Back to resultsOpen-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
Primary Purpose
Secondary Hyperparathyroidism
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Etelcalcetide
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Clinical Trial, Phase 2, Renal Dialysis, Secondary Hyperparathyroidism, Chronic kidney disease-mineral and bone disorder, Parathyroid hormone
Eligibility Criteria
Inclusion Criteria:
- Subject provides written informed consent.
- Subject completed the 12 week treatment phase in the parent study study 20120331 ( KAI-4169-005; NCT01414114).
Exclusion Criteria:
- Subject pregnant or nursing
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Etelcalcetide
Arm Description
Participants 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.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Secondary Outcome Measures
Percent Change From Baseline in Parathyroid Hormone
Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of etelcalcetide in the parent study (20120331).
The week numbering for this study continued from the parent study 20120331 hence the first measurement for all parameters in the extension study started at week 13.
Percent Change From Baseline in Serum Corrected Calcium
Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331).
The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13.
Percent Change From Baseline in Serum Phosphorus
Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331).
The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01576146
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated early to allow subjects to roll over to study NCT02102204.
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 1, 2014 (Actual)
Study Completion Date
May 1, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KAI Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
Keywords
Clinical Trial, Phase 2, Renal Dialysis, Secondary Hyperparathyroidism, Chronic kidney disease-mineral and bone disorder, Parathyroid hormone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etelcalcetide
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Drug
Intervention Name(s)
Etelcalcetide
Other Intervention Name(s)
KAI-4169, AMG 416, Parsabiv™
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
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 Outcome Measure Information:
Title
Percent Change From Baseline in Parathyroid Hormone
Description
Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of etelcalcetide in the parent study (20120331).
The week numbering for this study continued from the parent study 20120331 hence the first measurement for all parameters in the extension study started at week 13.
Time Frame
Baseline (of the parent study 20120331) and Weeks 13, 26 and 52
Title
Percent Change From Baseline in Serum Corrected Calcium
Description
Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331).
The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13.
Time Frame
Baseline and Weeks 13, 26 and 52
Title
Percent Change From Baseline in Serum Phosphorus
Description
Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331).
The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13.
Time Frame
Baseline and Weeks 13, 26 and 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject provides written informed consent.
Subject completed the 12 week treatment phase in the parent study study 20120331 ( KAI-4169-005; NCT01414114).
Exclusion Criteria:
Subject pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M D
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
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
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