| Outcome Measures: |
Primary: Pharmacokinetic (PK) Parameter: Time to Maximum Drug Concentration (Tmax) of Plasma Etelcalcetide on Days 1 and 27, Tmax is the time to maximum drug concentration of plasma etelcalcetide after dosing on Days 1 and 27., Days 1 and 27; PK blood sampling predialysis, and at 10, 30, 60, 90 min postdose, as well as on Day 2 and 28 between 18 and 30 hours after study drug administration|PK: Maximum Observed Drug Concentration (Cmax) of Plasma Etelcalcetide on Days 1 and 27, Cmax was defined as the maximum observed plasma drug concentration measured between the time of drug administration to the beginning of the next dialysis session., Days 1 and 27; PK blood sampling predialysis, and at 10, 30, 60, 90 min postdose, as well as on Day 2 and 28 between 18 and 30 hours after study drug administration|Pharmacokinetic (PK) Parameter: Area Under the Curve From Time Zero to the Beginning of the Subsequent Hemodialysis Treatment (AUClast) of Plasma Etelcalcetide on Days 1 and 27, AUClast was specifically defined in this study as the area under the concentration time curve measured from the time of drug administration to the beginning of the next dialysis session, following the first and last dose., Days 1 and 27; PK blood sampling predialysis, and up to 44-50 hour postdose.at 10, 30, 60, 90 min postdose: Day 2 and 28 between 18 and 30 hours after study drug administration; Day 3 (predialysis) + Day 29|Pharmacokinetic (PK) Parameter: Accumulation Ratio Comparing Days 1 and 27, Accumulation ratio, calculated as AUClast day 27/AUClast day 1., Days 1 and 27; PK blood sampling predialysis, and up to 44-50 hour postdose.at 10, 30, 60, 90 min postdose: Day 2 and 28 between 18 and 30 hours after study drug administration; Day 3 (predialysis) + Day 29 | Secondary: Participants With Treatment-Emergent Adverse Events (TEAEs), The severity of each adverse event was assessed using the NCI-CTCAE Version 4.0 according to the following: * Grade 1 - Mild: Asymptomatic or mild symptoms; intervention not indicated * Grade 2 - Moderate: Minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) * Grade 3 - Severe: Medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL * Grade 4 - Life-threatening * Grade 5 - Fatal. A serious AE is an AE that met one or more of the following criteria: * Death * Life-threatening * Required inpatient hospitalization or prolongation of an existing hospitalization * Resulted in persistent or significant disability/incapacity * A congenital anomaly/birth defect * Important medical events that required medical or surgical intervention to prevent one of the outcomes above., Day 1 up to Day 55 (end of study)|Participants With Treatment-Emergent Adverse Events (TEAEs) of Interest, Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. Narrow search criteria used for both standardized MedDRA queries (SMQ) and events of interest (EOI). One preferred term (PT) could match multiple EOIs. Infusion Reaction EOI counts included only those events which had onset day coinciding with study medication infusion and resolved on the same day or the day after onset., Day 1 up to Day 55 (end of study)|Participants With Clinically-Significant Changes in Electrocardiograms (ECGs) From Baseline to End of Study, Count of participants who exhibited a clinically significant change in the results of their 12-lead electrocardiograms (ECG) when comparing baseline to end of study ECGs., Baseline is Day -2; End of Study is Day 55|Change From Baseline to End of Study in Weight, Change from baseline in weight measured at visit., Day 1 up to Day 55|Change From Baseline to End of Study in Systolic and Diastolic Blood Pressures, Participants remained seated for at least 10 minutes prior to measurement of predialysis heart rate and blood pressure., Baseline Day 1 prior to dialysis; End of Study is Day 55|Baseline and Change From Baseline to End of Study in Heart Rate, Participants remained seated for at least 10 minutes prior to measurement of predialysis heart rate and blood pressure., Baseline Day 1 prior to dialysis; End of Study is Day 55|Change From Baseline to End of Study in Calcium, Calcium was tested at a central laboratory., Baseline is Day 1 prior to dialysis; End of Study is Day 55|Change From Baseline to End of Study in Corrected Calcium (cCa), Total serum calcium was corrected if the serum albumin was \< 4 g/dL or 40 g/L, otherwise cCa equals total serum calcium. The correction formula was: Corrected calcium (mg/dL) = Total calcium (mg/dL) + (4 - albumin \[g/dL\]) \* 0.8, Baseline is the average of Day -2 and Day 1 prior to dialysis; End of Study is Day 55|Participants With Low Corrected Calcium (cCA) By Category, The lowest cCA value for each participant is reported. Total serum calcium was corrected if the serum albumin was \< 4 g/dL or 40 g/L, otherwise cCa equals total serum calcium. The correction formula was: Corrected calcium (mg/dL) = Total calcium (mg/dL) + (4 - albumin \[g/dL\]) \* 0.8, Timeframes: Days 8, 15, 22, 27, 29, 34, 41, 55|Baseline and Change From Baseline to End of Study in Serum Albumin, Serum albumin was tested at a central laboratory., Baseline is the average of Day -2 and Day 1 prior to dialysis; End of Study is Day 55|Change From Baseline to End of Study in Serum Phosphorus, Serum phosphorus was tested at a central laboratory., Baseline is Day 1 prior to dialysis; End of Study is Day 55|Participants With Anti-etelcalcetide Antibody at Baseline and Postbaseline, Participants with positive titers for antibodies to etelcalcetide could be asked to return to the clinical research unit to provide additional serum samples., Baseline: Day 1 prior to dialysis. Postbaseline: Days 29 and 55 prior to dialysis
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| Locations: |
Research Site, Beijing, Beijing, 100044, China|Research Site, Nanjing, Jiangsu, 210029, China|Research Site, Shanghai, Shanghai, 200032, China|Research Site, Shanghai, Shanghai, 200040, China|Research Site, Shanghai, Shanghai, 200127, China
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