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Clinical Trial Details

Trial ID: L1604
Source ID: NCT02102204
Associated Drug: Etelcalcetide
Title: Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02102204/results
Conditions: Hyperparathyroidism, Secondary
Interventions: DRUG: Etelcalcetide
Outcome Measures: Primary: Number of Participants With Adverse Events, A serious adverse event is an AE that met at least 1 of the following criteria: * fatal * life threatening * required in-patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event. The relationship of each AE to study treatment was assessed by the investigator. The following AE grading scale was used: Mild: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required Moderate: Mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalization possible Life-threatening: Extreme limitation in activity, significant assistance required, significant medical intervention/therapy required, hospitalization probable., From the date of first dose of etelcalcetide (in the current study) and up to 30 days after the last dose; median duration of treatment was 563 days. | Secondary: Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal, The percentage of participants who maintained plasma parathyroid hormone (PTH) levels within the Kidney Disease Improving Global Outcomes (KDIGO) recommended range of not less than 2x the upper limit of normal (ULN) and not greater than 9x the ULN at months 6, 12, and 18, with the ULN based on the reference range of the assay used at the individual clinical site., Months 6, 12, and 18|Percentage of Participants With Serum Phosphorus ≤ the ULN, Percentage of participants with serum phosphorus less than or equal to the upper limit of normal for the assay used., Months 6, 12, and 18|Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL, The percentage of participants with serum corrected calcium (cCa) reported for cumulative time intervals from day 1 through months 6, 12, and 18, using the participant's lowest recorded corrected calcium value during the time interval. If serum albumin was less than 4.0 g/dL, serum calcium was corrected according to the following formula: cCa (mg/dL) = total calcium (mg/dL) + (4 - albumin \[g/dL\])\*0.8. If serum albumin was \> 4.0 g/dL no correction was made., From day 1 to months 6, 12, and 18|Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters, The Common Terminology Criteria for Adverse Events (CTCAE) grades for laboratory parameter values were defined based on the upper/lower limit of normal from the local laboratories contracted by the study centers., Baseline to end of treatment; median duration of treatment was 563 days.|Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies, The number of participants who were binding antibody positive post-baseline with a negative or no result at baseline (where baseline for participants previously treated with etelcalcetide is Day 1 of the first study in which they were exposed to etelcalcetide and for participants previously treated with cinacalcet is the ending time point for study 20120360)., Baseline and every 6 months (up to 24 months)
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 902
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-03-25
Completion Date: 2017-06-26
Results First Posted: 2017-11-17
Last Update Posted: 2017-11-17
Locations: Research Site, Birmingham, Alabama, 35211, United States|Research Site, Alhambra, California, 91801, United States|Research Site, Azusa, California, 91702, United States|Research Site, Bakersfield, California, 93308, United States|Research Site, Cudahy, California, 90201, United States|Research Site, Granada Hills, California, 91344, United States|Research Site, Los Angeles, California, 90022, United States|Research Site, Los Angeles, California, 90048, United States|Research Site, Northridge, California, 91324, United States|Research Site, Riverside, California, 92501, United States|Research Site, Simi Valley, California, 93065, United States|Research Site, Vacaville, California, 95687, United States|Research Site, Whittier, California, 90603, United States|Research Site, Aurora, Colorado, 80045, United States|Research Site, Westminster, Colorado, 80031, United States|Research Site, Stamford, Connecticut, 06902, United States|Research Site, Miami, Florida, 33150, United States|Research Site, Ocala, Florida, 34471, United States|Research Site, Pembroke Pines, Florida, 33028, United States|Research Site, Tampa, Florida, 33614, United States|Research Site, Augusta, Georgia, 30909, United States|Research Site, Dublin, Georgia, 31021, United States|Research Site, Meridian, Idaho, 83642, United States|Research Site, Highland Park, Illinois, 60035, 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, Springfield, Massachusetts, 01107, United States|Research Site, Detroit, Michigan, 48236, 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, Lincoln, Nebraska, 68510, United States|Research Site, Las Vegas, Nevada, 89106, United States|Research Site, Reno, Nevada, 89511, United States|Research Site, Eatontown, New Jersey, 07724, United States|Research Site, Voorhees, New Jersey, 08043, United States|Research Site, Brooklyn, New York, 11235, United States|Research Site, College Point, New York, 11356, United States|Research Site, Great Neck, New York, 11021, United States|Research Site, Mineola, New York, 11501, United States|Research Site, Rosedale, New York, 11422, United States|Research Site, The Bronx, New York, 10461, United States|Research Site, Yonkers, New York, 10704, United States|Research Site, Durham, North Carolina, 27704, United States|Research Site, New Bern, North Carolina, 28562, United States|Research Site, Wilmington, North Carolina, 28401, United States|Research Site, Cincinnati, Ohio, 45267, United States|Research Site, Columbus, Ohio, 43215, 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, 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, Edinburg, Texas, 78539, United States|Research Site, Houston, Texas, 77030, United States|Research Site, San Antonio, Texas, 78229, United States|Research Site, Burlington, Vermont, 05401, 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, Bluefield, West Virginia, 24701, United States|Research Site, Liverpool, New South Wales, 2170, 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, Prahan, Victoria, 3004, Australia|Research Site, Feldkirch, 6807, Austria|Research Site, Graz, 8036, Austria|Research Site, Linz, 4020, Austria|Research Site, Wien, 1090, Austria|Research Site, Wien, 1220, Austria|Research Site, Aalst, 9300, Belgium|Research Site, Baudour, 7331, Belgium|Research Site, Bonheiden, 2820, Belgium|Research Site, Brussels, 1200, Belgium|Research Site, Bruxelles, 1020, Belgium|Research Site, Hasselt, 3500, Belgium|Research Site, Kortrijk, 8500, 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, Saint John, New Brunswick, E2L 4L2, Canada|Research Site, St. Johns, Newfoundland and Labrador, A1B 3V6, Canada|Research Site, Brampton, Ontario, L6R 3J7, Canada|Research Site, Greenfield Park, Quebec, J4V 2H1, 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, Fredericia, 7000, Denmark|Research Site, København, 2100, Denmark|Research Site, Caen, 14000, France|Research Site, La Tronche cedex, 38701, France|Research Site, Lille Cedex, 59800, France|Research Site, Marseille, 13253, France|Research Site, Paris, 75011, France|Research Site, Paris, 75014, France|Research Site, Reims Cedex, 51092, France|Research Site, Saint Priest en Jarez, 42270, France|Research Site, Saint-Ouen, 93400, France|Research Site, Aachen, 52074, Germany|Research Site, Berlin, 12053, Germany|Research Site, Hamburg, 22297, Germany|Research Site, Langenhagen, 30853, Germany|Research Site, Minden, 32429, Germany|Research Site, München, 81675, Germany|Research Site, Villingen-Schwenningen, 78052, Germany|Research Site, Wiesbaden, 65191, Germany|Research Site, Zwickau, 08060, Germany|Research Site, Alexandroupoli, 68100, Greece|Research Site, Larissa, 41110, Greece|Research Site, Nikaia, Piraeus, 18454, Greece|Research Site, Patra, 26500, Greece|Research Site, Thessaloniki, 54636, Greece|Research Site, Baja, 6500, Hungary|Research Site, Budapest, 1106, Hungary|Research Site, Esztergom, 2500, Hungary|Research Site, Gyor, 9023, Hungary|Research Site, Kaposvar, 7400, Hungary|Research Site, Kistarcsa, 2143, Hungary|Research Site, Miskolc, 3526, Hungary|Research Site, Pecs, 7624, Hungary|Research Site, Pecs, 7633, Hungary|Research Site, Szekesfehervar, 8000, Hungary|Research Site, Szigetvar, 7900, Hungary|Research Site, Zalaegerszeg, 8900, Hungary|Research Site, Ashkelon, 78278, Israel|Research Site, Jerusalem, 91120, Israel|Research Site, Tel Aviv, 64239, Israel|Research Site, Tel Hashomer, 52621, Israel|Research Site, Zerifin, 70300, Israel|Research Site, Ancona, 60126, Italy|Research Site, Firenze, 50139, Italy|Research Site, Genova, 16132, Italy|Research Site, Lecco, 23900, Italy|Research Site, Lucca, 55100, Italy|Research Site, Milano, 20122, Italy|Research Site, Pavia, 27100, Italy|Research Site, Pisa, 56126, Italy|Research Site, Pordenone, 33170, Italy|Research Site, Verona, 37126, Italy|Research Site, Riga, 1001, Latvia|Research Site, Alytus, 63351, Lithuania|Research Site, Kaunas, 50009, Lithuania|Research Site, Kaunas, 50169, Lithuania|Research Site, Ukmerge, 20184, Lithuania|Research Site, Rotterdam, 3079 DZ, Netherlands|Research Site, Venlo, 5912 BL, Netherlands|Research Site, Hamilton, 3240, New Zealand|Research Site, Gdansk, 80-952, Poland|Research Site, Golub-Dobrzyn, 87-400, Poland|Research Site, Katowice, 40-027, Poland|Research Site, Krakow, 31-501, Poland|Research Site, Lodz, 90-153, Poland|Research Site, Poznan, 60-355, Poland|Research Site, Poznan, 61-696, Poland|Research Site, Sieradz, 98-200, Poland|Research Site, Wadowice, 34-100, Poland|Research Site, Warszawa, 02-097, Poland|Research Site, Warszawa, 02-507, Poland|Research Site, Zabrze, 41-800, Poland|Research Site, Zamosc, 87-100, Poland|Research Site, Zyrardow, 96-300, Poland|Research Site, Almada, 2800-455, Portugal|Research Site, Aveiro, 3800-266, Portugal|Research Site, Forte da Casa, 2625-437, Portugal|Research Site, Guimarães, 4810-273, Portugal|Research Site, Lisboa, 1750-130, Portugal|Research Site, Santo Tirso, 4780-383, Portugal|Research Site, Setubal, 2900-655, Portugal|Research Site, Vila Franca de Xira, 2600-076, Portugal|Research Site, Mitishi, 141009, Russian Federation|Research Site, Moscow, 129327, Russian Federation|Research Site, Petrozavodsk, 185019, 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, 193318, 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, Lleida, Cataluña, 25198, Spain|Research Site, Torrevieja, Comunidad Valenciana, 03186, Spain|Research Site, Valencia, Comunidad Valenciana, 46017, Spain|Research Site, Badajoz, Extremadura, 06080, Spain|Research Site, Majadahonda, Madrid, 28222, Spain|Research Site, Pamplona, Navarra, 31008, Spain|Research Site, Madrid, 28040, Spain|Research Site, Madrid, 28041, Spain|Research Site, Karlstad, 651 85, Sweden|Research Site, Stockholm, 118 67, Sweden|Research Site, Stockholm, 141 86, Sweden|Research Site, Trollhättan, 467 85, Sweden|Research Site, Uppsala, 751 85, Sweden|Research Site, Aarau, 5001, Switzerland|Research Site, Bern, 3010, Switzerland|Research Site, Geneva 14, 1211, Switzerland|Research Site, Lausanne, 1003, Switzerland|Research Site, Lausanne, 1011, Switzerland|Research Site, Locarno, 6600, Switzerland|Research Site, Zurich, 8091, Switzerland|Research Site, Ankara, 06230, Turkey|Research Site, Ankara, 06810, Turkey|Research Site, Istanbul, 34371, Turkey|Research Site, Istanbul, 34890, Turkey|Research Site, Izmir, 35100, Turkey
URL: https://clinicaltrials.gov/show/NCT02102204

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress