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Clinical Trial Details

Trial ID: L1665
Source ID: NCT01785875
Associated Drug: Etelcalcetide
Title: Extension Study of Etelcalcetide 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/NCT01785875/results
Conditions: Hyperparathyroidism, Secondary
Interventions: DRUG: Etelcalcetide
Outcome Measures: Primary: Number of Participants With Adverse Events (AEs), Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event., From first dose until 30 days after last dose; the treatment period was 52 weeks.|Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4, Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated., 52 weeks|Number of Participants Who Developed Anti-etelcalcetide Antibodies, A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported., Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit|Change From Baseline in Blood Pressure, Blood pressure (BP) values were taken post-hemodialysis assessments., Baseline and Weeks 24 and 48 | Secondary: Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase, The efficacy assessment phase (EAP) is defined as the last 6 weeks before ending treatment, which was only for participants who completed a minimum of 8 weeks of treatment with etelcalcetide. If multiple assessments were available during the EAP, values were averaged., Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment)|Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12, The efficacy assessment phase at 12 months (EAP12) was defined as the period from week 46 to 53 (inclusive). If multiple assessments were available during the EAP12, values were averaged., Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Percentage of Participants With PTH ≤ 300 pg/mL During the EAP, Baseline and the efficacy assessment phase|Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12, Week 46 to 53|Percent Change From Baseline in Mean PTH During the EAP, Baseline and the efficacy assessment phase|Percent Change From Baseline in Mean PTH During the EAP12, Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Percent Change From Baseline in Mean Corrected Calcium During the EAP, Baseline and the efficacy assessment phase|Percent Change From Baseline in Mean Corrected Calcium During the EAP12, Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP, Baseline and the efficacy assessment phase|Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12, Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Percent Change From Baseline in Mean Phosphorus During the EAP, Baseline and the efficacy assessment phase|Percent Change From Baseline in Mean Phosphorus During the EAP12, Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 891
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-07-31
Completion Date: 2015-07-01
Results First Posted: 2017-03-27
Last Update Posted: 2019-04-10
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, Bakersfield, California, 93308, United States|Research Site, Chula Vista, California, 91910, United States|Research Site, Cudahy, California, 90201, 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, Los Angeles, California, 90025, United States|Research Site, Los Angeles, California, 90048, United States|Research Site, Lynwood, California, 90262, United States|Research Site, Northridge, California, 91324, United States|Research Site, Norwalk, California, 90650, United States|Research Site, Ontario, California, 91762, United States|Research Site, Riverside, California, 92501, United States|Research Site, San Gabriel, California, 91776, United States|Research Site, Simi Valley, California, 93065, United States|Research Site, Whittier, California, 90603, United States|Research Site, Arvada, Colorado, 80002, United States|Research Site, Denver, Colorado, 80230, United States|Research Site, Stamford, Connecticut, 06902, United States|Research Site, Coral Springs, Florida, 33071, United States|Research Site, Lauderdale Lakes, Florida, 33313, United States|Research Site, Miami, Florida, 33150, United States|Research Site, Miami, Florida, 33173, United States|Research Site, Ocala, Florida, 34471, United States|Research Site, Pembroke Pines, Florida, 33025, United States|Research Site, Pinecrest, Florida, 33156, United States|Research Site, Tampa, Florida, 33614, United States|Research Site, Augusta, Georgia, 30901, United States|Research Site, Macon, Georgia, 31217, United States|Research Site, Meridian, Idaho, 83642, United States|Research Site, Evanston, Illinois, 60201, United States|Research Site, Gurnee, Illinois, 60031, United States|Research Site, Merrillville, Indiana, 46410, United States|Research Site, Michigan City, Indiana, 46360, United States|Research Site, Wichita, Kansas, 67214-2998, United States|Research Site, Baton Rouge, Louisiana, 70808, United States|Research Site, Lafayette, Louisiana, 70503, United States|Research Site, Shreveport, Louisiana, 71101, United States|Research Site, Springfield, Massachusetts, 01107, United States|Research Site, Detroit, Michigan, 48202, 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, Brookhaven, Mississippi, 39601, United States|Research Site, Columbus, Mississippi, 39705, United States|Research Site, Gulfport, Mississippi, 39501, United States|Research Site, Tupelo, Mississippi, 38801, United States|Research Site, Kansas City, Missouri, 64111, United States|Research Site, Saint Louis, Missouri, 63136, United States|Research Site, Lincoln, Nebraska, 68510, United States|Research Site, Las Vegas, Nevada, 89106, United States|Research Site, Reno, Nevada, 89511, United States|Research Site, Portsmouth, New Hampshire, 03801, United States|Research Site, Eatontown, New Jersey, 07724, United States|Research Site, Bronx, New York, 10461, United States|Research Site, Brooklyn, New York, 11212, United States|Research Site, Brooklyn, New York, 11235, United States|Research Site, Great Neck, New York, 11021, United States|Research Site, Orchard Park, New York, 14127, United States|Research Site, Ridgewood, New York, 11385, United States|Research Site, Rosedale, New York, 11422, United States|Research Site, Yonkers, New York, 10704, United States|Research Site, Carrboro, North Carolina, 27510, United States|Research Site, Charlotte, North Carolina, 28207, United States|Research Site, Durham, North Carolina, 27704, United States|Research Site, New Bern, North Carolina, 28562, United States|Research Site, Cincinnati, Ohio, 45206, United States|Research Site, Oklahoma City, Oklahoma, 73116, United States|Research Site, Bethlehem, Pennsylvania, 18017, United States|Research Site, Philadelphia, Pennsylvania, 19106, United States|Research Site, Philadelphia, Pennsylvania, 19118, United States|Research Site, Columbia, South Carolina, 29203, United States|Research Site, Orangeburg, South Carolina, 29118, United States|Research Site, Chattanooga, Tennessee, 37408, United States|Research Site, Columbia, Tennessee, 38401, United States|Research Site, Knoxville, Tennessee, 37923, United States|Research Site, Nashville, Tennessee, 37205, United States|Research Site, Arlington, Texas, 76015, United States|Research Site, Austin, Texas, 78758, United States|Research Site, Edinburg, Texas, 78539, United States|Research Site, Fort Worth, Texas, 76104, 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, 77004, United States|Research Site, Houston, Texas, 77054, United States|Research Site, Lubbock, Texas, 79430, 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, Alexandria, Virginia, 22304, United States|Research Site, Alexandria, Virginia, 22306, United States|Research Site, Fairfax, Virginia, 22033, United States|Research Site, Hampton, Virginia, 23666, 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, 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, Parkville, Victoria, 3050, 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, Bonheiden, 2820, Belgium|Research Site, Brussels, 1200, Belgium|Research Site, Brussel, 1090, Belgium|Research Site, Bruxelles, 1020, Belgium|Research Site, Leuven, 3000, Belgium|Research Site, Liege, 4000, Belgium|Research Site, Liège, 4000, Belgium|Research Site, Roeselare, 8800, Belgium|Research Site, Tournai, 7500, Belgium|Research Site, Edmonton, Alberta, T6G 2B7, Canada|Research Site, Brampton, Ontario, L6R 3J7, Canada|Research Site, Greenfield Park, Quebec, J4V 2H1, Canada|Research Site, Montreal, Quebec, H1T 2M4, Canada|Research Site, Montreal, Quebec, H4J 1C5, Canada|Research Site, Hradec Kralove, 500 05, Czechia|Research Site, Novy Jicin, 741 01, Czechia|Research Site, Plzen, 301 00, Czechia|Research Site, Praha 4 - Nusle, 140 00, Czechia|Research Site, Praha 4, 140 21, Czechia|Research Site, Praha 6, 169 00, Czechia|Research Site, Slavkov u Brna, 684 01, Czechia|Research Site, Usti nad Orlici, 562 18, Czechia|Research Site, Bordeaux Cedex, 33076, France|Research Site, Caen, 14000, France|Research Site, La Tronche cedex, 38701, France|Research Site, Marseille cedex 5, 13385, France|Research Site, Marseille, 13253, France|Research Site, Poitiers, 86021, France|Research Site, Reims Cedex, 51092, France|Research Site, Saint-Ouen, 93400, France|Research Site, Berlin, 12053, Germany|Research Site, Dresden, 01307, Germany|Research Site, Erfurt, 99089, Germany|Research Site, Villingen-Schwenningen, 78052, Germany|Research Site, Baja, 6500, Hungary|Research Site, Budapest, 1037, Hungary|Research Site, Budapest, 1076, Hungary|Research Site, Budapest, 1106, Hungary|Research Site, Esztergom, 2500, Hungary|Research Site, Gyor, 9023, Hungary|Research Site, Kaposvar, 7400, Hungary|Research Site, Kecskemet, 6000, Hungary|Research Site, Miskolc, 3526, Hungary|Research Site, Pecs, 7624, Hungary|Research Site, Zalaegerszeg, 8900, Hungary|Research Site, Ashkelon, 78278, Israel|Research Site, Jerusalem, 91120, Israel|Research Site, Kfar-Saba, 44281, Israel|Research Site, Nahariya, 22100, Israel|Research Site, Tel Aviv, 64239, 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, 20122, Italy|Research Site, Milano, 20142, Italy|Research Site, Pavia, 27100, Italy|Research Site, Verona, 37126, 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, Bialystok, 15-540, Poland|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, 02-006, Poland|Research Site, Warszawa, 02-097, Poland|Research Site, Warszawa, 04-749, Poland|Research Site, Zamosc, 87-100, Poland|Research Site, Moscow, 123183, Russian Federation|Research Site, Saint Petersburg, 191104, Russian Federation|Research Site, Saint Petersburg, 196247, Russian Federation|Research Site, Saint Petersburg, 197110, 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, Yaroslavl, 150062, Russian Federation|Research Site, Cordoba, Andalucía, 14004, Spain|Research Site, Santander, Cantabria, 39008, Spain|Research Site, Barcelona, Cataluña, 08003, Spain|Research Site, Barcelona, Cataluña, 08025, Spain|Research Site, Barcelona, Cataluña, 08035, Spain|Research Site, Barcelona, Cataluña, 08036, Spain|Research Site, Majadahonda, Madrid, 28222, Spain|Research Site, Madrid, 28041, Spain|Research Site, Karlstad, 651 85, Sweden|Research Site, Stockholm, 141 86, Sweden|Research Site, Uppsala, 751 85, Sweden|Research Site, Cambridge, CB2 2QQ, United Kingdom|Research Site, Coventry, CV2 2DX, United Kingdom|Research Site, London, NW3 2QG, United Kingdom|Research Site, Nottingham, NG5 1PB, United Kingdom|Research Site, Sheffield, S5 7AU, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01785875

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress