Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide

Study Overview
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Brief Summary
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This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).

Official Title
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A Multicenter, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416

Conditions
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Hyperparathyroidism, Secondary

Intervention / Treatment
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* Drug: Etelcalcetide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subject is 18 years of age or older at the time of informed consent. Subject must be receiving maintenance hemodialysis 3 times weekly for at least 8 weeks. Subject must have SHPT as defined by having a mean of 3 consecutive central laboratory screening predialysis serum parathyroid hormone (PTH) values ≥ 200 pg/mL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet. Subject must have a mean of 3 consecutive central laboratory screening predialysis serum corrected calcium (cCa) values ≥ 7.5 mg/dL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet. Subject must be on a stable dose of cinacalcet before screening (defined as no dose change within the 4 weeks prior to screening). Other Inclusion Criteria may apply. Exclusion Criteria Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s). Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as KAI-4169). Subject has known sensitivity to any of the products or components of AMG 416 to be administered during dosing. Subject is unwilling to use effective contraception during the study, and for women, up to a period of up to 3 months after the last dose of AMG 416. Subject is pregnant or nursing. Anticipated or scheduled parathyroidectomy during the study period. Subject has received a parathyroidectomy within 6 months prior to dosing. 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etelcalcetide<br>Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks. | Drug: Etelcalcetide<br>* Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.<br>* Other names: Parsabiv™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Parathyroid Hormone During the Treatment Period |  | Baseline and weeks 2, 3 and 4 | 
| Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period |  | 4 weeks | 

 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