Back to resultsStudy to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
Primary Purpose
Hyperparathyroidism, Secondary
Status
Completed
Phase
Phase 3
Locations
United States
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), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
Eligibility Criteria
Inclusion Criteria
- Subject is 18 years of age or older at the time of informed consent.
- Subject must be receiving maintenance hemodialysis 3 times weekly for at least 8 weeks.
- Subject must have SHPT as defined by having a mean of 3 consecutive central laboratory screening predialysis serum parathyroid hormone (PTH) values ≥ 200 pg/mL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
- Subject must have a mean of 3 consecutive central laboratory screening predialysis serum corrected calcium (cCa) values ≥ 7.5 mg/dL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
- Subject must be on a stable dose of cinacalcet before screening (defined as no dose change within the 4 weeks prior to screening).
- Other Inclusion Criteria may apply.
Exclusion Criteria
- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
- Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as KAI-4169).
- Subject has known sensitivity to any of the products or components of AMG 416 to be administered during dosing.
- Subject is unwilling to use effective contraception during the study, and for women, up to a period of up to 3 months after the last dose of AMG 416.
- Subject is pregnant or nursing.
- Anticipated or scheduled parathyroidectomy during the study period.
- Subject has received a parathyroidectomy within 6 months prior to dosing.
- Other Exclusion Criteria may apply.
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Etelcalcetide
Arm Description
Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period
Secondary Outcome Measures
Percent Change From Baseline in Parathyroid Hormone During the Treatment Period
Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01932970
Brief Title
Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
Official Title
A Multicenter, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 12, 2013 (Actual)
Primary Completion Date
January 14, 2014 (Actual)
Study Completion Date
February 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etelcalcetide
Arm Type
Experimental
Arm Description
Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Etelcalcetide
Other Intervention Name(s)
KAI 4169, AMG 416, Parsabiv™
Intervention Description
Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.
Primary Outcome Measure Information:
Title
Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Parathyroid Hormone During the Treatment Period
Time Frame
Baseline and weeks 2, 3 and 4
Title
Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Number of Participants With Adverse Events
Time Frame
From the first dose of study drug up to 30 days after the last dose; 8 weeks
Title
Percentage of Participants With Symptomatic Hypocalcemia During the 4-week Treatment Period
Description
Hpocalcemia was used for events of decreased calcium accompanied by clinical signs and symptoms of hypocalcemia.
Time Frame
From the first dose of study drug up to 30 days after the last dose; 8 weeks
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 is 18 years of age or older at the time of informed consent.
Subject must be receiving maintenance hemodialysis 3 times weekly for at least 8 weeks.
Subject must have SHPT as defined by having a mean of 3 consecutive central laboratory screening predialysis serum parathyroid hormone (PTH) values ≥ 200 pg/mL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
Subject must have a mean of 3 consecutive central laboratory screening predialysis serum corrected calcium (cCa) values ≥ 7.5 mg/dL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
Subject must be on a stable dose of cinacalcet before screening (defined as no dose change within the 4 weeks prior to screening).
Other Inclusion Criteria may apply.
Exclusion Criteria
Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as KAI-4169).
Subject has known sensitivity to any of the products or components of AMG 416 to be administered during dosing.
Subject is unwilling to use effective contraception during the study, and for women, up to a period of up to 3 months after the last dose of AMG 416.
Subject is pregnant or nursing.
Anticipated or scheduled parathyroidectomy during the study period.
Subject has received a parathyroidectomy within 6 months prior to dosing.
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
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
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
93308
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
La Mesa
State/Province
California
ZIP/Postal Code
91942
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
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
Facility Name
Research Site
City
Riverside
State/Province
California
ZIP/Postal Code
92505
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
North Haven
State/Province
Connecticut
ZIP/Postal Code
06473
Country
United States
Facility Name
Research Site
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33071
Country
United States
Facility Name
Research Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33150
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
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Research Site
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Research Site
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
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
70506
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
Farmington
State/Province
Missouri
ZIP/Postal Code
63640
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Research Site
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
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
College Point
State/Province
New York
ZIP/Postal Code
11356
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
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Research Site
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Research Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
Texas
ZIP/Postal Code
75402
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Research Site
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
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
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
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
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