Back to resultsExtension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
Primary Purpose
Hyperparathyroidism, Secondary
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Etelcalcetide
Sponsored by
About this trial
This is an interventional treatment trial for Hyperparathyroidism, Secondary focused on measuring Secondary Hyperparathyroidism (SHPT), chrominc kidney disease (CKD), hemodialysis
Eligibility Criteria
Inclusion Criteria:
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01)
- Female subjects who are: post-menopausal (post-menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, have a medical condition that prevents pregnancy, remain abstinent, or are willing to use an acceptable method of effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current study
- Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months
Exclusion Criteria:
- Currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies)
- Subject has known sensitivity to any of the products or components to be administered during dosing
- Subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with AMG 416 in the current study
- Subject is receiving dialysis prescription dialysate calcium concentration < 2.25 mEq/L
- Subject is pregnant or nursing
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Etelcalcetide
Arm Description
Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
A serious adverse event is an AE that met at least 1 of the following criteria:
fatal
life threatening
required in-patient hospitalization or prolongation of existing hospitalization
resulted in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event.
The relationship of each AE to study treatment was assessed by the investigator.
The following AE grading scale was used:
Mild: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required Moderate: Mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalization possible Life-threatening: Extreme limitation in activity, significant assistance required, significant medical intervention/therapy required, hospitalization probable.
Secondary Outcome Measures
Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal
The percentage of participants who maintained plasma parathyroid hormone (PTH) levels within the Kidney Disease Improving Global Outcomes (KDIGO) recommended range of not less than 2x the upper limit of normal (ULN) and not greater than 9x the ULN at months 6, 12, and 18, with the ULN based on the reference range of the assay used at the individual clinical site.
Percentage of Participants With Serum Phosphorus ≤ the ULN
Percentage of participants with serum phosphorus less than or equal to the upper limit of normal for the assay used.
Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL
The percentage of participants with serum corrected calcium (cCa) reported for cumulative time intervals from day 1 through months 6, 12, and 18, using the participant's lowest recorded corrected calcium value during the time interval.
If serum albumin was less than 4.0 g/dL, serum calcium was corrected according to the following formula:
cCa (mg/dL) = total calcium (mg/dL) + (4 - albumin [g/dL])*0.8. If serum albumin was > 4.0 g/dL no correction was made.
Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters
The Common Terminology Criteria for Adverse Events (CTCAE) grades for laboratory parameter values were defined based on the upper/lower limit of normal from the local laboratories contracted by the study centers.
Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies
The number of participants who were binding antibody positive post-baseline with a negative or no result at baseline (where baseline for participants previously treated with etelcalcetide is Day 1 of the first study in which they were exposed to etelcalcetide and for participants previously treated with cinacalcet is the ending time point for study 20120360).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02102204
Brief Title
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
Official Title
A Multicenter Single-arm Extension Study to Describe the Long-term 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
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 25, 2014 (Actual)
Primary Completion Date
November 4, 2016 (Actual)
Study Completion Date
June 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.
Detailed Description
This is a multicenter, single-arm, extension study in which adults with secondary hyperparathyroidism currently receiving hemodialysis and previously treated in Amgen studies 20120231 (NCT01785875), 20120334 (NCT01576146), or 20120360 (NCT01896232) will continue to be treated with etelcalcetide until approximately 2.5 years after the first participant was enrolled.
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), chrominc kidney disease (CKD), hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
902 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etelcalcetide
Arm Type
Experimental
Arm Description
Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
Intervention Type
Drug
Intervention Name(s)
Etelcalcetide
Other Intervention Name(s)
KAI-4169, AMG 416, Parasabiv
Intervention Description
Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
A serious adverse event is an AE that met at least 1 of the following criteria:
fatal
life threatening
required in-patient hospitalization or prolongation of existing hospitalization
resulted in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event.
The relationship of each AE to study treatment was assessed by the investigator.
The following AE grading scale was used:
Mild: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required Moderate: Mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalization possible Life-threatening: Extreme limitation in activity, significant assistance required, significant medical intervention/therapy required, hospitalization probable.
Time Frame
From the date of first dose of etelcalcetide (in the current study) and up to 30 days after the last dose; median duration of treatment was 563 days.
Secondary Outcome Measure Information:
Title
Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal
Description
The percentage of participants who maintained plasma parathyroid hormone (PTH) levels within the Kidney Disease Improving Global Outcomes (KDIGO) recommended range of not less than 2x the upper limit of normal (ULN) and not greater than 9x the ULN at months 6, 12, and 18, with the ULN based on the reference range of the assay used at the individual clinical site.
Time Frame
Months 6, 12, and 18
Title
Percentage of Participants With Serum Phosphorus ≤ the ULN
Description
Percentage of participants with serum phosphorus less than or equal to the upper limit of normal for the assay used.
Time Frame
Months 6, 12, and 18
Title
Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL
Description
The percentage of participants with serum corrected calcium (cCa) reported for cumulative time intervals from day 1 through months 6, 12, and 18, using the participant's lowest recorded corrected calcium value during the time interval.
If serum albumin was less than 4.0 g/dL, serum calcium was corrected according to the following formula:
cCa (mg/dL) = total calcium (mg/dL) + (4 - albumin [g/dL])*0.8. If serum albumin was > 4.0 g/dL no correction was made.
Time Frame
From day 1 to months 6, 12, and 18
Title
Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters
Description
The Common Terminology Criteria for Adverse Events (CTCAE) grades for laboratory parameter values were defined based on the upper/lower limit of normal from the local laboratories contracted by the study centers.
Time Frame
Baseline to end of treatment; median duration of treatment was 563 days.
Title
Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies
Description
The number of participants who were binding antibody positive post-baseline with a negative or no result at baseline (where baseline for participants previously treated with etelcalcetide is Day 1 of the first study in which they were exposed to etelcalcetide and for participants previously treated with cinacalcet is the ending time point for study 20120360).
Time Frame
Baseline and every 6 months (up to 24 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has provided informed consent prior to initiation of any study-specific activities/procedures
Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01)
Female subjects who are: post-menopausal (post-menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, have a medical condition that prevents pregnancy, remain abstinent, or are willing to use an acceptable method of effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current study
Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months
Exclusion Criteria:
Currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies)
Subject has known sensitivity to any of the products or components to be administered during dosing
Subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with AMG 416 in the current study
Subject is receiving dialysis prescription dialysate calcium concentration < 2.25 mEq/L
Subject is pregnant or nursing
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
Facility Name
Research Site
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
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Research Site
City
Azusa
State/Province
California
ZIP/Postal Code
91702
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United States
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Research Site
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Bakersfield
State/Province
California
ZIP/Postal Code
93308
Country
United States
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Research Site
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Cudahy
State/Province
California
ZIP/Postal Code
90201
Country
United States
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Research Site
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
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Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
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Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
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Research Site
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
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Research Site
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
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Research Site
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
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Research Site
City
Vacaville
State/Province
California
ZIP/Postal Code
95687
Country
United States
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Research Site
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
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Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
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Research Site
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80031
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United States
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Research Site
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
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United States
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Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33150
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United States
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Research Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
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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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Tampa
State/Province
Florida
ZIP/Postal Code
33614
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United States
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Research Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
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Research Site
City
Dublin
State/Province
Georgia
ZIP/Postal Code
31021
Country
United States
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Research Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
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Research Site
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60035
Country
United States
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Research Site
City
Merrillville
State/Province
Indiana
ZIP/Postal Code
46410
Country
United States
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Research Site
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-2998
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
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Research Site
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
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Research Site
City
Brookhaven
State/Province
Mississippi
ZIP/Postal Code
39601
Country
United States
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Research Site
City
Columbus
State/Province
Mississippi
ZIP/Postal Code
39705
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United States
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Research Site
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39501
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United States
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City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
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United States
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Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
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United States
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Research Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
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Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Research Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Research Site
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Research Site
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Research Site
City
College Point
State/Province
New York
ZIP/Postal Code
11356
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
Rosedale
State/Province
New York
ZIP/Postal Code
11422
Country
United States
Facility Name
Research Site
City
The Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Research Site
City
Yonkers
State/Province
New York
ZIP/Postal Code
10704
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Research Site
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
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
45267
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Research Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Research Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Research Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37408
Country
United States
Facility Name
Research Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
Research Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Facility Name
Research Site
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
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
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Research Site
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116
Country
United States
Facility Name
Research Site
City
Bluefield
State/Province
West Virginia
ZIP/Postal Code
24701
Country
United States
Facility Name
Research Site
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Research Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Research Site
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Research Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Research Site
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Research Site
City
Prahan
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Research Site
City
Feldkirch
ZIP/Postal Code
6807
Country
Austria
Facility Name
Research Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1220
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
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1020
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
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Research Site
City
Tournai
ZIP/Postal Code
7500
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
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Research Site
City
Novy Jicin
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Research Site
City
Plzen
ZIP/Postal Code
301 00
Country
Czechia
Facility Name
Research Site
City
Praha 4 - Nusle
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
140 21
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
Usti nad Orlici
ZIP/Postal Code
562 18
Country
Czechia
Facility Name
Research Site
City
Fredericia
ZIP/Postal Code
7000
Country
Denmark
Facility Name
Research Site
City
København
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Research Site
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Research Site
City
La Tronche cedex
ZIP/Postal Code
38701
Country
France
Facility Name
Research Site
City
Lille Cedex
ZIP/Postal Code
59800
Country
France
Facility Name
Research Site
City
Marseille
ZIP/Postal Code
13253
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
Reims Cedex
ZIP/Postal Code
51092
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
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
12053
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
22297
Country
Germany
Facility Name
Research Site
City
Langenhagen
ZIP/Postal Code
30853
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
Villingen-Schwenningen
ZIP/Postal Code
78052
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
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
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Research Site
City
Esztergom
ZIP/Postal Code
2500
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
Miskolc
ZIP/Postal Code
3526
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
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Research Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Research Site
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Research Site
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Research Site
City
Ancona
ZIP/Postal Code
60126
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
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1001
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
Ukmerge
ZIP/Postal Code
20184
Country
Lithuania
Facility Name
Research Site
City
Rotterdam
ZIP/Postal Code
3079 DZ
Country
Netherlands
Facility Name
Research Site
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Research Site
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Research Site
City
Golub-Dobrzyn
ZIP/Postal Code
87-400
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-027
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90-153
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
Warszawa
ZIP/Postal Code
02-097
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
Zamosc
ZIP/Postal Code
87-100
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
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
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
196247
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
Saint-Petersburg
ZIP/Postal Code
195257
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
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
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
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
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Research Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Karlstad
ZIP/Postal Code
651 85
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
118 67
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Research Site
City
Trollhättan
ZIP/Postal Code
467 85
Country
Sweden
Facility Name
Research Site
City
Uppsala
ZIP/Postal Code
751 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
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
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
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