Back to resultsEfficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
Primary Purpose
Hyperparathyroidism, Secondary
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Etelcalcetide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperparathyroidism, Secondary focused on measuring Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
Eligibility Criteria
Inclusion Criteria:
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- Subject is 18 years of age or older.
- Subject must be receiving hemodialysis 3 times weekly for at least 3 months
- Subject agrees to not participate in another study of an investigational agent during the study.
- Other Inclusion Criteria may apply
Exclusion Criteria:
- Currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening.
- Other investigational procedures while participating in this study are excluded.
- Anticipated or scheduled parathyroidectomy during the study period.
- Subject has received a parathyroidectomy within 3 months prior to dosing.
- Anticipated or scheduled kidney transplant during the study period.
- Subject has known sensitivity to any of the products or components to be administered during dosing.
- Subject has participated in a prior clinical trial of AMG 416 (also referred to as KAI-4169).
- Subject has received cinacalcet within the 4 weeks prior to screening labs (treatment with cinacalcet is prohibited during the study).
- Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.
- Other Exclusion Criteria may apply
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Etelcalcetide
Placebo
Arm Description
Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times a week, for 26 weeks.
Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase
Participants who did not have any scheduled assessments during the EAP were considered non-responders.
Secondary Outcome Measures
Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase
Participants who had no scheduled assessments during the EAP were considered non-responders.
Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase
Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase
Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product During the Efficacy Assessment Phase
Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01785849
Brief Title
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 12, 2013 (Actual)
Primary Completion Date
May 22, 2014 (Actual)
Study Completion Date
June 12, 2014 (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
This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Secondary
Keywords
Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
508 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etelcalcetide
Arm Type
Experimental
Arm Description
Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times a week, for 26 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
Intervention Type
Drug
Intervention Name(s)
Etelcalcetide
Other Intervention Name(s)
AMG 416, KAI-4169
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered intravenously (IV) three times per week.
Primary Outcome Measure Information:
Title
Percentage of Participants With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase
Description
Participants who did not have any scheduled assessments during the EAP were considered non-responders.
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 Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase
Description
Participants who had no scheduled assessments during the EAP were considered non-responders.
Time Frame
Baseline and the efficacy assessment phase (Week 20 to Week 27)
Title
Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase
Time Frame
Baseline and the Efficacy Assessment Phase (Week 20 to Week 27)
Title
Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase
Time Frame
Baseline and the efficacy assessment phase (Week 20 to Week 27)
Title
Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product During the Efficacy Assessment Phase
Time Frame
Baseline and the efficacy assessment phase (Week 20 to Week 27)
Title
Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase
Time Frame
Baseline and the efficacy assessment phase (Week 20 to Week 27)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
Subject is 18 years of age or older.
Subject must be receiving hemodialysis 3 times weekly for at least 3 months
Subject agrees to not participate in another study of an investigational agent during the study.
Other Inclusion Criteria may apply
Exclusion Criteria:
Currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening.
Other investigational procedures while participating in this study are excluded.
Anticipated or scheduled parathyroidectomy during the study period.
Subject has received a parathyroidectomy within 3 months prior to dosing.
Anticipated or scheduled kidney transplant during the study period.
Subject has known sensitivity to any of the products or components to be administered during dosing.
Subject has participated in a prior clinical trial of AMG 416 (also referred to as KAI-4169).
Subject has received cinacalcet within the 4 weeks prior to screening labs (treatment with cinacalcet is prohibited during the study).
Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.
Other Exclusion 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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
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Research Site
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
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United States
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Research Site
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Azusa
State/Province
California
ZIP/Postal Code
91702
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United States
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Research Site
City
Covina
State/Province
California
ZIP/Postal Code
91723
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United States
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Research Site
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
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United States
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Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
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United States
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Research Site
City
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
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Research Site
City
Northridge
State/Province
California
ZIP/Postal Code
91324
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United States
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Research Site
City
Ontario
State/Province
California
ZIP/Postal Code
91762
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United States
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Research Site
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Panorama City
State/Province
California
ZIP/Postal Code
91402
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United States
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Research Site
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Sacramento
State/Province
California
ZIP/Postal Code
95825
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United States
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Research Site
City
Whittier
State/Province
California
ZIP/Postal Code
90603
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United States
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Research Site
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Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
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United States
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Research Site
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Meridian
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Idaho
ZIP/Postal Code
83642
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United States
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Research Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
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United States
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Springfield
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Massachusetts
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01107
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United States
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Detroit
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Michigan
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48236
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United States
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Kalamazoo
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Michigan
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49007
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United States
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Pontiac
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Michigan
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48341
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United States
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Southgate
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Michigan
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48195
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United States
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Tupelo
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Mississippi
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38801
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Kansas City
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Missouri
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64111
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United States
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Reno
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Nevada
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89511
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United States
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Amherst
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New York
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14226
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United States
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Bronx
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New York
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10461
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United States
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Brooklyn
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New York
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11235
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United States
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Rosedale
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New York
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11422
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United States
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Yonkers
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New York
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10704
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Chapel Hill
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North Carolina
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27599
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United States
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Durham
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North Carolina
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27704
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United States
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Allentown
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Pennsylvania
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18104
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United States
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Philadelphia
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Pennsylvania
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19106
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United States
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Philadelphia
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Pennsylvania
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19118
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Orangeburg
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South Carolina
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29118
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Sumter
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South Carolina
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29150
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United States
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Columbia
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Tennessee
ZIP/Postal Code
38401
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United States
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Nashville
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Tennessee
ZIP/Postal Code
37205
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United States
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Austin
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Texas
ZIP/Postal Code
78758
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United States
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Fort Worth
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Texas
ZIP/Postal Code
76105
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United States
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City
Fort Worth
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Texas
ZIP/Postal Code
76164
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United States
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City
Grand Prairie
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Texas
ZIP/Postal Code
75050
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United States
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Houston
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Texas
ZIP/Postal Code
77030
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United States
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City
Mansfield
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Texas
ZIP/Postal Code
76063
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United States
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Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
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United States
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City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
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United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
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United States
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Research Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
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United States
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Research Site
City
Fairfax
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Virginia
ZIP/Postal Code
22033
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United States
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Research Site
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Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116
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United States
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Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
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United States
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Bluefield
State/Province
West Virginia
ZIP/Postal Code
24701
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United States
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Research Site
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Liverpool
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New South Wales
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2170
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Australia
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Research Site
City
St Leonards
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New South Wales
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2065
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Australia
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Research Site
City
Parkville
State/Province
Victoria
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3050
Country
Australia
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Research Site
City
Prahan
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Research Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Research Site
City
Baudour
ZIP/Postal Code
7331
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
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
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 05
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
Nantes Cedex 01
ZIP/Postal Code
44200
Country
France
Facility Name
Research Site
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Research Site
City
Reims Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Research Site
City
Saint-Ouen
ZIP/Postal Code
93400
Country
France
Facility Name
Research Site
City
Salouel Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
12053
Country
Germany
Facility Name
Research Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Research Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Research Site
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
Research Site
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1037
Country
Hungary
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
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Research Site
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Research Site
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Research Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Research Site
City
San Fermo Della Battaglia (CO)
ZIP/Postal Code
22020
Country
Italy
Facility Name
Research Site
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-006
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Research Site
City
Zamosc
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
196247
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
195067
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Research Site
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08003
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08025
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Research Site
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Research Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Research Site
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28097355
Citation
Block GA, Bushinsky DA, Cunningham J, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Mix TC, Moe SM, Patel UD, Silver J, Spiegel DM, Sterling L, Walsh L, Chertow GM. Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials. JAMA. 2017 Jan 10;317(2):146-155. doi: 10.1001/jama.2016.19456.
Results Reference
background
PubMed Identifier
28274835
Citation
Kroenke MA, Weeraratne DK, Deng H, Sloey B, Subramanian R, Wu B, Serenko M, Hock MB. Clinical immunogenicity of the d-amino acid peptide therapeutic etelcalcetide: Method development challenges and anti-drug antibody clinical impact assessments. J Immunol Methods. 2017 Jun;445:37-44. doi: 10.1016/j.jim.2017.03.005. Epub 2017 Mar 6.
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
28508378
Citation
Chen P, Narayanan A, Wu B, Gisleskog PO, Gibbs JP, Chow AT, Melhem M. Population Pharmacokinetic and Pharmacodynamic Modeling of Etelcalcetide in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Hemodialysis. Clin Pharmacokinet. 2018 Jan;57(1):71-85. doi: 10.1007/s40262-017-0550-4.
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
31317120
Citation
Cunningham J, Block GA, Chertow GM, Cooper K, Evenepoel P, Iles J, Sun Y, Urena-Torres P, Bushinsky DA. Etelcalcetide Is Effective at All Levels of Severity of Secondary Hyperparathyroidism in Hemodialysis Patients. Kidney Int Rep. 2019 Apr 16;4(7):987-994. doi: 10.1016/j.ekir.2019.04.010. eCollection 2019 Jul.
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
PubMed Identifier
31199098
Citation
Hain D, Tomlin H, Gibson C. Administration of Etelcalcetide for the Treatment of Secondary Hyperparathyroidism in Patients with CKD-MBD on Hemodialysis: A Nephrology Nursing Perspective. Nephrol Nurs J. 2019 May-Jun;46(3):315-290.
Results Reference
background
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http://www.amgentrials.com
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AmgenTrials clinical trials website
Learn more about this trial
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
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