- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01576146
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Etelcalcetide
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline in Parathyroid Hormone
Time Frame: Baseline (of the parent study 20120331) and Weeks 13, 26 and 52
|
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. |
Baseline (of the parent study 20120331) and Weeks 13, 26 and 52
|
Percent Change From Baseline in Serum Corrected Calcium
Time Frame: Baseline and Weeks 13, 26 and 52
|
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. |
Baseline and Weeks 13, 26 and 52
|
Percent Change From Baseline in Serum Phosphorus
Time Frame: Baseline and Weeks 13, 26 and 52
|
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. |
Baseline and Weeks 13, 26 and 52
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: M D, Amgen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Neoplasms
- Kidney Diseases
- Urologic Diseases
- Endocrine System Diseases
- Nutrition Disorders
- Musculoskeletal Diseases
- Parathyroid Diseases
- Neoplastic Processes
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Bone Diseases
- Bone Diseases, Metabolic
- Calcium Metabolism Disorders
- Rickets
- Vitamin D Deficiency
- Hyperparathyroidism
- Neoplasm Metastasis
- Hyperparathyroidism, Secondary
- Chronic Kidney Disease-Mineral and Bone Disorder
Other Study ID Numbers
- KAI-4169-005-01
- 20120334 (Other Identifier: Amgen, Inc)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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