Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease 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 compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) 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 must be receiving hemodialysis 3 times weekly for at least 3 months Subject agrees to not participate in another study of an investigational agent during the study. 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 (also referred to as KAI-4169). Subject has received cinacalcet within the 4 weeks prior to screening labs (treatment with cinacalcet is prohibited during the study). 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. 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 |
| --- | --- |
| Experimental: Etelcalcetide<br>Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times a week, 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 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: KAI-4169;|
| 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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a > 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 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