Research Site, Warsaw

51-124

Research Site, Wroclaw

87-100

Research Site, Zamość

08003

Research Site, Barcelona

08025

Research Site, Barcelona

CB2 2QQ

Research Site, Cambridge

CV2 2DX

Research Site, Coventry

G11 6NT

Research Site, Glasgow

NW3 2QG

Research Site, London

NG5 1PB

Research Site, Nottingham

M6 8HD

Research Site, Salford

S5 7AU

Research Site, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY