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Clinical Trial Details

Trial ID: L1694
Source ID: NCT01785849
Associated Drug: Etelcalcetide
Title: Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01785849/results
Conditions: Hyperparathyroidism, Secondary
Interventions: DRUG: Etelcalcetide|DRUG: Placebo
Outcome Measures: Primary: Percentage of Participants With a > 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 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: 508
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: 2014-06-12
Results First Posted: 2017-03-27
Last Update Posted: 2019-08-26
Locations: Research Site, Birmingham, Alabama, 35211, United States|Research Site, Pine Bluff, Arkansas, 71603, United States|Research Site, Azusa, California, 91702, United States|Research Site, Covina, California, 91723, United States|Research Site, Lakewood, California, 90712, United States|Research Site, Los Angeles, California, 90025, United States|Research Site, Lynwood, California, 90262, United States|Research Site, Northridge, California, 91324, United States|Research Site, Ontario, California, 91762, United States|Research Site, Panorama City, California, 91402, United States|Research Site, Sacramento, California, 95825, United States|Research Site, Whittier, California, 90603, United States|Research Site, Pembroke Pines, Florida, 33028, United States|Research Site, Meridian, Idaho, 83642, United States|Research Site, Evanston, Illinois, 60201, United States|Research Site, Springfield, Massachusetts, 01107, United States|Research Site, Detroit, Michigan, 48236, United States|Research Site, Kalamazoo, Michigan, 49007, United States|Research Site, Pontiac, Michigan, 48341, United States|Research Site, Southgate, Michigan, 48195, United States|Research Site, Tupelo, Mississippi, 38801, United States|Research Site, Kansas City, Missouri, 64111, United States|Research Site, Reno, Nevada, 89511, United States|Research Site, Amherst, New York, 14226, United States|Research Site, Bronx, New York, 10461, United States|Research Site, Brooklyn, New York, 11235, United States|Research Site, Rosedale, New York, 11422, United States|Research Site, Yonkers, New York, 10704, United States|Research Site, Chapel Hill, North Carolina, 27599, United States|Research Site, Durham, North Carolina, 27704, United States|Research Site, Allentown, Pennsylvania, 18104, United States|Research Site, Philadelphia, Pennsylvania, 19106, United States|Research Site, Philadelphia, Pennsylvania, 19118, United States|Research Site, Orangeburg, South Carolina, 29118, United States|Research Site, Sumter, South Carolina, 29150, United States|Research Site, Columbia, Tennessee, 38401, United States|Research Site, Nashville, Tennessee, 37205, United States|Research Site, Austin, Texas, 78758, United States|Research Site, Fort Worth, Texas, 76105, United States|Research Site, Fort Worth, Texas, 76164, United States|Research Site, Grand Prairie, Texas, 75050, United States|Research Site, Houston, Texas, 77030, United States|Research Site, Mansfield, Texas, 76063, United States|Research Site, San Antonio, Texas, 78205, United States|Research Site, San Antonio, Texas, 78215, United States|Research Site, San Antonio, Texas, 78229, United States|Research Site, Tyler, Texas, 75701, United States|Research Site, Fairfax, Virginia, 22033, United States|Research Site, Mechanicsville, Virginia, 23116, United States|Research Site, Norfolk, Virginia, 23502, United States|Research Site, Bluefield, West Virginia, 24701, United States|Research Site, Liverpool, New South Wales, 2170, Australia|Research Site, St Leonards, New South Wales, 2065, Australia|Research Site, Parkville, Victoria, 3050, Australia|Research Site, Prahan, Victoria, 3004, Australia|Research Site, Graz, 8036, Austria|Research Site, Linz, 4010, Austria|Research Site, Wien, 1090, Austria|Research Site, Aalst, 9300, Belgium|Research Site, Baudour, 7331, Belgium|Research Site, Bruxelles, 1020, Belgium|Research Site, Leuven, 3000, Belgium|Research Site, Liège, 4000, Belgium|Research Site, Brampton, Ontario, L6R 3J7, Canada|Research Site, Greenfield Park, Quebec, J4V 2H1, Canada|Research Site, Montreal, Quebec, H1T 2M4, Canada|Research Site, Quebec, G1R 2J6, Canada|Research Site, Hradec Kralove, 500 05, Czechia|Research Site, Praha 4 - Nusle, 140 00, Czechia|Research Site, Praha 6, 169 00, Czechia|Research Site, Slavkov u Brna, 684 01, Czechia|Research Site, Trinec, 739 61, Czechia|Research Site, Nantes Cedex 01, 44200, France|Research Site, Poitiers, 86021, France|Research Site, Reims Cedex, 51092, France|Research Site, Saint-Ouen, 93400, France|Research Site, Salouel Cedex 1, 80054, France|Research Site, Berlin, 12053, Germany|Research Site, Dresden, 01307, Germany|Research Site, Kiel, 24105, Germany|Research Site, Villingen-Schwenningen, 78052, Germany|Research Site, Baja, 6500, Hungary|Research Site, Budapest, 1037, Hungary|Research Site, Budapest, 1115, Hungary|Research Site, Gyor, 9023, Hungary|Research Site, Kaposvar, 7400, Hungary|Research Site, Pecs, 7624, Hungary|Research Site, Ashkelon, 78278, Israel|Research Site, Nahariya, 22100, Israel|Research Site, Tel Aviv, 64239, Israel|Research Site, Milano, 20122, Italy|Research Site, Napoli, 80131, Italy|Research Site, Pavia, 27100, Italy|Research Site, San Fermo Della Battaglia (CO), 22020, Italy|Research Site, Verona, 37126, Italy|Research Site, Bialystok, 15-540, Poland|Research Site, Warszawa, 02-006, Poland|Research Site, Warszawa, 02-097, Poland|Research Site, Warszawa, 04-141, Poland|Research Site, Wroclaw, 51-124, Poland|Research Site, Zamosc, 87-100, Poland|Research Site, Saint Petersburg, 191104, Russian Federation|Research Site, Saint Petersburg, 196247, Russian Federation|Research Site, Saint Petersburg, 198510, Russian Federation|Research Site, Saint-Petersburg, 195067, Russian Federation|Research Site, Saint-Petersburg, 195257, Russian Federation|Research Site, Santander, Cantabria, 39008, Spain|Research Site, Barcelona, Cataluña, 08003, Spain|Research Site, Barcelona, Cataluña, 08025, Spain|Research Site, Madrid, 28041, Spain|Research Site, Madrid, 28046, Spain|Research Site, Cambridge, CB2 2QQ, United Kingdom|Research Site, Coventry, CV2 2DX, United Kingdom|Research Site, Glasgow, G11 6NT, United Kingdom|Research Site, London, NW3 2QG, United Kingdom|Research Site, Nottingham, NG5 1PB, United Kingdom|Research Site, Salford, M6 8HD, United Kingdom|Research Site, Sheffield, S5 7AU, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01785849

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress