➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Medtronic
Moodys
Merck
Colorcon

Last Updated: August 9, 2020

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR ETELCALCETIDE

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

All Clinical Trials for Etelcalcetide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01896232 Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet Completed Amgen Phase 3 2013-08-01 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 2016-12-01 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.
NCT03283098 A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416 Completed Amgen Phase 1 2018-03-01 This was a multiple-dose, double-blind, randomized, placebo-controlled study. Chinese subjects residing in Mainland China with chronic kidney disease (CKD) receiving hemodialysis were randomized in a 3:1 ratio to receive 5 mg intravenous (IV) of etelcalcetide or placebo 3 times a week (TIW) for approximately 4 weeks, with a subsequent follow up period of approximately 4 weeks. Doses were given at the end of each scheduled hemodialysis session on study days 1 through day 27 and subject participation was complete after day 55 end-of-study (EOS) procedures were performed. Doses were administered TIW for 4 weeks, for a total of 12 doses.
NCT03299244 Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian HD Subjects With SHPT Not yet recruiting Amgen Phase 3 2018-01-31 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 2018-12-29 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 2019-02-01 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 >Start Date >Summary

Clinical Trial Conditions for Etelcalcetide

Condition Name

Condition Name for Etelcalcetide
Intervention Trials
Secondary Hyperparathyroidism 5
Chronic Kidney Disease 3
End Stage Renal Disease 1
Chronic Kidney Disease, Secondary Hyperparathyroidism 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Condition MeSH

Condition MeSH for Etelcalcetide
Intervention Trials
Hyperparathyroidism, Secondary 7
Hyperparathyroidism 7
Renal Insufficiency, Chronic 6
Neoplasm Metastasis 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Locations for Etelcalcetide

Trials by Country

Trials by Country for Etelcalcetide
Location Trials
United States 17
Spain 7
Canada 5
China 3
Austria 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Trials by US State

Trials by US State for Etelcalcetide
Location Trials
New York 2
New Jersey 1
Mississippi 1
Michigan 1
Louisiana 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Status

Clinical Trial Status for Etelcalcetide
Clinical Trial Phase Trials
Not yet recruiting 5
Completed 2
Recruiting 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Sponsors for Etelcalcetide

Sponsor Name

Sponsor Name for Etelcalcetide
Sponsor Trials
Amgen 7
Prim. Priv. Doz. Dr. Daniel Cejka 1
Thomas Nickolas, MD MS 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Sponsor Type

Sponsor Type for Etelcalcetide
Sponsor Trials
Industry 7
Other 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Dow
Express Scripts
McKesson
Baxter
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.