This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
891
Administered by bolus injection into the venous line of the dialysis circuit at the end of hemodialysis treatment, and prior to or during rinse-back with each hemodialysis session (ie, 3 times per week).
Number of Participants With Adverse Events (AEs)
Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.
Time frame: From first dose until 30 days after last dose; the treatment period was 52 weeks.
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4
Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated.
Time frame: 52 weeks
Number of Participants Who Developed Anti-etelcalcetide Antibodies
A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported.
Time frame: Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit
Change From Baseline in Blood Pressure
Blood pressure (BP) values were taken post-hemodialysis assessments.
Time frame: Baseline and Weeks 24 and 48
Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase
The efficacy assessment phase (EAP) is defined as the last 6 weeks before ending treatment, which was only for participants who completed a minimum of 8 weeks of treatment with etelcalcetide. If multiple assessments were available during the EAP, values were averaged.
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Research Site
Birmingham, Alabama, United States
Research Site
Pine Bluff, Arkansas, United States
Research Site
Azusa, California, United States
Research Site
Bakersfield, California, United States
Research Site
Chula Vista, California, United States
Research Site
Cudahy, California, United States
Research Site
Fairfield, California, United States
Research Site
Glendale, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
...and 198 more locations
Time frame: Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment)
Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12
The efficacy assessment phase at 12 months (EAP12) was defined as the period from week 46 to 53 (inclusive). If multiple assessments were available during the EAP12, values were averaged.
Time frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percentage of Participants With PTH ≤ 300 pg/mL During the EAP
Time frame: Baseline and the efficacy assessment phase
Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12
Time frame: Week 46 to 53
Percent Change From Baseline in Mean PTH During the EAP
Time frame: Baseline and the efficacy assessment phase
Percent Change From Baseline in Mean PTH During the EAP12
Time frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percent Change From Baseline in Mean Corrected Calcium During the EAP
Time frame: Baseline and the efficacy assessment phase
Percent Change From Baseline in Mean Corrected Calcium During the EAP12
Time frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP
Time frame: Baseline and the efficacy assessment phase
Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12
Time frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percent Change From Baseline in Mean Phosphorus During the EAP
Time frame: Baseline and the efficacy assessment phase
Percent Change From Baseline in Mean Phosphorus During the EAP12
Time frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)