Etelcalcetide
- Generic Name
- Etelcalcetide
- Brand Names
- Parsabiv
- Drug Type
- Small Molecule
- Chemical Formula
- C38H73N21O10S2
- CAS Number
- 1262780-97-1
- Unique Ingredient Identifier
- 60ME133FJB
- Background
Etelcalcetide is a calcimimetic drug for the treatment of secondary hyperparathyroidism in patients undergoing hemodialysis. Etelcalcetide was approved (trade name Parsabiv) for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis in February, 2017.
- Indication
Etelcalcetide is a calcium-sensing receptor agonist indicated for:
Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
- Associated Conditions
- Secondary Hyperparathyroidism (SHPT)
- Associated Therapies
- -
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
- First Posted Date
- 2019-05-31
- Last Posted Date
- 2024-12-02
- Lead Sponsor
- Amgen
- Target Recruit Count
- 24
- Registration Number
- NCT03969329
- Locations
- 🇬🇧
Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
🇧🇪Universitair Ziekenhuis Gent, Gent, Belgium
🇨🇿Fakultni nemocnice v Motole, Praha 5, Czechia
The Effect of Etelcalcetide on CKD-MBD
- Conditions
- Interventions
- First Posted Date
- 2019-05-23
- Last Posted Date
- 2023-09-21
- Lead Sponsor
- Thomas Nickolas, MD MS
- Target Recruit Count
- 22
- Registration Number
- NCT03960437
- Locations
- 🇺🇸
Columbia University Irving Medical Center, New York, New York, United States
A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients
- First Posted Date
- 2019-01-07
- Last Posted Date
- 2022-03-23
- Lead Sponsor
- Prim. Priv. Doz. Dr. Daniel Cejka
- Target Recruit Count
- 37
- Registration Number
- NCT03795558
- Locations
- 🇦🇹
Ordensklinikum Linz GmbH Elisabethinen, Linz, Upper Austria, Austria
A Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
- Conditions
- Interventions
- First Posted Date
- 2018-08-16
- Last Posted Date
- 2024-12-13
- Lead Sponsor
- Amgen
- Target Recruit Count
- 56
- Registration Number
- NCT03633708
- Locations
- 🇷🇺
SSBHI Children's City Multidisciplinary Clinical Specialized Center of High Medical Te, Saint Petersburg, Russian Federation
🇺🇸Childrens Hospital of Los Angeles, Los Angeles, California, United States
🇺🇸Childrens Hospital Colorado, Aurora, Colorado, United States
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
- Conditions
- Interventions
- First Posted Date
- 2017-10-03
- Last Posted Date
- 2021-04-30
- Lead Sponsor
- Amgen
- Target Recruit Count
- 637
- Registration Number
- NCT03299244
- Locations
- 🇨🇳
Research Site, Taoyuan, Taiwan
A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416
- Conditions
- Interventions
- First Posted Date
- 2017-09-14
- Last Posted Date
- 2020-02-10
- Lead Sponsor
- Amgen
- Target Recruit Count
- 33
- Registration Number
- NCT03283098
- Locations
- 🇨🇳
Research Site, Shanghai, Shanghai, China
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
- Conditions
- Interventions
- First Posted Date
- 2016-07-14
- Last Posted Date
- 2019-07-10
- Lead Sponsor
- Amgen
- Target Recruit Count
- 11
- Registration Number
- NCT02833857
- Locations
- 🇬🇧
Research Site, London, United Kingdom
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
- First Posted Date
- 2014-04-02
- Last Posted Date
- 2017-11-17
- Lead Sponsor
- Amgen
- Target Recruit Count
- 902
- Registration Number
- NCT02102204
- Locations
- 🇹🇷
Research Site, Izmir, Turkey
Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
- First Posted Date
- 2013-08-30
- Last Posted Date
- 2018-10-17
- Lead Sponsor
- Amgen
- Target Recruit Count
- 158
- Registration Number
- NCT01932970
- Locations
- 🇺🇸
Research Site, Hampton, Virginia, United States
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
- Conditions
- Interventions
- First Posted Date
- 2013-07-11
- Last Posted Date
- 2019-07-18
- Lead Sponsor
- Amgen
- Target Recruit Count
- 683
- Registration Number
- NCT01896232
- Locations
- 🇹🇷
Research Site, Izmir, Turkey
Drug Development Updates
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