Hyperparathyroidism, SecondaryPhase 3NCT01785875

Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

A Phase 3 study testing Etelcalcetide in people with Hyperparathyroidism, Secondary, run by Amgen at 208 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Hyperparathyroidism, Secondary
What is being tested?: Etelcalcetide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 891 participants
Where: 208 sitesin 17 countries
Study dates: 31 Jul 2013to 1 Jul 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

208 sites in 17 countries.

Country

City, postcode or hospital

208 sites in 17 countries

United States101 sites

Research Site
Alexandria, Virginia, 22304
Research Site
Alexandria, Virginia, 22306
Research Site
Arlington, Texas, 76015
Research Site
Arvada, Colorado, 80002
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Augusta, Georgia, 30901
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Austin, Texas, 78758
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Azusa, California, 91702
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Bakersfield, California, 93308
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Baton Rouge, Louisiana, 70808
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Bethlehem, Pennsylvania, 18017
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Birmingham, Alabama, 35211
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Bluefield, West Virginia, 24701
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Brookhaven, Mississippi, 39601
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Brooklyn, New York, 11212
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Brooklyn, New York, 11235
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Carrboro, North Carolina, 27510
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Charlotte, North Carolina, 28207
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Chattanooga, Tennessee, 37408
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Chula Vista, California, 91910
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Cincinnati, Ohio, 45206
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Columbia, South Carolina, 29203
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Columbia, Tennessee, 38401
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Columbus, Mississippi, 39705
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Coral Springs, Florida, 33071
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Cudahy, California, 90201
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Denver, Colorado, 80230
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Detroit, Michigan, 48202
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Detroit, Michigan, 48236
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Durham, North Carolina, 27704
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Eatontown, New Jersey, 07724
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Edinburg, Texas, 78539
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Evanston, Illinois, 60201
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Fairfax, Virginia, 22033
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Fairfield, California, 94534
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Fort Worth, Texas, 76104
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Fort Worth, Texas, 76105
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Fort Worth, Texas, 76164
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Glendale, California, 91205
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Grand Prairie, Texas, 75050
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Great Neck, New York, 11021
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Gulfport, Mississippi, 39501
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Gurnee, Illinois, 60031
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Hampton, Virginia, 23666
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Houston, Texas, 77004
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Houston, Texas, 77054
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Kalamazoo, Michigan, 49007
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Kansas City, Missouri, 64111
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Knoxville, Tennessee, 37923
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Lafayette, Louisiana, 70503
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Las Vegas, Nevada, 89106
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Lauderdale Lakes, Florida, 33313
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Lincoln, Nebraska, 68510
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Los Angeles, California, 90022
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Los Angeles, California, 90025
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Los Angeles, California, 90048
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Lubbock, Texas, 79430
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Lynwood, California, 90262
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Macon, Georgia, 31217
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Mansfield, Texas, 76063
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Mechanicsville, Virginia, 23116
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Meridian, Idaho, 83642
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Merrillville, Indiana, 46410
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Miami, Florida, 33150
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Miami, Florida, 33173
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Michigan City, Indiana, 46360
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Nashville, Tennessee, 37205
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New Bern, North Carolina, 28562
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Norfolk, Virginia, 23502
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Northridge, California, 91324
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Norwalk, California, 90650
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Ocala, Florida, 34471
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Oklahoma City, Oklahoma, 73116
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Ontario, California, 91762
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Orangeburg, South Carolina, 29118
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Orchard Park, New York, 14127
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Pembroke Pines, Florida, 33025
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Philadelphia, Pennsylvania, 19106
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Philadelphia, Pennsylvania, 19118
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Pine Bluff, Arkansas, 71603
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Pinecrest, Florida, 33156
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Pontiac, Michigan, 48341
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Portsmouth, New Hampshire, 03801
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Reno, Nevada, 89511
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Ridgewood, New York, 11385
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Riverside, California, 92501
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Rosedale, New York, 11422
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San Antonio, Texas, 78205
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San Antonio, Texas, 78215
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San Antonio, Texas, 78229
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San Gabriel, California, 91776
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Shreveport, Louisiana, 71101
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Simi Valley, California, 93065
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Springfield, Massachusetts, 01107
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St Louis, Missouri, 63136
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Stamford, Connecticut, 06902
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Tampa, Florida, 33614
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The Bronx, New York, 10461
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Tupelo, Mississippi, 38801
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Whittier, California, 90603
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Wichita, Kansas, 67214-2998
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Yonkers, New York, 10704

Other trials in United States

Hungary11 sites

Research Site
Baja, 6500
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Budapest, 1037
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Budapest, 1076
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Budapest, 1106
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Esztergom, 2500
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Győr, 9023
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Kaposvár, 7400
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Kecskemét, 6000
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Miskolc, 3526
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Pécs, 7624
Research Site
Zalaegerszeg, 8900

Other trials in Hungary

Belgium10 sites

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Aalst, 9300
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Baudour, 7331
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Bonheiden, 2820
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Brussels, 1020
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Brussels, 1090
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Brussels, 1200
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Leuven, 3000
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Liège, 4000
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Roeselare, 8800
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Tournai, 7500

Other trials in Belgium

Poland10 sites

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Bialystok, 15-540
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Gdansk, 80-952
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Golub-Dobrzyń, 87-400
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Krakow, 31-501
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Lodz, 90-153
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Rybnik, 44-200
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Warsaw, 02-006
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Warsaw, 02-097
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Warsaw, 04-749
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Zamość, 87-100

Other trials in Poland

Czechia8 sites

Research Site
Hradec Králové, 500 05
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Nový Jičín, 741 01
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Pilsen, 301 00
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Prague, 140 21
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Prague, 169 00
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Praha 4 - Nusle, 140 00
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Slavkov u Brna, 684 01
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Ústí nad Orlicí, 562 18

Other trials in Czechia

France8 sites

Research Site
Bordeaux, 33076
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Caen, 14000
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La Tronche, 38701
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Marseille, 13253
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Marseille, 13385
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Poitiers, 86021
Research Site
Reims, 51092
Research Site
Saint-Ouen, 93400

Other trials in France

Russia8 sites

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Moscow, 123183
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Saint Petersburg, 191104
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Saint Petersburg, 195067
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Saint Petersburg, 195257
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Saint Petersburg, 196247
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Saint Petersburg, 197110
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Saint Petersburg, 198510
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Yaroslavl, 150062

Other trials in Russia

Spain8 sites

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Barcelona, Catalonia, 08003
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Barcelona, Catalonia, 08025
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Barcelona, Catalonia, 08035
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Barcelona, Catalonia, 08036
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Córdoba, Andalusia, 14004
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Madrid, 28041
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Majadahonda, Madrid, 28222
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Santander, Cantabria, 39008

Other trials in Spain

Australia7 sites

Research Site
Adelaide, South Australia, 5000
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Brisbane, Queensland, 4102
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Clayton, Victoria, 3168
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Liverpool, New South Wales, 2170
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Parkville, Victoria, 3050
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St Leonards, New South Wales, 2065
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Westmead, New South Wales, 2145

Other trials in Australia

Israel7 sites

Research Site
Ashkelon, 78278
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Jerusalem, 91120
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Kfar Saba, 44281
Research Site
Nahariya, 22100
Research Site
Tel Aviv, 64239
Research Site
Tel HaShomer, 52621
Research Site
Tsrifin, 70300

Other trials in Israel

Italy6 sites

Research Site
Ancona, 60131
Research Site
Lecco, 23900
Research Site
Milan, 20122
Research Site
Milan, 20142
Research Site
Pavia, 27100
Research Site
Verona, 37126

Other trials in Italy

Canada5 sites

Research Site
Brampton, Ontario, L6R 3J7
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Edmonton, Alberta, T6G 2B7
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Greenfield Park, Quebec, J4V 2H1
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Montreal, Quebec, H1T 2M4
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Montreal, Quebec, H4J 1C5

Other trials in Canada

United Kingdom5 sites

Research Site
Cambridge, CB2 2QQ
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Coventry, CV2 2DX
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London, NW3 2QG
Research Site
Nottingham, NG5 1PB
Research Site
Sheffield, S5 7AU

Other trials in United Kingdom

Germany4 sites

Research Site
Berlin, 12053
Research Site
Dresden, 01307
Research Site
Erfurt, 99089
Research Site
Villingen-Schwenningen, 78052

Other trials in Germany

Netherlands4 sites

Research Site
Amsterdam, 1081 HV
Research Site
Enschede, 7511 JX
Research Site
Rotterdam, 3079 DZ
Research Site
Venlo, 5912 BL

Other trials in Netherlands

Austria3 sites

Research Site
Graz, 8036
Research Site
Linz, 4010
Research Site
Vienna, 1090

Other trials in Austria

Sweden3 sites

Research Site
Karlstad, 651 85
Research Site
Stockholm, 141 86
Research Site
Uppsala, 751 85

Other trials in Sweden

About this study

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

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.

Conditions: Hyperparathyroidism, Secondary
Being tested: Etelcalcetide
Keywords: Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
Medical subject headings: Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic, Hypocalcemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EtelcalcetideDrug
Also called AMG 416
Administered by bolus injection into the venous line of the dialysis circuit at the end of hemodialysis treatment, and prior to or during rinse-back with each hemodialysis session (ie, 3 times per week).

Study groups in NCT01785875
Study group	Role	What they receive
Etelcalcetide	Experimental	Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL. Receives: Drug: Etelcalcetide

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs)
Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.
Measured: From first dose until 30 days after last dose; the treatment period was 52 weeks.
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4
Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated.
Measured: 52 weeks
Number of Participants Who Developed Anti-etelcalcetide Antibodies
A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported.
Measured: Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit
Change From Baseline in Blood Pressure
Blood pressure (BP) values were taken post-hemodialysis assessments.
Measured: Baseline and Weeks 24 and 48

Secondary outcomes (12)

Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase
The efficacy assessment phase (EAP) is defined as the last 6 weeks before ending treatment, which was only for participants who completed a minimum of 8 weeks of treatment with etelcalcetide. If multiple assessments were available during the EAP, values were averaged.
Measured: 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)
Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12
The efficacy assessment phase at 12 months (EAP12) was defined as the period from week 46 to 53 (inclusive). If multiple assessments were available during the EAP12, values were averaged.
Measured: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percentage of Participants With PTH ≤ 300 pg/mL During the EAP
Measured: Baseline and the efficacy assessment phase
Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12
Measured: Week 46 to 53
Percent Change From Baseline in Mean PTH During the EAP
Measured: Baseline and the efficacy assessment phase
Percent Change From Baseline in Mean PTH During the EAP12
Measured: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percent Change From Baseline in Mean Corrected Calcium During the EAP
Measured: Baseline and the efficacy assessment phase
Percent Change From Baseline in Mean Corrected Calcium During the EAP12
Measured: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP
Measured: Baseline and the efficacy assessment phase
Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12
Measured: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percent Change From Baseline in Mean Phosphorus During the EAP
Measured: Baseline and the efficacy assessment phase
Percent Change From Baseline in Mean Phosphorus During the EAP12
Measured: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 20131 Jul 2015

First posted7 Feb 2013 (estimated)
Study start31 Jul 2013
Primary completion1 Jul 2015
Study completion1 Jul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hyperparathyroidism, SecondaryStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 891 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01785875
Sponsor's protocol ID: 20120231
Other IDs: KAI-4169-008, 2012-002808-41
Status last verified: Apr 2019
First submitted: 5 Feb 2013
Last updated: 10 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 30875390
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.
PubMed 30859218

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder

All Hyperparathyroidism, Secondary trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01785875
Acronym / sponsor ID: 20120231
Conditions: Hyperparathyroidism, Secondary
Keywords: Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 891 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 31 Jul 2013 (actual)
Primary completion: 1 Jul 2015 (actual)
Study completion: 1 Jul 2015 (actual)
First posted: 7 Feb 2013 (estimated)
Results: Posted 27 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Etelcalcetide	Experimental	Drug: EtelcalcetideParticipants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EtelcalcetideAlso: AMG 416Administered by bolus injection into the venous line of the dialysis circuit at the end of hemodialysis treatment, and prior to or during rinse-back with each hemodialysis session (ie, 3 times per week).	Drug	Etelcalcetide

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: From first dose until 30 days after last dose; the treatment period was 52 weeks.
Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4
Time frame: 52 weeks
Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated.
Number of Participants Who Developed Anti-etelcalcetide Antibodies
Time frame: Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit
A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported.
Change From Baseline in Blood Pressure
Time frame: Baseline and Weeks 24 and 48
Blood pressure (BP) values were taken post-hemodialysis assessments.

12 secondary outcomes

Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase
Time frame: 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)
Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12
Time frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percentage of Participants With PTH ≤ 300 pg/mL During the EAP
Time frame: Baseline and the efficacy assessment phase
Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12
Time frame: Week 46 to 53
Percent Change From Baseline in Mean PTH During the EAP
Time frame: Baseline and the efficacy assessment phase
Percent Change From Baseline in Mean PTH During the EAP12
Time frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percent Change From Baseline in Mean Corrected Calcium During the EAP
Time frame: Baseline and the efficacy assessment phase
Percent Change From Baseline in Mean Corrected Calcium During the EAP12
Time frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP
Time frame: Baseline and the efficacy assessment phase
Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12
Time frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Percent Change From Baseline in Mean Phosphorus During the EAP
Time frame: Baseline and the efficacy assessment phase
Percent Change From Baseline in Mean Phosphorus During the EAP12
Time frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)

Results and safety

Results posted to the registry on 27 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
20120229 / 20120230 Placebo	384	90
20120229 / 20120230 Etelcalcetide	384	95
20120359 Etelcalcetide	123	16

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: From first dose until 30 days after last dose; the treatment period was 52 weeks.. Number. Unit: participants

Measure	20120229 / 20120230 Placebo n = 383	20120229 / 20120230 Etelcalcetide n = 384	20120359 Etelcalcetide n = 123	Etelcalcetide Total n = 890
Any adverse event	354	337	108	799
Serious adverse events	161	142	53	356
Treatment-related adverse events	215	141	36	392
Treatment-related serious adverse events	6	5	2	13
AEs leading to discontinuation of etelcalcetide	22	11	8	41
Fatal adverse events	27	16	8	51

Population analysed: All participants who received at least 1 dose of etelcalcetide.

Primary outcome: Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4

Time frame: 52 weeks. Number. Unit: participants

Measure	Etelcalcetide Total n = 890
Alanine aminotransferase increase	1
Albumin decrease	9
Alkaline phosphatase increase	2
Aspartate aminotransferase increase	3
Bilirubin increase	1
Calcium (corrected) decrease	51
Calcium (corrected) increase	8
Phosphorus decrease	77

Population analysed: All participants who received at least 1 dose of etelcalcetide.

Primary outcome: Number of Participants Who Developed Anti-etelcalcetide Antibodies

Time frame: Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit. Number. Unit: participants

Measure	20120229 / 20120230 Placebo n = 369	20120229 / 20120230 Etelcalcetide n = 384	20120359 Etelcalcetide n = 123	Etelcalcetide Total n = 876
Value	10	15	2	27

Population analysed: Participants who received at least 1 dose of etelcalcetide and with a post-baseline antibody result.

Primary outcome: Change From Baseline in Blood Pressure

Time frame: Baseline and Weeks 24 and 48. Mean (Standard Error). Unit: mmHg

Measure	20120229 / 20120230 Placebo n = 383	20120229 / 20120230 Etelcalcetide n = 384	20120359 Etelcalcetide n = 123	Etelcalcetide Total n = 890
Systolic BP Week 24 (n = 329, 342, 104, 775)	4.0 (1.5)	4.5 (1.4)	-5.5 (2.8)	2.9 (1.0)
Systolic BP Week 48 (n = 305, 317, 74, 696)	3.5 (1.6)	6.5 (1.5)	-6.8 (3.0)	3.8 (1.0)
Diastolic BP Week 24 (n = 329, 343, 104, 776)	2.2 (0.8)	1.2 (0.9)	-5.1 (1.5)	0.8 (0.6)
Diastolic BP Week 48 (n = 305, 317, 74, 696)	1.1 (0.9)	0.8 (0.9)	-2.6 (1.7)	0.6 (0.6)

Population analysed: Participants who received at least 1 dose of etelcalcetide and with available data at each time point (indicated by n)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose until 30 days after last dose; the treatment period was 52 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
20120229 / 20120230 Placebo	161 of 383 (42%)	289 of 383 (75.5%)	Not reported
20120229 / 20120230 Etelcalcetide	142 of 384 (37%)	249 of 384 (64.8%)	Not reported
20120359 Etelcalcetide	53 of 123 (43.1%)	75 of 123 (61%)	Not reported
Total	356 of 890 (40%)	613 of 890 (68.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30875390Block 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.
Derived from this study: PubMed 30859218Bushinsky 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.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

208 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etelcalcetide in people with Hyperparathyroidism, Secondary, run by Amgen at 208 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 208 sites in United States, Hungary, Belgium, Poland, Czechia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) (time frame: From first dose until 30 days after last dose; the treatment period was 52 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01785875, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.