Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
|ClinicalTrials.gov Identifier: NCT02102204|
Recruitment Status : Completed
First Posted : April 2, 2014
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hyperparathyroidism, Secondary||Drug: Etelcalcetide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||902 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Single-arm Extension Study to Describe the Long-term Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis|
|Actual Study Start Date :||March 25, 2014|
|Primary Completion Date :||November 4, 2016|
|Study Completion Date :||June 26, 2017|
Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.
- Number of Participants With Adverse Events [ 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. ]
A serious adverse event is an AE that met at least 1 of the following criteria:
- 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.
- Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal [ Time Frame: Months 6, 12, and 18 ]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.
- Percentage of Participants With Serum Phosphorus ≤ the ULN [ Time Frame: Months 6, 12, and 18 ]Percentage of participants with serum phosphorus less than or equal to the upper limit of normal for the assay used.
- Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL [ Time Frame: From day 1 to months 6, 12, and 18 ]
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.
- Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters [ Time Frame: Baseline to end of treatment; median duration of treatment was 563 days. ]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.
- Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies [ Time Frame: Baseline and every 6 months (up to 24 months) ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102204
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