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Brief Title: 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 ID: NCT01788046
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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Mobile, Alabama, United States
Research Site, Azusa, California, United States
Research Site, Beverly Hills, California, United States
Research Site, Chula Vista, California, United States
Research Site, Fairfield, California, United States
Research Site, Glendale, California, United States
Research Site, Los Angeles, California, United States
Research Site, Northridge, California, United States
Research Site, Norwalk, California, United States
Research Site, Riverside, California, United States
Research Site, Simi Valley, California, United States
Research Site, Denver, Colorado, United States
Research Site, Stamford, Connecticut, United States
Research Site, Lauderdale Lakes, Florida, United States
Research Site, Miami, Florida, United States
Research Site, Ocala, Florida, United States
Research Site, Augusta, Georgia, United States
Research Site, Macon, Georgia, United States
Research Site, Chicago, Illinois, United States
Research Site, Gurnee, Illinois, United States
Research Site, Merrillville, Indiana, United States
Research Site, Wichita, Kansas, United States
Research Site, Shreveport, Louisiana, United States
Research Site, Bethesda, Maryland, United States
Research Site, Fort Washington, Maryland, United States
Research Site, Detroit, Michigan, United States
Research Site, Brookhaven, Mississippi, United States
Research Site, Lincoln, Nebraska, United States
Research Site, Las Vegas, Nevada, United States
Research Site, Eatontown, New Jersey, United States
Research Site, Brooklyn, New York, United States
Research Site, Fresh Meadows, New York, United States
Research Site, Great Neck, New York, United States
Research Site, Charlotte, North Carolina, United States
Research Site, New Bern, North Carolina, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Columbia, South Carolina, United States
Research Site, Chattanooga, Tennessee, United States
Research Site, Knoxville, Tennessee, United States
Research Site, Arlington, Texas, United States
Research Site, Houston, Texas, United States
Research Site, Lubbock, Texas, United States
Research Site, Rutland, Vermont, United States
Research Site, Alexandria, Virginia, United States
Research Site, Morgantown, West Virginia, United States
Research Site, Westmead, New South Wales, Australia
Research Site, Brisbane, Queensland, Australia
Research Site, Adelaide, South Australia, Australia
Research Site, Clayton, Victoria, Australia
Research Site, Bonheiden, , Belgium
Research Site, Brussels, , Belgium
Research Site, Brussel, , Belgium
Research Site, Liege, , Belgium
Research Site, Roeselare, , Belgium
Research Site, Tournai, , Belgium
Research Site, Edmonton, Alberta, Canada
Research Site, New Westminister, British Columbia, Canada
Research Site, Halifax, Nova Scotia, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Novy Jicin, , Czechia
Research Site, Plzen, , Czechia
Research Site, Praha 4, , Czechia
Research Site, Usti nad Orlici, , Czechia
Research Site, Bordeaux Cedex, , France
Research Site, Caen, , France
Research Site, Grenoble, , France
Research Site, Marseille cedex 5, , France
Research Site, Marseille, , France
Research Site, Perpignan Cedex, , France
Research Site, Erfurt, , Germany
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Esztergom, , Hungary
Research Site, Kecskemet, , Hungary
Research Site, Miskolc, , Hungary
Research Site, Zalaegerszeg, , Hungary
Research Site, Jerusalem, , Israel
Research Site, Kfar-Saba, , Israel
Research Site, Tel Hashomer, , Israel
Research Site, Zerifin, , Israel
Research Site, Ancona, , Italy
Research Site, Lecco, , Italy
Research Site, Milano, , Italy
Research Site, Quartu Sant'Elena CA, , Italy
Research Site, Amsterdam, , Netherlands
Research Site, Enschede, , Netherlands
Research Site, Rotterdam, , Netherlands
Research Site, Venlo, , Netherlands
Research Site, Gdansk, , Poland
Research Site, Golub-Dobrzyn, , Poland
Research Site, Krakow, , Poland
Research Site, Lodz, , Poland
Research Site, Rybnik, , Poland
Research Site, Warszawa, , Poland
Research Site, Moscow, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Yaroslavl, , Russian Federation
Research Site, Cordoba, Andalucía, Spain
Research Site, Granada, Andalucía, Spain
Research Site, Barcelona, Cataluña, Spain
Research Site, Barcelona, Cataluña, Spain
Research Site, Majadahonda, Madrid, Spain
Research Site, Karlstad, , Sweden
Research Site, Stockholm, , Sweden
Research Site, Uppsala, , Sweden
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR