Spots Global Cancer Trial Database for A Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
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Trial Identification
Brief Title: A Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Official Title: Phase 3, Randomized, Open-label, Controlled, Multiple Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 Days to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis
Study ID: NCT03633708
Interventions
Study Description
Brief Summary: This is a Phase 3 Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Detailed Description: SHPT is a common and serious co-morbidity that develops relatively early in the course of CKD, worsens with declining kidney function, and is associated with serious complications in children on dialysis. Children on dialysis experience a wide spectrum of bone abnormalities and growth retardation, in addition to increased risk for cardiovascular morbidity and mortality that manifests early in their adulthood. Traditional therapies for SHPT (eg, vitamin D sterols) are widely used in the pediatric dialysis population, and have the potential to aggravate complications of the disease by increasing serum calcium (Ca), serum phosphorus, and serum Ca times serum phosphorus product. Etelcalcetide has been shown to be safe and efficacious in treating adult CKD patients with SHPT by simultaneously controlling intact parathyroid hormone (iPTH), Ca, and phosphorus and has recently been approved for use in adult patients with SHPT treated with hemodialysis in both the United States and Europe. Although no previous studies have been conducted in pediatric patients with etelcalcetide (one single dose pharmacokinetic \[PK\] study is currently ongoing),Amgen anticipates minimal to moderate risk with a possibility of direct benefit to the pediatric subjects (age 28 days to 18 years) in this study. The burden of complications of SHPT in the pediatric dialysis population and the limitations of current standard therapy, underscore the need for studies of etelcalcetide in these patients to address this unmet medical need and inform the pediatric nephrology community of the potential use of etelcalcetide in children on hemodialysis with critical safety and efficacy data.
Eligibility
Minimum Age: 0 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Childrens Hospital of Los Angeles, Los Angeles, California, United States
Childrens Hospital Colorado, Aurora, Colorado, United States
Childrens Mercy Hospital, Kansas City, Missouri, United States
Mount Sinai Kidney Center - B1 Renal Treatment, New York, New York, United States
Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
The Childrens Hospital at Oklahoma University Medical Center, Oklahoma City, Oklahoma, United States
Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Childrens Medical Center Dallas, Dallas, Texas, United States
Primary Childrens Hospital Outpatient Services, Salt Lake City, Utah, United States
Hospital Italiano, Cuidad Autonoma de Buenos Aires, Buenos Aires, Argentina
Fresenius Escobar, Escobar, Buenos Aires, Argentina
Centro Infantil Del Rinon, San Miguel de Tucuman, Tucuman, Argentina
Fortis Flt Lt Rajan Dhall Hospital, New Delhi, Delhi, India
All India Institute of Medical Sciences, New Delhi, Delhi, India
Sir Ganga Ram Hospital, New Delhi, Delhi, India
Manipal Hospital, Bangalore, Karnataka, India
KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Belagavi, Karnataka, India
NRS Medical College and Hospital, Kolkata, West Bengal, India
Asan Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Pusan National University Yangsan Hospital, Yangsan-si, Gyeongsangnam-do, , Korea, Republic of
Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan, Malaysia
Hospital TuanKu Jaafar, Seremban, Negri Sembilan, Malaysia
Hospital Wanita Dan Kanak-Kanak Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia
SBHI Pediatrics city clinical hospital of Saint Vladimir, Moscow, , Russian Federation
Municipal Children Hospital 1, Saint Petersburg, , Russian Federation
State Budgetary Healthcare Institution Samara Regional Clinical Hospital na V D Seredavin, Samara, , Russian Federation
National University Hospital, Singapore, , Singapore
Kaohsiung Veterans General Hospital, Kaohsiung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital, Taoyuan, , Taiwan
Hacettepe Universitesi Tip Fakultesi Hastanesi, Ankara, , Turkey
Baskent Universitesi Ankara Hastanesi, Ankara, , Turkey
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi, Ankara, , Turkey
Ankara Bilkent Sehir Hastanesi, Ankara, , Turkey
Firat Universitesi Hastanesi, Elazig, , Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi, Istanbul, , Turkey
Marmara Universitesi Tip Fakultesi Hastanesi, Istanbul, , Turkey
Ege Universitesi Tip Fakultesi Hastanesi, Izmir, , Turkey
Erciyes Universitesi Tip Fakultesi Hastanesi, Kayseri, , Turkey
National Childrens Specializated Hospital Okhmadit, Kyiv, , Ukraine
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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