Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
A Multicenter, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416
3 other identifiers
interventional
158
1 country
40
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2013
Typical duration for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2013
CompletedFirst Submitted
Initial submission to the registry
August 28, 2013
CompletedFirst Posted
Study publicly available on registry
August 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2017
CompletedResults Posted
Study results publicly available
April 4, 2017
CompletedOctober 17, 2018
September 1, 2018
5 months
August 28, 2013
February 16, 2017
September 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period
4 weeks
Secondary Outcomes (2)
Percent Change From Baseline in Parathyroid Hormone During the Treatment Period
Baseline and weeks 2, 3 and 4
Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period
4 weeks
Other Outcomes (2)
Number of Participants With Adverse Events
From the first dose of study drug up to 30 days after the last dose; 8 weeks
Percentage of Participants With Symptomatic Hypocalcemia During the 4-week Treatment Period
From the first dose of study drug up to 30 days after the last dose; 8 weeks
Study Arms (1)
Etelcalcetide
EXPERIMENTALParticipants 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.
Interventions
Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (40)
Research Site
Alhambra, California, 91801, United States
Research Site
Azusa, California, 91702, United States
Research Site
Bakersfield, California, 93308, United States
Research Site
Chula Vista, California, 91910, United States
Research Site
La Mesa, California, 91942, United States
Research Site
Los Angeles, California, 90022, United States
Research Site
Lynwood, California, 90262, United States
Research Site
Riverside, California, 92505, United States
Research Site
Whittier, California, 90603, United States
Research Site
Arvada, Colorado, 80002, United States
Research Site
North Haven, Connecticut, 06473, United States
Research Site
Coral Springs, Florida, 33071, United States
Research Site
Hollywood, Florida, 33021, United States
Research Site
Miami, Florida, 33150, United States
Research Site
Pembroke Pines, Florida, 33028, United States
Research Site
Pinecrest, Florida, 33156, United States
Research Site
Tampa, Florida, 33614, United States
Research Site
Augusta, Georgia, 30909, United States
Research Site
Evergreen Park, Illinois, 60805, United States
Research Site
Michigan City, Indiana, 46360, United States
Research Site
Baton Rouge, Louisiana, 70808, United States
Research Site
Lafayette, Louisiana, 70506, United States
Research Site
Columbus, Mississippi, 39705, United States
Research Site
Gulfport, Mississippi, 39501, United States
Research Site
Farmington, Missouri, 63640, United States
Research Site
Kansas City, Missouri, 64111, United States
Research Site
St Louis, Missouri, 63136, United States
Research Site
Portsmouth, New Hampshire, 03801, United States
Research Site
Eatontown, New Jersey, 07724, United States
Research Site
College Point, New York, 11356, United States
Research Site
Oklahoma City, Oklahoma, 73116, United States
Research Site
Philadelphia, Pennsylvania, 19106, United States
Research Site
Orangeburg, South Carolina, 29118, United States
Research Site
Arlington, Texas, 76015, United States
Research Site
Greenville, Texas, 75402, United States
Research Site
Houston, Texas, 77004, United States
Research Site
McAllen, Texas, 78503, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Fairfax, Virginia, 22033, United States
Research Site
Hampton, Virginia, 23666, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2013
First Posted
August 30, 2013
Study Start
August 12, 2013
Primary Completion
January 14, 2014
Study Completion
February 14, 2017
Last Updated
October 17, 2018
Results First Posted
April 4, 2017
Record last verified: 2018-09