Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
NCT ID: NCT01785875
Last Updated: 2019-04-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
891 participants
INTERVENTIONAL
2013-07-31
2015-07-01
Brief Summary
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Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
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Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
NCT01788046
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
NCT01785849
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
NCT02833857
Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism
NCT01576146
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Etelcalcetide
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.
Etelcalcetide
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).
Interventions
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Etelcalcetide
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
100 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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Birmingham, Alabama, United States
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Pine Bluff, Arkansas, United States
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Azusa, California, United States
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Bakersfield, California, United States
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Chula Vista, California, United States
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Cudahy, California, United States
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Fairfield, California, United States
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Glendale, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Lynwood, California, United States
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Northridge, California, United States
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Norwalk, California, United States
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Ontario, California, United States
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Riverside, California, United States
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San Gabriel, California, United States
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Simi Valley, California, United States
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Whittier, California, United States
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Arvada, Colorado, United States
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Denver, Colorado, United States
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Stamford, Connecticut, United States
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Coral Springs, Florida, United States
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Lauderdale Lakes, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, 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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Augusta, Georgia, United States
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Macon, Georgia, United States
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Meridian, Idaho, United States
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Evanston, Illinois, United States
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Gurnee, Illinois, United States
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Merrillville, Indiana, United States
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Michigan City, Indiana, United States
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Wichita, Kansas, United States
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Baton Rouge, Louisiana, United States
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Lafayette, Louisiana, United States
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Shreveport, Louisiana, United States
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Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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Detroit, Michigan, United States
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Kalamazoo, Michigan, United States
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Pontiac, Michigan, United States
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Brookhaven, Mississippi, United States
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Columbus, Mississippi, United States
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Gulfport, Mississippi, United States
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Tupelo, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Portsmouth, New Hampshire, United States
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Eatontown, New Jersey, United States
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Brooklyn, New York, United States
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Brooklyn, New York, United States
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Great Neck, New York, United States
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Orchard Park, 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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Yonkers, New York, United States
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Carrboro, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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New Bern, North Carolina, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Bethlehem, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Columbia, South Carolina, United States
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Orangeburg, South Carolina, United States
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Chattanooga, Tennessee, United States
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Columbia, Tennessee, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Edinburg, Texas, United States
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Fort Worth, Texas, United States
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Fort Worth, Texas, United States
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Fort Worth, Texas, United States
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Grand Prairie, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Mansfield, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Alexandria, Virginia, United States
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Alexandria, Virginia, United States
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Fairfax, Virginia, United States
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Hampton, Virginia, United States
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Mechanicsville, Virginia, United States
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Norfolk, Virginia, United States
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Bluefield, West Virginia, United States
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Liverpool, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Westmead, New South Wales, Australia
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Brisbane, Queensland, Australia
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Adelaide, South Australia, Australia
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Clayton, Victoria, Australia
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Parkville, Victoria, Australia
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Graz, , Austria
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Linz, , Austria
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Vienna, , Austria
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Aalst, , Belgium
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Baudour, , Belgium
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Bonheiden, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Roeselare, , Belgium
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Tournai, , Belgium
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Edmonton, Alberta, Canada
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Brampton, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Hradec Králové, , Czechia
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Nový Jičín, , Czechia
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Pilsen, , Czechia
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Prague, , 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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Ústí nad Orlicí, , Czechia
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Bordeaux, , France
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Caen, , France
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La Tronche, , France
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Marseille, , France
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Marseille, , France
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Poitiers, , France
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Reims, , France
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Saint-Ouen, , France
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Berlin, , Germany
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Dresden, , Germany
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Erfurt, , Germany
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Villingen-Schwenningen, , Germany
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Baja, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Esztergom, , Hungary
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Győr, , Hungary
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Kaposvár, , Hungary
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Kecskemét, , Hungary
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Miskolc, , Hungary
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Pécs, , Hungary
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Zalaegerszeg, , Hungary
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Ashkelon, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Nahariya, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Ẕerifin, , Israel
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Ancona, , Italy
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Lecco, , Italy
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Milan, , Italy
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Milan, , Italy
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Pavia, , Italy
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Verona, , Italy
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Amsterdam, , Netherlands
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Enschede, , Netherlands
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Rotterdam, , Netherlands
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Venlo, , Netherlands
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Bialystok, , Poland
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Gdansk, , Poland
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Golub-Dobrzyń, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Rybnik, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Zamość, , Poland
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Moscow, , 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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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Córdoba, Andalusia, Spain
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Santander, Cantabria, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Majadahonda, Madrid, Spain
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Madrid, , Spain
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Karlstad, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Cambridge, , United Kingdom
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Coventry, , United Kingdom
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London, , United Kingdom
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Nottingham, , United Kingdom
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Sheffield, , United Kingdom
Countries
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References
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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.
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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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KAI-4169-008
Identifier Type: OTHER
Identifier Source: secondary_id
2012-002808-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20120231
Identifier Type: -
Identifier Source: org_study_id
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