The primary objective is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum intact parathyroid hormone (PTH) levels by \> 30% from baseline among participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
637
Administered intravenously three times per week.
Cinacalcet administered orally once a day.
Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis
Predialysis intact parathyroid hormone (iPTH) levels were measured by a central laboratory.
Time frame: Baseline and the efficacy assessment phase (EAP; defined as weeks 20 to 27, inclusive).
Percentage of Participants With > 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase
Predialysis intact parathyroid hormone levels were measured by a central laboratory.
Time frame: Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive).
Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis
Predialysis intact parathyroid hormone levels were measured by a central laboratory.
Time frame: Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive)
Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase
Predialysis corrected calcium was measured by a central laboratory.
Time frame: Baseline and the efficacy assessment phase (weeks 20 - 27, inclusive)
Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase
Predialysis serum phosphorus was measured by a central laboratory.
Time frame: Efficacy assessment phase (weeks 20 - 27, inclusive)
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