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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)
Clinical Trials
Related News

MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease

Phase 2
Recruiting
Conditions
Secondary Hyperparathyroidism (SHPT) in Subjects with Chronic Kidney Disease (CKD) on Hemodialysis
Interventions
Drug: Placebo
First Posted Date
2024-11-15
Last Posted Date
2025-03-26
Lead Sponsor
Shaanxi Micot Technology Limited Company
Target Recruit Count
112
Registration Number
NCT06690242
Locations
🇨🇳

First Affiliated Hospital College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China

A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis

Phase 3
Recruiting
Conditions
Secondary Hyperparathyroidism
Interventions
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

and more 20 locations

The Effect of Etelcalcetide on CKD-MBD

Phase 2
Completed
Conditions
Vascular Calcification
Hyperparathyroidism; Secondary, Renal
Chronic Kidney Disease Mineral and Bone Disorder
Renal Osteodystrophy
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

Phase 2
Completed
Conditions
End Stage Renal Disease
Interventions
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

Phase 3
Recruiting
Conditions
Secondary Hyperparathyroidism
Chronic Kidney Disease
Interventions
First Posted Date
2018-08-16
Last Posted Date
2025-05-08
Lead Sponsor
Amgen
Target Recruit Count
56
Registration Number
NCT03633708
Locations
🇹🇷

Firat Universitesi Hastanesi, Elazig, Turkey

🇺🇸

Childrens Hospital of Los Angeles, Los Angeles, California, United States

🇺🇸

Childrens Hospital Colorado, Aurora, Colorado, United States

and more 40 locations

Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)

Phase 3
Completed
Conditions
Secondary Hyperparathyroidism
Chronic Kidney Disease
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

Phase 1
Completed
Conditions
Secondary Hyperparathyroidism
Interventions
Drug: Placebo
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

Phase 1
Completed
Conditions
Chronic Kidney Disease, Secondary Hyperparathyroidism
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

Phase 3
Completed
Conditions
Hyperparathyroidism, Secondary
Interventions
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

Phase 3
Completed
Conditions
Hyperparathyroidism, Secondary
Interventions
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

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