Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

Study Overview
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Brief Summary
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This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

Conditions
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Hyperparathyroidism, Secondary

Intervention / Treatment
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* Drug: Etelcalcetide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject understands the study procedures and agrees to participate in the study by giving written informed consent. Subject is 18 years of age or older. Subject agrees to not participate in another study of an investigational agent during the study. Subject must be receiving hemodialysis 3 times weekly for at least 3 months Other Inclusion Criteria may apply Exclusion Criteria: Currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening. Other investigational procedures while participating in this study are excluded. Anticipated or scheduled parathyroidectomy during the study period. Subject has received a parathyroidectomy within 3 months prior to dosing. Anticipated or scheduled kidney transplant during the study period. Subject has known sensitivity to any of the products or components to be administered during dosing. Subject has participated in a prior clinical trial of AMG 416 Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator. Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject. Other Exclusion Criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. | Drug: Placebo<br>* Administered intravenously (IV) three times per week.<br>|
| Experimental: Etelcalcetide<br>Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks. | Drug: Etelcalcetide<br>* Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at weeks 5, 9, 13, and 17 (4-week intervals) by 2.5 mg or 5 mg on the basis of the predialysis parathyroid hormone and corrected calcium concentrations obtained in the prior week. The minimum dose was 2.5 mg and the maximum dose was 15 mg.<br>* Other names: AMG 416;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase | Participants who did not have any scheduled assessments during the EAP were considered non-responders. | Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase | Participants who had no scheduled assessments during the EAP were considered non-responders. | Baseline and the efficacy assessment phase (Week 20 to Week 27) | 
| Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase |  | Baseline and the Efficacy Assessment Phase (Week 20 to Week 27) | 
| Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase |  | Baseline and the efficacy assessment phase (Week 20 to Week 27) | 
| Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase |  | Baseline and the efficacy assessment phase (Week 20 to Week 27) | 
| Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase |  | Baseline and the efficacy assessment phase (Week 20 to Week 27) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism