CKDkb: a knowledge base and platform for drug development against non-alcoholic fatty liver disease

Clinical Trial Details

Trial ID:	L0767
Source ID:	NCT01896232
Associated Drug:	Etelcalcetide
Title:	Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
Acronym:
Status:	COMPLETED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT01896232/results
Conditions:	Secondary Hyperparathyroidism\|Chronic Kidney Disease
Interventions:	DRUG: Etelcalcetide\|DRUG: Cinacalcet\|DRUG: Oral Placebo\|DRUG: Intravenous Placebo
Outcome Measures:	Primary: Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis, Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive). \| Secondary: Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase, Baseline and the efficacy assessment phase (Weeks 20 to 27, inclusive).\|Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase, Baseline and the efficacy assessment phase (Week 20 to Week 27)\|Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks, Participants completed the Nausea/Vomiting Symptom Assessment (NVSA) questionnaire daily. This questionnaire asked participants to indicate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined) and if they had vomited in the past 24 hours. A day of vomiting or nausea was defined as those where the severity of nausea score was \> 0 or where the episodes of vomiting score was \> 0., First 8 weeks\|Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase, Baseline and the efficacy assessment phase (weeks 20 - 27)\|Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase, Efficacy assessment phase (weeks 20 - 27)\|Mean Severity of Nausea in the First 8 Weeks, Severity of nausea was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asked participants to rate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined). For each participant, the mean severity of nausea was calculated by averaging all available daily severities (including zeroes) reported in the first 8 weeks., First 8 weeks\|Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks, The number of vomiting episodes was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asks participants on a daily basis how many times they vomited in the past 24 hours. The number of episodes in a week is the sum of all reported daily episodes in the week. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis., First 8 weeks
Sponsor/Collaborators:	Sponsor: Amgen
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE3
Enrollment:	683
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date:	2013-08-13
Completion Date:	2015-01-08
Results First Posted:	2017-02-08
Last Update Posted:	2019-07-18
Locations:	Research Site, Azusa, California, 91702, United States\|Research Site, Bakersfield, California, 93306, United States\|Research Site, Bakersfield, California, 93309, United States\|Research Site, Chula Vista, California, 91910, United States\|Research Site, Covina, California, 91723, United States\|Research Site, Granada Hills, California, 91344, United States\|Research Site, La Mesa, California, 91942, United States\|Research Site, La Puente, California, 91744, United States\|Research Site, Los Angeles, California, 90022, United States\|Research Site, San Diego, California, 92123, United States\|Research Site, San Gabriel, California, 91776, United States\|Research Site, Whittier, California, 90603, United States\|Research Site, Arvada, Colorado, 80002, United States\|Research Site, Aurora, Colorado, 80045, United States\|Research Site, Longmont, Colorado, 80501, United States\|Research Site, Westminster, Colorado, 80031, United States\|Research Site, Orange, Connecticut, 06477, United States\|Research Site, Pembroke Pines, Florida, 33028, United States\|Research Site, Pinecrest, Florida, 33156, United States\|Research Site, Tampa, Florida, 33614, United States\|Research Site, Baton Rouge, Louisiana, 70808, United States\|Research Site, Lafayette, Louisiana, 70501, United States\|Research Site, Southgate, Michigan, 48195, United States\|Research Site, Columbus, Mississippi, 39705, United States\|Research Site, Gulfport, Mississippi, 39501, United States\|Research Site, Sewell, New Jersey, 08080, United States\|Research Site, Bronx, New York, 10461, United States\|Research Site, Great Neck, New York, 11021, United States\|Research Site, Mineola, New York, 11501, United States\|Research Site, Ridgewood, New York, 11385, United States\|Research Site, Rosedale, New York, 11422, United States\|Research Site, Wilmington, North Carolina, 28401, United States\|Research Site, Cincinnati, Ohio, 45206, United States\|Research Site, Columbus, Ohio, 43215, United States\|Research Site, Philadelphia, Pennsylvania, 19106, 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, Portsmouth, Virginia, 23704, United States\|Research Site, Madison, Wisconsin, 53713, United States\|Research Site, Feldkirch, 6807, Austria\|Research Site, Linz, 4010, Austria\|Research Site, Wien, 1220, Austria\|Research Site, Genk, 3600, Belgium\|Research Site, Hasselt, 3500, Belgium\|Research Site, Kortrijk, 8500, Belgium\|Research Site, Roeselare, 8800, 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, Novy Jicin, 741 01, 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, Usti nad Orlici, 562 18, Czechia\|Research Site, Aalborg, 9000, Denmark\|Research Site, Fredericia, 7000, Denmark\|Research Site, Kobenhavn, 2100, Denmark\|Research Site, Odense, 5000, Denmark\|Research Site, Roskilde, 4000, Denmark\|Research Site, Tallinn, 10617, Estonia\|Research Site, Tallinn, 13419, Estonia\|Research Site, Tartu, 51014, Estonia\|Research Site, Boulogne sur Mer, 62200, France\|Research Site, Lille Cedex, 59800, France\|Research Site, Nouilly, 57645, France\|Research Site, Paris, 75011, France\|Research Site, Paris, 75014, France\|Research Site, Saint Ouen, 93400, France\|Research Site, Saint Priest en Jarez, 42270, France\|Research Site, Saint-Ouen, 93400, France\|Research Site, Sainte Foy les Lyon, 66046, France\|Research Site, Aachen, 52074, Germany\|Research Site, Coburg, 96450, Germany\|Research Site, Hamburg, 22297, Germany\|Research Site, Hannover, 30625, Germany\|Research Site, Magdeburg, 39120, Germany\|Research Site, Mettmann, 40822, Germany\|Research Site, Minden, 32429, Germany\|Research Site, München, 81675, Germany\|Research Site, Wiesbaden, 65191, Germany\|Research Site, Zwickau, 08060, Germany\|Research Site, Alexandroupoli, 68100, Greece\|Research Site, Athens, 11528, Greece\|Research Site, Ioannina, 45500, Greece\|Research Site, Larissa, 41110, Greece\|Research Site, Nikaia, Piraeus, 18454, Greece\|Research Site, Patra, 26500, Greece\|Research Site, Thessaloniki, 54636, Greece\|Research Site, Budapest, 1115, Hungary\|Research Site, Gyor, 9023, Hungary\|Research Site, Kaposvar, 7400, Hungary\|Research Site, Kistarcsa, 2143, 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, Cagliari, 09134, 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, San Giovanni Rotondo FG, 71013, Italy\|Research Site, Riga, 1001, Latvia\|Research Site, Riga, 1038, Latvia\|Research Site, Valmiera, 4201, Latvia\|Research Site, Alytus, 63351, Lithuania\|Research Site, Kaunas, 50009, Lithuania\|Research Site, Kaunas, 50169, Lithuania\|Research Site, Kedainiai, 57164, Lithuania\|Research Site, Klaipeda, LT-93220, Lithuania\|Research Site, Siauliai, 76299, Lithuania\|Research Site, Ukmerge, 20184, Lithuania\|Research Site, Hamilton, 3240, New Zealand\|Research Site, Papatoetoe, Auckland, 2025, New Zealand\|Research Site, Takapuna, Auckland City, 0622, New Zealand\|Research Site, Gdansk, 80-104, Poland\|Research Site, Katowice, 40-027, 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, Warsawa, 01-211, Poland\|Research Site, Warszawa, 02-507, Poland\|Research Site, Zabrze, 41-800, Poland\|Research Site, Zyrardow, 96-300, Poland\|Research Site, Almada, 2800-455, Portugal\|Research Site, Aveiro, 3800-266, Portugal\|Research Site, Estoril, 2765-294, 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, 123182, 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, 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, Yaroslavl, 150062, Russian Federation\|Research Site, Cordoba, Andalucía, 14004, Spain\|Research Site, Puerto Real, Andalucía, 11510, Spain\|Research Site, Badalona, Cataluña, 08916, 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, Pamplona, Navarra, 31008, Spain\|Research Site, Galdakao, País Vasco, 48960, Spain\|Research Site, Madrid, 28007, Spain\|Research Site, Madrid, 28040, Spain\|Research Site, Malmö, 205 02, Sweden\|Research Site, Stockholm, 118 67, Sweden\|Research Site, Trollhättan, 467 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, 06500, Turkey\|Research Site, Ankara, 06810, Turkey\|Research Site, Istanbul, 34371, Turkey\|Research Site, Istanbul, 34890, Turkey\|Research Site, Izmir, 35100, Turkey\|Research Site, Izmir, 35340, Turkey\|Research Site, Izmir, 35360, Turkey
URL:	https://clinicaltrials.gov/show/NCT01896232

Knowledge Graph
Associated Data

Drug ID	Drug Name	Type	DrugBank ID	Targets	Category	Latest Progress
D302	Cinacalcet	small molecule	DB01012				Details

Clinical Trial Details

Summary

Knowledge Graph

Associated Data

Associated NAFLD Drugs (1)