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Clinical Trial Details

Trial ID: L1704
Source ID: NCT01788046
Associated Drug: Etelcalcetide
Title: Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01788046/results
Conditions: Hyperparathyroidism, Secondary
Interventions: DRUG: Etelcalcetide|DRUG: Placebo
Outcome Measures: Primary: Percentage of Participants With > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase, Participants who did not have any scheduled assessments during the EAP were considered non-responders., Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive). | Secondary: Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase, Participants who had no scheduled assessments during the EAP were considered non-responders., Baseline and the efficacy assessment phase (Week 20 to Week 27)|Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase, Baseline and the Efficacy Assessment Phase (Week 20 to Week 27)|Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase, Baseline and the efficacy assessment phase (Week 20 to Week 27)|Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase, Baseline and the efficacy assessment phase (Week 20 to Week 27)|Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase, Baseline and the efficacy assessment phase (Week 20 to Week 27)
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 515
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-03-12
Completion Date: 2014-05-09
Results First Posted: 2017-03-27
Last Update Posted: 2019-08-20
Locations: Research Site, Mobile, Alabama, 36608, United States|Research Site, Azusa, California, 91702, United States|Research Site, Beverly Hills, California, 90211, United States|Research Site, Chula Vista, California, 91910, United States|Research Site, Fairfield, California, 94534, United States|Research Site, Glendale, California, 91205, United States|Research Site, Los Angeles, California, 90022, United States|Research Site, Northridge, California, 91324, United States|Research Site, Norwalk, California, 90650, United States|Research Site, Riverside, California, 92501, United States|Research Site, Simi Valley, California, 93065, United States|Research Site, Denver, Colorado, 80230, United States|Research Site, Stamford, Connecticut, 06902, United States|Research Site, Lauderdale Lakes, Florida, 33313, United States|Research Site, Miami, Florida, 33173, United States|Research Site, Ocala, Florida, 34471, United States|Research Site, Augusta, Georgia, 30901, United States|Research Site, Macon, Georgia, 31217, United States|Research Site, Chicago, Illinois, 60616, United States|Research Site, Gurnee, Illinois, 60031, United States|Research Site, Merrillville, Indiana, 46410, United States|Research Site, Wichita, Kansas, 67214-2998, United States|Research Site, Shreveport, Louisiana, 71101, United States|Research Site, Bethesda, Maryland, 20817, United States|Research Site, Fort Washington, Maryland, 20744, United States|Research Site, Detroit, Michigan, 48202, United States|Research Site, Brookhaven, Mississippi, 39601, United States|Research Site, Lincoln, Nebraska, 68510, United States|Research Site, Las Vegas, Nevada, 89106, United States|Research Site, Eatontown, New Jersey, 07724, United States|Research Site, Brooklyn, New York, 11212, United States|Research Site, Fresh Meadows, New York, 11365, United States|Research Site, Great Neck, New York, 11021, United States|Research Site, Charlotte, North Carolina, 28207, United States|Research Site, New Bern, North Carolina, 28562, United States|Research Site, Cincinnati, Ohio, 45206, United States|Research Site, Columbia, South Carolina, 29203, United States|Research Site, Chattanooga, Tennessee, 37408, United States|Research Site, Knoxville, Tennessee, 37923, United States|Research Site, Arlington, Texas, 76015, United States|Research Site, Houston, Texas, 77054, United States|Research Site, Lubbock, Texas, 79430, United States|Research Site, Rutland, Vermont, 05701, United States|Research Site, Alexandria, Virginia, 22304, United States|Research Site, Morgantown, West Virginia, 26506-9165, United States|Research Site, Westmead, New South Wales, 2145, Australia|Research Site, Brisbane, Queensland, 4102, Australia|Research Site, Adelaide, South Australia, 5000, Australia|Research Site, Clayton, Victoria, 3168, Australia|Research Site, Bonheiden, 2820, Belgium|Research Site, Brussels, 1200, Belgium|Research Site, Brussel, 1090, Belgium|Research Site, Liege, 4000, Belgium|Research Site, Roeselare, 8800, Belgium|Research Site, Tournai, 7500, Belgium|Research Site, Edmonton, Alberta, T6G 2B7, Canada|Research Site, New Westminister, British Columbia, V3L 0A6, Canada|Research Site, Halifax, Nova Scotia, B3H 1V7, Canada|Research Site, Toronto, Ontario, M5C 2T2, Canada|Research Site, Montreal, Quebec, H4J 1C5, Canada|Research Site, Novy Jicin, 741 01, Czechia|Research Site, Plzen, 301 00, Czechia|Research Site, Praha 4, 140 21, Czechia|Research Site, Usti nad Orlici, 562 18, Czechia|Research Site, Bordeaux Cedex, 33075, France|Research Site, Caen, 14000, France|Research Site, Grenoble, 38000, France|Research Site, Marseille cedex 5, 13385, France|Research Site, Marseille, 13253, France|Research Site, Perpignan Cedex, 66046, France|Research Site, Erfurt, 99089, Germany|Research Site, Budapest, 1076, Hungary|Research Site, Budapest, 1106, Hungary|Research Site, Esztergom, 2500, Hungary|Research Site, Kecskemet, 6000, Hungary|Research Site, Miskolc, 3526, Hungary|Research Site, Zalaegerszeg, 8900, Hungary|Research Site, Jerusalem, 91120, Israel|Research Site, Kfar-Saba, 44281, Israel|Research Site, Tel Hashomer, 52621, Israel|Research Site, Zerifin, 70300, Israel|Research Site, Ancona, 60131, Italy|Research Site, Lecco, 23900, Italy|Research Site, Milano, 20142, Italy|Research Site, Quartu Sant'Elena CA, 09045, Italy|Research Site, Amsterdam, 1081 HV, Netherlands|Research Site, Enschede, 7511 JX, Netherlands|Research Site, Rotterdam, 3079 DZ, Netherlands|Research Site, Venlo, 5912 BL, Netherlands|Research Site, Gdansk, 80-952, Poland|Research Site, Golub-Dobrzyn, 87-400, Poland|Research Site, Krakow, 31-501, Poland|Research Site, Lodz, 90-153, Poland|Research Site, Rybnik, 44-200, Poland|Research Site, Warszawa, 04-749, Poland|Research Site, Moscow, 123183, Russian Federation|Research Site, Saint Petersburg, 197110, Russian Federation|Research Site, Yaroslavl, 150062, Russian Federation|Research Site, Cordoba, Andalucía, 14004, Spain|Research Site, Granada, Andalucía, 18012, Spain|Research Site, Barcelona, Cataluña, 08035, Spain|Research Site, Barcelona, Cataluña, 08036, Spain|Research Site, Majadahonda, Madrid, 28222, Spain|Research Site, Karlstad, 651 85, Sweden|Research Site, Stockholm, 141 86, Sweden|Research Site, Uppsala, 751 85, Sweden
URL: https://clinicaltrials.gov/show/NCT01788046

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress