Clinical trial NCT01788046: Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the 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: 2013-02-11
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
* Subject is 18 years of age or older.
* Subject agrees to not participate in another study of an investigational agent during the study.
* Subject must be receiving hemodialysis 3 times weekly for at least 3 months
* Other Inclusion Criteria may apply

Exclusion Criteria:

* Currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening.
* Other investigational procedures while participating in this study are excluded.
* Anticipated or scheduled parathyroidectomy during the study period.
* Subject has received a parathyroidectomy within 3 months prior to dosing.
* Anticipated or scheduled kidney transplant during the study period.
* Subject has known sensitivity to any of the products or components to be administered during dosing.
* Subject has participated in a prior clinical trial of AMG 416
* 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.
* Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.
* Other Exclusion Criteria may apply

Primary outcomes:
measure: Percentage of Participants With > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase
timeFrame: Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).
Secondary outcomes:
measure: Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase
timeFrame: Baseline and the efficacy assessment phase (Week 20 to Week 27)
measure: Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase
timeFrame: Baseline and the Efficacy Assessment Phase (Week 20 to Week 27)
measure: Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase
timeFrame: Baseline and the efficacy assessment phase (Week 20 to Week 27)
measure: Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase
timeFrame: Baseline and the efficacy assessment phase (Week 20 to Week 27)
measure: Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase
timeFrame: Baseline and the efficacy assessment phase (Week 20 to Week 27)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Azusa
country: United States
facility: Research Site
state: California
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Chula Vista
country: United States
facility: Research Site
state: California
city: Fairfield
country: United States
facility: Research Site
state: California
city: Glendale
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Northridge
country: United States
facility: Research Site
state: California
city: Norwalk
country: United States
facility: Research Site
state: California
city: Riverside
country: United States
facility: Research Site
state: California
city: Simi Valley
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Stamford
country: United States
facility: Research Site
state: Connecticut
city: Lauderdale Lakes
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Ocala
country: United States
facility: Research Site
state: Florida
city: Augusta
country: United States
facility: Research Site
state: Georgia
city: Macon
country: United States
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state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Gurnee
country: United States
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state: Illinois
city: Merrillville
country: United States
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state: Indiana
city: Wichita
country: United States
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state: Kansas
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Bethesda
country: United States
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state: Maryland
city: Fort Washington
country: United States
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state: Maryland
city: Detroit
country: United States
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state: Michigan
city: Brookhaven
country: United States
facility: Research Site
state: Mississippi
city: Lincoln
country: United States
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state: Nebraska
city: Las Vegas
country: United States
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state: Nevada
city: Eatontown
country: United States
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state: New Jersey
city: Brooklyn
country: United States
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state: New York
city: Fresh Meadows
country: United States
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state: New York
city: Great Neck
country: United States
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state: New York
city: Charlotte
country: United States
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state: North Carolina
city: New Bern
country: United States
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state: North Carolina
city: Cincinnati
country: United States
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state: Ohio
city: Columbia
country: United States
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state: South Carolina
city: Chattanooga
country: United States
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state: Tennessee
city: Knoxville
country: United States
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state: Tennessee
city: Arlington
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Lubbock
country: United States
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state: Texas
city: Rutland
country: United States
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state: Vermont
city: Alexandria
country: United States
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state: Virginia
city: Morgantown
country: United States
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state: West Virginia
city: Westmead
country: Australia
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state: New South Wales
city: Brisbane
country: Australia
facility: Research Site
state: Queensland
city: Adelaide
country: Australia
facility: Research Site
state: South Australia
city: Clayton
country: Australia
facility: Research Site
state: Victoria
city: Bonheiden
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Brussel
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
facility: Research Site
city: Tournai
country: Belgium
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: New Westminister
country: Canada
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state: British Columbia
city: Halifax
country: Canada
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state: Nova Scotia
city: Toronto
country: Canada
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state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Novy Jicin
country: Czechia
facility: Research Site
city: Plzen
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Usti nad Orlici
country: Czechia
facility: Research Site
city: Bordeaux Cedex
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Grenoble
country: France
facility: Research Site
city: Marseille cedex 5
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Perpignan Cedex
country: France
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Esztergom
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Kfar-Saba
country: Israel
facility: Research Site
city: Tel Hashomer
country: Israel
facility: Research Site
city: Zerifin
country: Israel
facility: Research Site
city: Ancona
country: Italy
facility: Research Site
city: Lecco
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Quartu Sant'Elena CA
country: Italy
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Enschede
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Venlo
country: Netherlands
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: Moscow
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: Granada
country: Spain
facility: Research Site
state: Andalucía
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: Karlstad
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Block GA, Bushinsky DA, Cunningham J, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Mix TC, Moe SM, Patel UD, Silver J, Spiegel DM, Sterling L, Walsh L, Chertow GM. Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials. JAMA. 2017 Jan 10;317(2):146-155. doi: 10.1001/jama.2016.19456.
citation: Kroenke MA, Weeraratne DK, Deng H, Sloey B, Subramanian R, Wu B, Serenko M, Hock MB. Clinical immunogenicity of the d-amino acid peptide therapeutic etelcalcetide: Method development challenges and anti-drug antibody clinical impact assessments. J Immunol Methods. 2017 Jun;445:37-44. doi: 10.1016/j.jim.2017.03.005. Epub 2017 Mar 6.
citation: Stollenwerk B, Iannazzo S, Akehurst R, Adena M, Briggs A, Dehmel B, Parfrey P, Belozeroff V. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet. Pharmacoeconomics. 2018 May;36(5):603-612. doi: 10.1007/s40273-017-0605-2.
citation: Stollenwerk B, Iannazzo S, Cooper K, Belozeroff V. Exploring the potential value of improved care for secondary hyperparathyroidism with a novel calcimimetic therapy. J Med Econ. 2017 Oct;20(10):1110-1115. doi: 10.1080/13696998.2017.1360309. Epub 2017 Aug 14.
citation: Chen P, Narayanan A, Wu B, Gisleskog PO, Gibbs JP, Chow AT, Melhem M. Population Pharmacokinetic and Pharmacodynamic Modeling of Etelcalcetide in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Hemodialysis. Clin Pharmacokinet. 2018 Jan;57(1):71-85. doi: 10.1007/s40262-017-0550-4.
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: Cunningham J, Block GA, Chertow GM, Cooper K, Evenepoel P, Iles J, Sun Y, Urena-Torres P, Bushinsky DA. Etelcalcetide Is Effective at All Levels of Severity of Secondary Hyperparathyroidism in Hemodialysis Patients. Kidney Int Rep. 2019 Apr 16;4(7):987-994. doi: 10.1016/j.ekir.2019.04.010. eCollection 2019 Jul.
citation: Wolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, Sun Y, Tomlin H, Vervloet M, Oberbauer R. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2019 Apr 26;13(1):75-84. doi: 10.1093/ckj/sfz034. eCollection 2020 Feb.
citation: Hain D, Tomlin H, Gibson C. Administration of Etelcalcetide for the Treatment of Secondary Hyperparathyroidism in Patients with CKD-MBD on Hemodialysis: A Nephrology Nursing Perspective. Nephrol Nurs J. 2019 May-Jun;46(3):315-290.