| Outcome Measures: |
Primary: Proportion of participants with ≥ 30% reduction from baseline in intact parathyroid hormone (iPTH) level during the efficacy assessment phase (EAP), Achievement of at least a 30% reduction from baseline in mean iPTH during the EAP (defined as weeks 20 through 27)., Baseline and Weeks 20-27 | Secondary: Maximum serum concentration (Cmax) of etelcalcetide, Cmax will be collected and reported for the etelcalcetide arm only., 10-30 minutes post dose on Day 1 and 10-30 minutes post dose on Weeks 5, 9, 13, 17, and 21|Minimum serum concentration (Cmin) of etelcalcetide, Cmin will be collected and reported for the etelcalcetide arm only., 10-30 minutes post dose on Day 1 and 10-30 minutes post dose on Weeks 5, 9, 13, 17, and 21|Incidence of adverse events, To characterize the safety of etelcalcetide treatment based on adverse events. Nature, frequency, severity, and relationship to treatment of all adverse events, including those of special interest reported during the study., Day 1 to 30 days after last dose of etelcalcetide (up to approximately 30 weeks)|Frequency of hypocalcemia, Occurrence of hypocalcemia at any point in time, assessed by serum chemistry., Up to approximately 30 Weeks|Number of participants with corrected serum calcium levels at any time during the study, Occurrence of corrected serum Ca levels \<8.0 mg/dL (2.0 mmol/L) for subjects 2 to \< 18 years of age and \<8.6 mg/dL (2.15 mmol/L) for subjects 28 days to \<2 years of age during the study., Up to approximately 30 Weeks|Number of participants with serum phosphorous levels below normal for age, Occurrence of serum phosphorous levels below the lower limit of normal for age., Up to approximately 30 Weeks|Number of participants with predialysis iPTH levels below normal, Occurrence of predialysis iPTH levels below the lower limit of normal for age., Up to approximately 30 Weeks|Change from baseline in systolic blood pressure, To characterize the safety of etelcalcetide treatment based on vital signs., Week -2, Week -1, Day1, and Weeks 4, 8, 12, 16, 20, 24, and 27|Change from baseline in diastolic blood pressure, To characterize the safety of etelcalcetide treatment based on vital signs., Week -2, Week -1, Day1, and Weeks 4, 8, 12, 16, 20, 24, and 27|Change from baseline in heart rate, To characterize the safety of etelcalcetide treatment based on vital signs., Week -2, Week -1, Day1, and Weeks 4, 8, 12, 16, 20, 24, and 27|Change in Tanner Stage, Changes in tanner stage at scheduled visits., Week -2 and Week 27|Change in height, Changes in height at scheduled visits., Day 1 and Week 27|Change in weight, Changes in weight at scheduled visits., Week -2, Day 1, and Week 27|Achievement of ≥ 30% reduction in iPTH from baseline on two consecutive visits, To characterize change in laboratory markers of CKD following etelcalcetide treatment., Up to approximately 30 Weeks|Mean change from baseline in predialysis iPTH, Mean change from baseline in predialysis iPTH during the EAP (defined as weeks 20 through 27)., Baseline and Weeks 20-27|Percentage change from baseline in predialysis iPTH, Percentage change from baseline in predialysis iPTH during the EAP (defined as weeks 20 through 27)., Baseline and Weeks 20-27|Percentage change from baseline in corrected total serum calcium, Percentage change from baseline in corrected total serum calcium during the EAP (defined as weeks 20 through 27)., Baseline and Weeks 20-27|Percentage change from baseline in corrected total serum phosphorous, Percentage change from baseline in corrected total serum phosphorous during the EAP (defined as weeks 20 through 27)., Baseline and Weeks 20-27
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| Locations: |
Childrens Hospital of Los Angeles, Los Angeles, California, 90027, United States|Childrens Hospital Colorado, Aurora, Colorado, 80045, United States|Childrens Mercy Hospital, Kansas City, Missouri, 64108, United States|Mount Sinai Kidney Center - B1 Renal Treatment, New York, New York, 10029, United States|Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio, 45229, United States|Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States|The Childrens Hospital at Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States|Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|Childrens Medical Center Dallas, Dallas, Texas, 75390, United States|Primary Childrens Hospital Outpatient Services, Salt Lake City, Utah, 84113, United States|Hospital Italiano, Cuidad Autonoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina|Fresenius Escobar, Escobar, Buenos Aires, B1625DUG, Argentina|Centro Infantil Del Rinon, San Miguel de Tucuman, Tucuman, 4000, Argentina|Fortis Flt Lt Rajan Dhall Hospital, New Delhi, Delhi, 110 070, India|All India Institute of Medical Sciences, New Delhi, Delhi, 110029, India|Sir Ganga Ram Hospital, New Delhi, Delhi, 110060, India|Manipal Hospital, Bangalore, Karnataka, 560 017, India|KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Belagavi, Karnataka, 590010, India|NRS Medical College and Hospital, Kolkata, West Bengal, 700014, India|Asan Medical Center, Seoul, 05505, Korea, Republic of|Seoul National University Hospital, Seoul, 110-744, Korea, Republic of|Pusan National University Yangsan Hospital, Yangsan-si, Gyeongsangnam-do, 50612, Korea, Republic of|Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan, 15586, Malaysia|Hospital TuanKu Jaafar, Seremban, Negri Sembilan, 70300, Malaysia|Hospital Wanita Dan Kanak-Kanak Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, 50300, Malaysia|SBHI Pediatrics city clinical hospital of Saint Vladimir, Moscow, 107014, Russian Federation|SSBHI Children's City Multidisciplinary Clinical Specialized Center of High Medical Te, Saint Petersburg, 198205, Russian Federation|State Budgetary Healthcare Institution Samara Regional Clinical Hospital na V D Seredavin, Samara, 443095, Russian Federation|National University Hospital, Singapore, 119074, Singapore|Kaohsiung Veterans General Hospital, Kaohsiung, 81362, Taiwan|National Cheng Kung University Hospital, Tainan, 70403, Taiwan|National Taiwan University Hospital, Taipei, 10041, Taiwan|Linkou Chang Gung Memorial Hospital, Taoyuan, 33305, Taiwan|Hacettepe Universitesi Tip Fakultesi Hastanesi, Ankara, 06230, Turkey|Baskent Universitesi Ankara Hastanesi, Ankara, 06490, Turkey|Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi, Ankara, 06500, Turkey|Ankara Bilkent Sehir Hastanesi, Ankara, 06800, Turkey|Firat Universitesi Hastanesi, Elazig, 23200, Turkey|Istanbul Universitesi Cerrahpasa Tip Fakultesi, Istanbul, 34098, Turkey|Marmara Universitesi Tip Fakultesi Hastanesi, Istanbul, 34890, Turkey|Ege Universitesi Tip Fakultesi Hastanesi, Izmir, 35040, Turkey|Erciyes Universitesi Tip Fakultesi Hastanesi, Kayseri, 38039, Turkey|National Childrens Specializated Hospital Okhmadit, Kyiv, 01135, Ukraine
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