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
Who is this study for? Pediatric patients with secondary hyperparathyroidism and chronic kidney disease on hemodialysis
What treatments are being studied? Etelcalcetide
Status: Recruiting
Location: See all (43) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a Phase 3 Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:
• Age of 28 days or older and less than 18 years
• Dry weight ≥ 7 kg during screening.
• Diagnosed with CKD and SHPT undergoing hemodialysis at the time of screening.
• Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values ≥ 400 pg/mL (42 pmol/L) during screening, on separate days and within 2 weeks of enrolment.
• Serum cCa value ≥ 9.0 mg/dL (2.25 mmol/L) for subjects ≥ 2 years of age and older and serum cCa value ≥ 9.6 mg/dL (2.4 mmol/L) for subjects 28 days to \< 2 years of age obtained from the central laboratory during screening.
• Dialysate Ca level ≥ 2.5 mEq/L during screening for at least 4 weeks prior to screening and throughout the duration of the study.
• No more than a maximum prescribed dose change of 50% for active vitamin D sterols/phosphate binders/Ca supplements within the 2 weeks prior to screening assessments and remain stable.
• SHPT not due to vitamin D deficiency, per investigator assessment.
Locations
United States
California
Childrens Hospital of Los Angeles
RECRUITING
Los Angeles
Colorado
Childrens Hospital Colorado
TERMINATED
Aurora
Missouri
Childrens Mercy Hospital
RECRUITING
Kansas City
New York
Mount Sinai Kidney Center - B1 Renal Treatment
COMPLETED
New York
Ohio
Cincinnati Childrens Hospital Medical Center
COMPLETED
Cincinnati
Cleveland Clinic Foundation
RECRUITING
Cleveland
Oklahoma
The Childrens Hospital at Oklahoma University Medical Center
COMPLETED
Oklahoma City
Pennsylvania
Childrens Hospital of Philadelphia
RECRUITING
Philadelphia
Texas
Childrens Medical Center Dallas
TERMINATED
Dallas
Utah
Primary Childrens Hospital Outpatient Services
RECRUITING
Salt Lake City
Other Locations
Argentina
Fresenius Escobar
TERMINATED
Belén De Escobar
Hospital Italiano
RECRUITING
Cuidad Autonoma De Buenos Aires
Centro Infantil Del Rinon
RECRUITING
San Miguel De Tucumán
India
Manipal Hospital
RECRUITING
Bangalore
KLES Dr Prabhakar Kore Hospital and Medical Research Centre
RECRUITING
Belagavi
NRS Medical College and Hospital
RECRUITING
Kolkata
All India Institute of Medical Sciences
RECRUITING
New Delhi
Fortis Flt Lt Rajan Dhall Hospital
RECRUITING
New Delhi
Sir Ganga Ram Hospital
RECRUITING
New Delhi
Malaysia
Hospital Raja Perempuan Zainab II
TERMINATED
Kota Bharu
Hospital Wanita Dan Kanak-Kanak Kuala Lumpur
TERMINATED
Kuala Lumpur
Hospital TuanKu Jaafar
TERMINATED
Seremban
Republic of Korea
Asan Medical Center
TERMINATED
Seoul
Seoul National University Hospital
TERMINATED
Seoul
Pusan National University Yangsan Hospital
TERMINATED
Yangsan-si, Gyeongsangnam-do
Russian Federation
SBHI Pediatrics city clinical hospital of Saint Vladimir
TERMINATED
Moscow
SBHI Children's City Multidisciplinary Clinical Specialized Center of High Medical Technologies
RECRUITING
Saint Petersburg
State Budgetary Healthcare Institution Samara Regional Clinical Hospital na V D Seredavin
TERMINATED
Samara
Singapore
National University Hospital
RECRUITING
Singapore
Taiwan
Kaohsiung Veterans General Hospital
RECRUITING
Kaohsiung City
National Cheng Kung University Hospital
TERMINATED
Tainan City
National Taiwan University Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
Turkey
Ankara Bilkent Sehir Hastanesi
RECRUITING
Ankara
Baskent Universitesi Ankara Hastanesi
RECRUITING
Ankara
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
RECRUITING
Ankara
Hacettepe Universitesi Tip Fakultesi Hastanesi
RECRUITING
Ankara
Firat Universitesi Hastanesi
RECRUITING
Elâzığ
Istanbul Universitesi Cerrahpasa Tip Fakultesi
RECRUITING
Istanbul
Marmara Universitesi Tip Fakultesi Hastanesi
RECRUITING
Istanbul
Ege Universitesi Tip Fakultesi Hastanesi
RECRUITING
Izmir
Erciyes Universitesi Tip Fakultesi Hastanesi
RECRUITING
Kayseri
Ukraine
National Childrens Specializated Hospital Okhmadit
TERMINATED
Kyiv
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date:2019-04-29
Estimated Completion Date:2029-01-31
Participants
Target number of participants:56
Treatments
Experimental: Etelcalcetide
Randomized in a 3:1 ratio to receive etelcalcetide in addition to standard of care
Active_comparator: Control
Randomized in a 3:1 ratio to receive etelcalcetide in addition standard of care alone (control arm)