Clinical trial NCT01785875: Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
Official title: A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperparathyroidism, Secondary
Keywords: Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-02-07
Enrollment: 891
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
* Subject must complete the treatment and follow-up period, or have been discontinued for rising intact parathyroid hormone (iPTH), from an AMG 416 phase 3 parent study prior to the start of dosing in this study: 20120229 (NCT01785849), 20120230 (NCT01788046), or 20120359 (NCT01932970).
* Subject agrees to not participate in another study of an investigational agent during the study.
* Other Inclusion Criteria may apply

Exclusion Criteria:

* Currently receiving treatment in another investigational device or drug study.
* Currently receiving other investigational procedures while participating in this study.
* Subject has known sensitivity to any of the products or components to be administered during dosing.
* Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.

Other Exclusion Criteria may apply

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose until 30 days after last dose; the treatment period was 52 weeks.
measure: Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4
timeFrame: 52 weeks
measure: Number of Participants Who Developed Anti-etelcalcetide Antibodies
timeFrame: Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit
measure: Change From Baseline in Blood Pressure
timeFrame: Baseline and Weeks 24 and 48
Secondary outcomes:
measure: Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase
timeFrame: Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment)
measure: Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12
timeFrame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
measure: Percentage of Participants With PTH ≤ 300 pg/mL During the EAP
timeFrame: Baseline and the efficacy assessment phase
measure: Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12
timeFrame: Week 46 to 53
measure: Percent Change From Baseline in Mean PTH During the EAP
timeFrame: Baseline and the efficacy assessment phase
measure: Percent Change From Baseline in Mean PTH During the EAP12
timeFrame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
measure: Percent Change From Baseline in Mean Corrected Calcium During the EAP
timeFrame: Baseline and the efficacy assessment phase
measure: Percent Change From Baseline in Mean Corrected Calcium During the EAP12
timeFrame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
measure: Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP
timeFrame: Baseline and the efficacy assessment phase
measure: Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12
timeFrame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
measure: Percent Change From Baseline in Mean Phosphorus During the EAP
timeFrame: Baseline and the efficacy assessment phase
measure: Percent Change From Baseline in Mean Phosphorus During the EAP12
timeFrame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Pine Bluff
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state: Arkansas
city: Azusa
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state: California
city: Bakersfield
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state: California
city: Chula Vista
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country: Czechia
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city: Praha 4 - Nusle
country: Czechia
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country: France
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city: Marseille cedex 5
country: France
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city: Saint-Ouen
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city: Berlin
country: Germany
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country: Germany
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country: Germany
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city: Tel Aviv
country: Israel
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country: Israel
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country: Israel
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city: Ancona
country: Italy
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city: Lecco
country: Italy
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city: Milano
country: Italy
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city: Milano
country: Italy
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city: Pavia
country: Italy
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city: Verona
country: Italy
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city: Amsterdam
country: Netherlands
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city: Enschede
country: Netherlands
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city: Rotterdam
country: Netherlands
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city: Venlo
country: Netherlands
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Golub-Dobrzyn
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Rybnik
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Zamosc
country: Poland
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
state: Andalucía
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Majadahonda
country: Spain
facility: Research Site
state: Madrid
city: Madrid
country: Spain
facility: Research Site
city: Karlstad
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.
citation: Bushinsky DA, Chertow GM, Cheng S, Deng H, Kopyt N, Martin KJ, Rastogi A, Urena-Torres P, Vervloet M, Block GA. One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism. Nephrol Dial Transplant. 2020 Oct 1;35(10):1769-1778. doi: 10.1093/ndt/gfz039.