The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by \> 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
683
Administered intravenously three times per week. The starting dose was 5 mg, titrated up to 15 mg based on serum PTH and corrected calcium levels.
Cinacalcet was administered orally once a day. The starting dose was 30 mg daily, titrated up to 180 mg daily based on serum PTH and corrected calcium levels.
Administered orally once a day.
Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis
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 PTH During the Efficacy Assessment Phase
Time frame: Baseline and the efficacy assessment phase (Weeks 20 to 27, inclusive).
Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase
Time frame: Baseline and the efficacy assessment phase (Week 20 to Week 27)
Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks
Participants completed the Nausea/Vomiting Symptom Assessment (NVSA) questionnaire daily. This questionnaire asked participants to indicate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined) and if they had vomited in the past 24 hours. A day of vomiting or nausea was defined as those where the severity of nausea score was \> 0 or where the episodes of vomiting score was \> 0.
Time frame: First 8 weeks
Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase
Time frame: Baseline and the efficacy assessment phase (weeks 20 - 27)
Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase
Time frame: Efficacy assessment phase (weeks 20 - 27)
Mean Severity of Nausea in the First 8 Weeks
Severity of nausea was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asked participants to rate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined). For each participant, the mean severity of nausea was calculated by averaging all available daily severities (including zeroes) reported in the first 8 weeks.
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Administered intravenously (IV) three times per week.
Research Site
Azusa, California, United States
Research Site
Bakersfield, California, United States
Research Site
Bakersfield, California, United States
Research Site
Chula Vista, California, United States
Research Site
Covina, California, United States
Research Site
Granada Hills, California, United States
Research Site
La Mesa, California, United States
Research Site
La Puente, California, United States
Research Site
Los Angeles, California, United States
Research Site
San Diego, California, United States
...and 172 more locations
Time frame: First 8 weeks
Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks
The number of vomiting episodes was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asks participants on a daily basis how many times they vomited in the past 24 hours. The number of episodes in a week is the sum of all reported daily episodes in the week. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.
Time frame: First 8 weeks