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
- -
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
Phase 3
Completed
- Conditions
- Interventions
- First Posted Date
- 2013-02-11
- Last Posted Date
- 2019-08-20
- Lead Sponsor
- Amgen
- Target Recruit Count
- 515
- Registration Number
- NCT01788046
- Locations
- 🇸🇪
Research Site, Uppsala, Sweden
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
Phase 3
Completed
- Conditions
- Interventions
- First Posted Date
- 2013-02-07
- Last Posted Date
- 2019-08-26
- Lead Sponsor
- Amgen
- Target Recruit Count
- 508
- Registration Number
- NCT01785849
- Locations
- 🇬🇧
Research Site, Sheffield, United Kingdom
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
- First Posted Date
- 2013-02-07
- Last Posted Date
- 2019-04-10
- Lead Sponsor
- Amgen
- Target Recruit Count
- 891
- Registration Number
- NCT01785875
- Locations
- 🇬🇧
Research Site, Sheffield, United Kingdom
Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism
- First Posted Date
- 2012-04-12
- Last Posted Date
- 2017-04-13
- Lead Sponsor
- KAI Pharmaceuticals
- Target Recruit Count
- 30
- Registration Number
- NCT01576146
Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
- First Posted Date
- 2011-08-11
- Last Posted Date
- 2017-04-11
- Lead Sponsor
- KAI Pharmaceuticals
- Target Recruit Count
- 37
- Registration Number
- NCT01414114
Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
Phase 2
Completed
- Conditions
- Interventions
- First Posted Date
- 2010-12-06
- Last Posted Date
- 2017-04-13
- Lead Sponsor
- KAI Pharmaceuticals
- Target Recruit Count
- 87
- Registration Number
- NCT01254565
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Interventions
- First Posted Date
- 2010-06-02
- Last Posted Date
- 2017-04-14
- Lead Sponsor
- KAI Pharmaceuticals
- Target Recruit Count
- 32
- Registration Number
- NCT01134549
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
Phase 1
Completed
- Conditions
- Interventions
- First Posted Date
- 2010-06-02
- Last Posted Date
- 2018-01-02
- Lead Sponsor
- KAI Pharmaceuticals
- Target Recruit Count
- 28
- Registration Number
- NCT01134562
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