Study Stopped
Study was terminated early to allow subjects to roll over to study NCT02102204.
Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism
A Multicenter Open-label Extension Study to Assess the Long-term Safety and Efficacy of KAI-4169 (Also Known as AMG 416) in the Treatment of Chronic Kidney Disease-Mineral and Bone Disorder in Patients With Secondary Hyperparathyroidism
2 other identifiers
interventional
30
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis who had completed 12 weeks of treatment with etelcalcetide in parent study 20120331 (KAI-4169-005; NCT01414114).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 5, 2012
CompletedFirst Posted
Study publicly available on registry
April 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
April 13, 2017
CompletedApril 13, 2017
March 1, 2017
2.2 years
April 5, 2012
March 1, 2017
March 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events
From the first dose of study drug in the parent study (20120331) through 30 days after the last dose in the extension study; actual median duration of treatment was 439 days.
Secondary Outcomes (3)
Percent Change From Baseline in Parathyroid Hormone
Baseline (of the parent study 20120331) and Weeks 13, 26 and 52
Percent Change From Baseline in Serum Corrected Calcium
Baseline and Weeks 13, 26 and 52
Percent Change From Baseline in Serum Phosphorus
Baseline and Weeks 13, 26 and 52
Study Arms (1)
Etelcalcetide
EXPERIMENTALParticipants received a bolus IV injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
Interventions
Administered as an intravenous bolus three times a week at the end of each hemodialysis session at dosages up to a maximum of 15 mg.
Eligibility Criteria
You may qualify if:
- Subject provides written informed consent.
- Subject completed the 12 week treatment phase in the parent study study 20120331 ( KAI-4169-005; NCT01414114).
You may not qualify if:
- Subject pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen, Inc
Study Officials
- STUDY DIRECTOR
M D
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2012
First Posted
April 12, 2012
Study Start
March 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
April 13, 2017
Results First Posted
April 13, 2017
Record last verified: 2017-03