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Generated: August 21, 2019

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CLINICAL TRIALS PROFILE FOR ETELCALCETIDE

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Clinical Trials for Etelcalcetide

Trial ID Title Status Sponsor Phase Summary
NCT01896232 Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet Completed Amgen Phase 3 The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
NCT02833857 A Single-dose Study in Paediatric Subjects Aged 2 to Less Than 18 Years With (sHPT) Receiving Haemodialysis Not yet recruiting Amgen Phase 1 This is a multicenter, open-label study to evaluate the safety and pharmacokinetics in pediatric subjects with secondary hyperparathyroidism receiving a single dose of AMG 416 at the end of hemodialysis.
NCT03299244 Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian HD Subjects With SHPT Not yet recruiting Amgen Phase 3 To demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum intact parathyroid hormone (PTH) levels by > 30% from baseline among subjects with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
NCT03633708 Study of Etelcalceide in Pediatric Subjects With Secondary Hyperparathyroidism and CKD on Hemodialysis Not yet recruiting Amgen Phase 3 Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
NCT03795558 A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients Not yet recruiting Amgen Phase 2 This is a single-center, prospective, dose-escalation, pilot study in 15 end-stage renal disease patients on chronic hemodialysis with secondary hyperparathyroidism.
>Trial ID >Title >Status >Phase >Summary

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Clinical Trial Conditions for Etelcalcetide

Condition Name

Condition Name for Etelcalcetide
Intervention Trials
Secondary Hyperparathyroidism 4
Chronic Kidney Disease 3
Renal Osteodystrophy 1
Hyperparathyroidism; Secondary, Renal 1
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Condition MeSH

Condition MeSH for Etelcalcetide
Intervention Trials
Hyperparathyroidism, Secondary 6
Hyperparathyroidism 6
Renal Insufficiency, Chronic 6
Kidney Diseases 5
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Clinical Trial Locations for Etelcalcetide

Trials by Country

Trials by Country for Etelcalcetide
Location Trials
United States 17
Spain 7
Canada 5
Belgium 2
Austria 2
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Trials by US State

Trials by US State for Etelcalcetide
Location Trials
New York 2
Pennsylvania 1
Ohio 1
North Carolina 1
New Jersey 1
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Clinical Trial Progress for Etelcalcetide

Clinical Trial Phase

Clinical Trial Phase for Etelcalcetide
Clinical Trial Phase Trials
Phase 3 4
Phase 2 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Etelcalcetide
Clinical Trial Phase Trials
Not yet recruiting 5
Recruiting 1
Completed 1
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Clinical Trial Sponsors for Etelcalcetide

Sponsor Name

Sponsor Name for Etelcalcetide
Sponsor Trials
Amgen 6
Thomas Nickolas, MD MS 1
Prim. Priv. Doz. Dr. Daniel Cejka 1
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Sponsor Type

Sponsor Type for Etelcalcetide
Sponsor Trials
Industry 6
Other 2
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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Moodys
Fish and Richardson
Cipla
Baxter
US Department of Justice

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