Back to resultsHead-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
Primary Purpose
Secondary Hyperparathyroidism, Chronic Kidney Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Etelcalcetide
Cinacalcet
Oral Placebo
Intravenous Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Secondary Hyperparathyroidism, renal, kidney, kidneys, dialysis, hemodialysis, chronic kidney disease, CKD, SHPT
Eligibility Criteria
Inclusion Criteria:
- Eligible subjects must be receiving adequate thrice weekly maintenance hemodialysis with a dialysate calcium concentration ≥ 2.5 mEq/L for at least 3 months prior to screening laboratory assessments
- Subjects must have SHPT as defined by one central laboratory screening predialysis serum PTH value > 500 pg/mL, measured on separate days within 2 weeks prior to randomization
- Subjects must have one serum cCa value ≥ 8.3 mg/dL obtained before dialysis within 2 weeks of the date of randomization
- Subjects receiving calcium supplements must have no more than a maximum dose change of 50% within 2 weeks before screening laboratory assessments are obtained, and the dose must remain unchanged through randomization
Exclusion Criteria:
- Eligible subjects cannot have received cinacalcet during the 3 months preceding the first screening laboratory assessment
- Other criteria may apply
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Cinacalcet
Etelcalcetide
Arm Description
Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Outcomes
Primary Outcome Measures
Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis
Secondary Outcome Measures
Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase
Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase
Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks
Participants completed the Nausea/Vomiting Symptom Assessment (NVSA) questionnaire daily. This questionnaire asked participants to indicate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined) and if they had vomited in the past 24 hours. A day of vomiting or nausea was defined as those where the severity of nausea score was > 0 or where the episodes of vomiting score was > 0.
Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase
Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase
Mean Severity of Nausea in the First 8 Weeks
Severity of nausea was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asked participants to rate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined). For each participant, the mean severity of nausea was calculated by averaging all available daily severities (including zeroes) reported in the first 8 weeks.
Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks
The number of vomiting episodes was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asks participants on a daily basis how many times they vomited in the past 24 hours. The number of episodes in a week is the sum of all reported daily episodes in the week.
For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01896232
Brief Title
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
Official Title
A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 13, 2013 (Actual)
Primary Completion Date
November 12, 2014 (Actual)
Study Completion Date
January 8, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, Chronic Kidney Disease
Keywords
Secondary Hyperparathyroidism, renal, kidney, kidneys, dialysis, hemodialysis, chronic kidney disease, CKD, SHPT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
683 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cinacalcet
Arm Type
Active Comparator
Arm Description
Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
Arm Title
Etelcalcetide
Arm Type
Experimental
Arm Description
Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Intervention Type
Drug
Intervention Name(s)
Etelcalcetide
Other Intervention Name(s)
AMG 416
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cinacalcet
Other Intervention Name(s)
Sensipar®, Mimpara®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral Placebo
Intervention Description
Administered orally once a day.
Intervention Type
Drug
Intervention Name(s)
Intravenous Placebo
Intervention Description
Administered intravenously (IV) three times per week.
Primary Outcome Measure Information:
Title
Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis
Time Frame
Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).
Secondary Outcome Measure Information:
Title
Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase
Time Frame
Baseline and the efficacy assessment phase (Weeks 20 to 27, inclusive).
Title
Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase
Time Frame
Baseline and the efficacy assessment phase (Week 20 to Week 27)
Title
Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks
Description
Participants completed the Nausea/Vomiting Symptom Assessment (NVSA) questionnaire daily. This questionnaire asked participants to indicate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined) and if they had vomited in the past 24 hours. A day of vomiting or nausea was defined as those where the severity of nausea score was > 0 or where the episodes of vomiting score was > 0.
Time Frame
First 8 weeks
Title
Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase
Time Frame
Baseline and the efficacy assessment phase (weeks 20 - 27)
Title
Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase
Time Frame
Efficacy assessment phase (weeks 20 - 27)
Title
Mean Severity of Nausea in the First 8 Weeks
Description
Severity of nausea was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asked participants to rate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined). For each participant, the mean severity of nausea was calculated by averaging all available daily severities (including zeroes) reported in the first 8 weeks.
Time Frame
First 8 weeks
Title
Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks
Description
The number of vomiting episodes was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asks participants on a daily basis how many times they vomited in the past 24 hours. The number of episodes in a week is the sum of all reported daily episodes in the week.
For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.
Time Frame
First 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligible subjects must be receiving adequate thrice weekly maintenance hemodialysis with a dialysate calcium concentration ≥ 2.5 mEq/L for at least 3 months prior to screening laboratory assessments
Subjects must have SHPT as defined by one central laboratory screening predialysis serum PTH value > 500 pg/mL, measured on separate days within 2 weeks prior to randomization
Subjects must have one serum cCa value ≥ 8.3 mg/dL obtained before dialysis within 2 weeks of the date of randomization
Subjects receiving calcium supplements must have no more than a maximum dose change of 50% within 2 weeks before screening laboratory assessments are obtained, and the dose must remain unchanged through randomization
Exclusion Criteria:
Eligible subjects cannot have received cinacalcet during the 3 months preceding the first screening laboratory assessment
Other criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
Research Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93306
Country
United States
Facility Name
Research Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Research Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Research Site
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
Research Site
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
Research Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Research Site
City
La Puente
State/Province
California
ZIP/Postal Code
91744
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Research Site
City
San Gabriel
State/Province
California
ZIP/Postal Code
91776
Country
United States
Facility Name
Research Site
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Research Site
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80002
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Research Site
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Research Site
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80031
Country
United States
Facility Name
Research Site
City
Orange
State/Province
Connecticut
ZIP/Postal Code
06477
Country
United States
Facility Name
Research Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Research Site
City
Pinecrest
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Research Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Research Site
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70501
Country
United States
Facility Name
Research Site
City
Southgate
State/Province
Michigan
ZIP/Postal Code
48195
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Mississippi
ZIP/Postal Code
39705
Country
United States
Facility Name
Research Site
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39501
Country
United States
Facility Name
Research Site
City
Sewell
State/Province
New Jersey
ZIP/Postal Code
08080
Country
United States
Facility Name
Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Research Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Research Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Research Site
City
Ridgewood
State/Province
New York
ZIP/Postal Code
11385
Country
United States
Facility Name
Research Site
City
Rosedale
State/Province
New York
ZIP/Postal Code
11422
Country
United States
Facility Name
Research Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Research Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
Facility Name
Research Site
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23704
Country
United States
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53713
Country
United States
Facility Name
Research Site
City
Feldkirch
ZIP/Postal Code
6807
Country
Austria
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1220
Country
Austria
Facility Name
Research Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Research Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Research Site
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Research Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Research Site
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Research Site
City
St. Johns
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Research Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Research Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Research Site
City
Novy Jicin
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Research Site
City
Praha 4 - Nusle
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Research Site
City
Praha 6
ZIP/Postal Code
169 00
Country
Czechia
Facility Name
Research Site
City
Slavkov u Brna
ZIP/Postal Code
684 01
Country
Czechia
Facility Name
Research Site
City
Trinec
ZIP/Postal Code
739 61
Country
Czechia
Facility Name
Research Site
City
Usti nad Orlici
ZIP/Postal Code
562 18
Country
Czechia
Facility Name
Research Site
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Research Site
City
Fredericia
ZIP/Postal Code
7000
Country
Denmark
Facility Name
Research Site
City
Kobenhavn
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Research Site
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Research Site
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Research Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Research Site
City
Boulogne sur Mer
ZIP/Postal Code
62200
Country
France
Facility Name
Research Site
City
Lille Cedex
ZIP/Postal Code
59800
Country
France
Facility Name
Research Site
City
Nouilly
ZIP/Postal Code
57645
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75011
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Research Site
City
Saint Ouen
ZIP/Postal Code
93400
Country
France
Facility Name
Research Site
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Research Site
City
Saint-Ouen
ZIP/Postal Code
93400
Country
France
Facility Name
Research Site
City
Sainte Foy les Lyon
ZIP/Postal Code
66046
Country
France
Facility Name
Research Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Research Site
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
22297
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Research Site
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Research Site
City
Mettmann
ZIP/Postal Code
40822
Country
Germany
Facility Name
Research Site
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Research Site
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
Research Site
City
Zwickau
ZIP/Postal Code
08060
Country
Germany
Facility Name
Research Site
City
Alexandroupoli
ZIP/Postal Code
68100
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Research Site
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
Research Site
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Research Site
City
Nikaia, Piraeus
ZIP/Postal Code
18454
Country
Greece
Facility Name
Research Site
City
Patra
ZIP/Postal Code
26500
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Research Site
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Research Site
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Research Site
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Research Site
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Research Site
City
Pecs
ZIP/Postal Code
7633
Country
Hungary
Facility Name
Research Site
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Research Site
City
Szigetvar
ZIP/Postal Code
7900
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Research Site
City
Cagliari
ZIP/Postal Code
09134
Country
Italy
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Research Site
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Research Site
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Research Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Research Site
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Facility Name
Research Site
City
San Giovanni Rotondo FG
ZIP/Postal Code
71013
Country
Italy
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1001
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1038
Country
Latvia
Facility Name
Research Site
City
Valmiera
ZIP/Postal Code
4201
Country
Latvia
Facility Name
Research Site
City
Alytus
ZIP/Postal Code
63351
Country
Lithuania
Facility Name
Research Site
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Research Site
City
Kaunas
ZIP/Postal Code
50169
Country
Lithuania
Facility Name
Research Site
City
Kedainiai
ZIP/Postal Code
57164
Country
Lithuania
Facility Name
Research Site
City
Klaipeda
ZIP/Postal Code
LT-93220
Country
Lithuania
Facility Name
Research Site
City
Siauliai
ZIP/Postal Code
76299
Country
Lithuania
Facility Name
Research Site
City
Ukmerge
ZIP/Postal Code
20184
Country
Lithuania
Facility Name
Research Site
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Research Site
City
Papatoetoe, Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Research Site
City
Takapuna, Auckland City
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-104
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-027
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
61-696
Country
Poland
Facility Name
Research Site
City
Sieradz
ZIP/Postal Code
98-200
Country
Poland
Facility Name
Research Site
City
Wadowice
ZIP/Postal Code
34-100
Country
Poland
Facility Name
Research Site
City
Warsawa
ZIP/Postal Code
01-211
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Research Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Research Site
City
Zyrardow
ZIP/Postal Code
96-300
Country
Poland
Facility Name
Research Site
City
Almada
ZIP/Postal Code
2800-455
Country
Portugal
Facility Name
Research Site
City
Aveiro
ZIP/Postal Code
3800-266
Country
Portugal
Facility Name
Research Site
City
Estoril
ZIP/Postal Code
2765-294
Country
Portugal
Facility Name
Research Site
City
Forte Da Casa
ZIP/Postal Code
2625-437
Country
Portugal
Facility Name
Research Site
City
Guimarães
ZIP/Postal Code
4810-273
Country
Portugal
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1750-130
Country
Portugal
Facility Name
Research Site
City
Santo Tirso
ZIP/Postal Code
4780-383
Country
Portugal
Facility Name
Research Site
City
Setubal
ZIP/Postal Code
2900-655
Country
Portugal
Facility Name
Research Site
City
Vila Franca de Xira
ZIP/Postal Code
2600-076
Country
Portugal
Facility Name
Research Site
City
Mitishi
ZIP/Postal Code
141009
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
129327
Country
Russian Federation
Facility Name
Research Site
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
198510
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
193318
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Research Site
City
Cordoba
State/Province
Andalucía
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Puerto Real
State/Province
Andalucía
ZIP/Postal Code
11510
Country
Spain
Facility Name
Research Site
City
Badalona
State/Province
Cataluña
ZIP/Postal Code
08916
Country
Spain
Facility Name
Research Site
City
Lleida
State/Province
Cataluña
ZIP/Postal Code
25198
Country
Spain
Facility Name
Research Site
City
Torrevieja
State/Province
Comunidad Valenciana
ZIP/Postal Code
03186
Country
Spain
Facility Name
Research Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46017
Country
Spain
Facility Name
Research Site
City
Badajoz
State/Province
Extremadura
ZIP/Postal Code
06080
Country
Spain
Facility Name
Research Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Research Site
City
Galdakao
State/Province
País Vasco
ZIP/Postal Code
48960
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
118 67
Country
Sweden
Facility Name
Research Site
City
Trollhättan
ZIP/Postal Code
467 85
Country
Sweden
Facility Name
Research Site
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Research Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Research Site
City
Geneva 14
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Research Site
City
Lausanne
ZIP/Postal Code
1003
Country
Switzerland
Facility Name
Research Site
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Research Site
City
Locarno
ZIP/Postal Code
6600
Country
Switzerland
Facility Name
Research Site
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06810
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34371
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35360
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
28097356
Citation
Block GA, Bushinsky DA, Cheng S, Cunningham J, Dehmel B, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Moe SM, Patel UD, Silver J, Sun Y, Wang H, Chertow GM. Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial. JAMA. 2017 Jan 10;317(2):156-164. doi: 10.1001/jama.2016.19468.
Results Reference
background
PubMed Identifier
29392552
Citation
Stollenwerk B, Iannazzo S, Akehurst R, Adena M, Briggs A, Dehmel B, Parfrey P, Belozeroff V. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet. Pharmacoeconomics. 2018 May;36(5):603-612. doi: 10.1007/s40273-017-0605-2.
Results Reference
background
PubMed Identifier
28803497
Citation
Stollenwerk B, Iannazzo S, Cooper K, Belozeroff V. Exploring the potential value of improved care for secondary hyperparathyroidism with a novel calcimimetic therapy. J Med Econ. 2017 Oct;20(10):1110-1115. doi: 10.1080/13696998.2017.1360309. Epub 2017 Aug 14.
Results Reference
background
PubMed Identifier
29534286
Citation
Wu B, Melhem M, Subramanian R, Chen P, Jaramilla Sloey B, Fouqueray B, Hock MB, Skiles GL, Chow AT, Lee E. Clinical Pharmacokinetics and Pharmacodynamics of Etelcalcetide, a Novel Calcimimetic for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis. J Clin Pharmacol. 2018 Jun;58(6):717-726. doi: 10.1002/jcph.1090. Epub 2018 Mar 13.
Results Reference
background
PubMed Identifier
30875390
Citation
Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.
Results Reference
background
PubMed Identifier
32082556
Citation
Wolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, Sun Y, Tomlin H, Vervloet M, Oberbauer R. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2019 Apr 26;13(1):75-84. doi: 10.1093/ckj/sfz034. eCollection 2020 Feb.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
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