This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.
This is a multicenter, single-arm, extension study in which adults with secondary hyperparathyroidism currently receiving hemodialysis and previously treated in Amgen studies 20120231 (NCT01785875), 20120334 (NCT01576146), or 20120360 (NCT01896232) will continue to be treated with etelcalcetide until approximately 2.5 years after the first participant was enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
902
Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.
Number of Participants With Adverse Events
A serious adverse event is an AE that met at least 1 of the following criteria: * fatal * life threatening * required in-patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event. The relationship of each AE to study treatment was assessed by the investigator. The following AE grading scale was used: Mild: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required Moderate: Mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalization possible Life-threatening: Extreme limitation in activity, significant assistance required, significant medical intervention/therapy required, hospitalization probable.
Time frame: From the date of first dose of etelcalcetide (in the current study) and up to 30 days after the last dose; median duration of treatment was 563 days.
Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal
The percentage of participants who maintained plasma parathyroid hormone (PTH) levels within the Kidney Disease Improving Global Outcomes (KDIGO) recommended range of not less than 2x the upper limit of normal (ULN) and not greater than 9x the ULN at months 6, 12, and 18, with the ULN based on the reference range of the assay used at the individual clinical site.
Time frame: Months 6, 12, and 18
Percentage of Participants With Serum Phosphorus ≤ the ULN
Percentage of participants with serum phosphorus less than or equal to the upper limit of normal for the assay used.
Time frame: Months 6, 12, and 18
Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL
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Research Site
Birmingham, Alabama, United States
Research Site
Alhambra, California, United States
Research Site
Azusa, California, United States
Research Site
Bakersfield, California, United States
Research Site
Cudahy, California, United States
Research Site
Granada Hills, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Northridge, California, United States
Research Site
Riverside, California, United States
...and 218 more locations
The percentage of participants with serum corrected calcium (cCa) reported for cumulative time intervals from day 1 through months 6, 12, and 18, using the participant's lowest recorded corrected calcium value during the time interval. If serum albumin was less than 4.0 g/dL, serum calcium was corrected according to the following formula: cCa (mg/dL) = total calcium (mg/dL) + (4 - albumin \[g/dL\])\*0.8. If serum albumin was \> 4.0 g/dL no correction was made.
Time frame: From day 1 to months 6, 12, and 18
Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters
The Common Terminology Criteria for Adverse Events (CTCAE) grades for laboratory parameter values were defined based on the upper/lower limit of normal from the local laboratories contracted by the study centers.
Time frame: Baseline to end of treatment; median duration of treatment was 563 days.
Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies
The number of participants who were binding antibody positive post-baseline with a negative or no result at baseline (where baseline for participants previously treated with etelcalcetide is Day 1 of the first study in which they were exposed to etelcalcetide and for participants previously treated with cinacalcet is the ending time point for study 20120360).
Time frame: Baseline and every 6 months (up to 24 months)