Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
NCT ID: NCT01896232
Last Updated: 2019-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
683 participants
INTERVENTIONAL
2013-08-13
2015-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cinacalcet
Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
Cinacalcet
Cinacalcet was administered orally once a day. The starting dose was 30 mg daily, titrated up to 180 mg daily based on serum PTH and corrected calcium levels.
Intravenous Placebo
Administered intravenously (IV) three times per week.
Etelcalcetide
Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Etelcalcetide
Administered intravenously three times per week. The starting dose was 5 mg, titrated up to 15 mg based on serum PTH and corrected calcium levels.
Oral Placebo
Administered orally once a day.
Interventions
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Etelcalcetide
Administered intravenously three times per week. The starting dose was 5 mg, titrated up to 15 mg based on serum PTH and corrected calcium levels.
Cinacalcet
Cinacalcet was administered orally once a day. The starting dose was 30 mg daily, titrated up to 180 mg daily based on serum PTH and corrected calcium levels.
Oral Placebo
Administered orally once a day.
Intravenous Placebo
Administered intravenously (IV) three times per week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have SHPT as defined by one central laboratory screening predialysis serum PTH value \> 500 pg/mL, measured on separate days within 2 weeks prior to randomization
* Subjects must have one serum cCa value ≥ 8.3 mg/dL obtained before dialysis within 2 weeks of the date of randomization
* Subjects receiving calcium supplements must have no more than a maximum dose change of 50% within 2 weeks before screening laboratory assessments are obtained, and the dose must remain unchanged through randomization
Exclusion Criteria
* Other criteria may apply
18 Years
85 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Azusa, California, United States
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Bakersfield, California, United States
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Bakersfield, California, United States
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Chula Vista, California, United States
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Covina, California, United States
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Granada Hills, California, United States
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La Mesa, California, United States
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La Puente, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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San Gabriel, California, United States
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Whittier, California, United States
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Arvada, Colorado, United States
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Aurora, Colorado, United States
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Longmont, Colorado, United States
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Westminster, Colorado, United States
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Orange, Connecticut, United States
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Pembroke Pines, Florida, United States
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Pinecrest, Florida, United States
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Tampa, Florida, United States
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Baton Rouge, Louisiana, United States
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Lafayette, Louisiana, United States
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Southgate, Michigan, United States
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Columbus, Mississippi, United States
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Gulfport, Mississippi, United States
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Sewell, New Jersey, United States
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Great Neck, New York, United States
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Mineola, New York, United States
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Ridgewood, New York, United States
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Rosedale, New York, United States
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The Bronx, New York, United States
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Wilmington, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Burlington, Vermont, United States
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Fairfax, Virginia, United States
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Portsmouth, Virginia, United States
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Madison, Wisconsin, United States
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Feldkirch, , Austria
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Linz, , Austria
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Vienna, , Austria
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Genk, , Belgium
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Hasselt, , Belgium
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Kortrijk, , Belgium
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Roeselare, , Belgium
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Edmonton, Alberta, Canada
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Saint John, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Brampton, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Nový Jičín, , Czechia
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Prague, , Czechia
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Praha 4 - Nusle, , Czechia
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Slavkov u Brna, , Czechia
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Třinec, , Czechia
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Ústí nad Orlicí, , Czechia
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Aalborg, , Denmark
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Copenhagen, , Denmark
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Fredericia, , Denmark
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Odense, , Denmark
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Roskilde, , Denmark
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Boulogne-sur-Mer, , France
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Lille, , France
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Nouilly, , France
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Paris, , France
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Paris, , France
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Saint-Ouen, , France
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Saint-Priest-en-Jarez, , France
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Sainte-Foy-lès-Lyon, , France
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Aachen, , Germany
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Coburg, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Magdeburg, , Germany
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Mettmann, , Germany
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Minden, , Germany
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München, , Germany
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Wiesbaden, , Germany
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Zwickau, , Germany
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Alexandroupoli, , Greece
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Athens, , Greece
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Ioannina, , Greece
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Larissa, , Greece
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Nikaia, Piraeus, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Győr, , Hungary
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Kaposvár, , Hungary
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Kistarcsa, , Hungary
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Pécs, , Hungary
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Pécs, , Hungary
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Székesfehérvár, , Hungary
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Szigetvár, , Hungary
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Zalaegerszeg, , Hungary
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Cagliari, , Italy
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Florence, , Italy
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Genova, , Italy
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Lecco, , Italy
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Lucca, , Italy
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Milan, , Italy
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Pavia, , Italy
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Pisa, , Italy
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Pordenone, , Italy
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San Giovanni Rotondo FG, , Italy
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Riga, , Latvia
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Riga, , Latvia
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Valmiera, , Latvia
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Alytus, , Lithuania
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Kaunas, , Lithuania
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Kaunas, , Lithuania
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Kėdainiai, , Lithuania
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Klaipėda, , Lithuania
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Šiauliai, , Lithuania
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Ukmerge, , Lithuania
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Hamilton, , New Zealand
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Papatoetoe, Auckland, , New Zealand
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Takapuna, Auckland City, , New Zealand
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Gdansk, , Poland
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Katowice, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Sieradz, , Poland
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Wadowice, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Zabrze, , Poland
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Żyrardów, , Poland
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Almada, , Portugal
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Aveiro, , Portugal
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Estoril, , Portugal
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Forte Da Casa, , Portugal
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Guimarães, , Portugal
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Lisbon, , Portugal
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Santo Tirso, , Portugal
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Setúbal, , Portugal
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Vila Franca de Xira, , Portugal
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Mitishi, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Petrozavodsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Córdoba, Andalusia, Spain
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Puerto Real, Andalusia, Spain
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Galdakao, Basque Country, Spain
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Badalona, Catalonia, Spain
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Lleida, Catalonia, Spain
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Badajoz, Extremadura, Spain
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Pamplona, Navarre, Spain
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Torrevieja, Valencia, Spain
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Valencia, Valencia, Spain
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Madrid, , Spain
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Madrid, , Spain
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Malmo, , Sweden
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Stockholm, , Sweden
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Trollhättan, , Sweden
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Aarau, , Switzerland
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Bern, , Switzerland
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Geneva, , Switzerland
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Lausanne, , Switzerland
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Lausanne, , Switzerland
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Locarno, , Switzerland
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Zurich, , Switzerland
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
Countries
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References
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Block GA, Bushinsky DA, Cheng S, Cunningham J, Dehmel B, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Moe SM, Patel UD, Silver J, Sun Y, Wang H, Chertow GM. Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial. JAMA. 2017 Jan 10;317(2):156-164. doi: 10.1001/jama.2016.19468.
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.
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.
Wu B, Melhem M, Subramanian R, Chen P, Jaramilla Sloey B, Fouqueray B, Hock MB, Skiles GL, Chow AT, Lee E. Clinical Pharmacokinetics and Pharmacodynamics of Etelcalcetide, a Novel Calcimimetic for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis. J Clin Pharmacol. 2018 Jun;58(6):717-726. doi: 10.1002/jcph.1090. Epub 2018 Mar 13.
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.
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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2013-000192-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20120360
Identifier Type: -
Identifier Source: org_study_id
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