Chronic Kidney Disease Clinical Trial
Official title:
A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism
| Verified date | July 2019 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
| Status | Completed |
| Enrollment | 683 |
| Est. completion date | January 8, 2015 |
| Est. primary completion date | November 12, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - Eligible subjects must be receiving adequate thrice weekly maintenance hemodialysis with a dialysate calcium concentration = 2.5 mEq/L for at least 3 months prior to screening laboratory assessments - Subjects must have SHPT as defined by one central laboratory screening predialysis serum PTH value > 500 pg/mL, measured on separate days within 2 weeks prior to randomization - Subjects must have one serum cCa value = 8.3 mg/dL obtained before dialysis within 2 weeks of the date of randomization - Subjects receiving calcium supplements must have no more than a maximum dose change of 50% within 2 weeks before screening laboratory assessments are obtained, and the dose must remain unchanged through randomization Exclusion Criteria: - Eligible subjects cannot have received cinacalcet during the 3 months preceding the first screening laboratory assessment - Other criteria may apply |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Research Site | Feldkirch | |
| Austria | Research Site | Linz | |
| Austria | Research Site | Wien | |
| Belgium | Research Site | Genk | |
| Belgium | Research Site | Hasselt | |
| Belgium | Research Site | Kortrijk | |
| Belgium | Research Site | Roeselare | |
| Canada | Research Site | Brampton | Ontario |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Greenfield Park | Quebec |
| Canada | Research Site | Saint John | New Brunswick |
| Canada | Research Site | St. Johns | Newfoundland and Labrador |
| Czechia | Research Site | Novy Jicin | |
| Czechia | Research Site | Praha 4 - Nusle | |
| Czechia | Research Site | Praha 6 | |
| Czechia | Research Site | Slavkov u Brna | |
| Czechia | Research Site | Trinec | |
| Czechia | Research Site | Usti nad Orlici | |
| Denmark | Research Site | Aalborg | |
| Denmark | Research Site | Fredericia | |
| Denmark | Research Site | Kobenhavn | |
| Denmark | Research Site | Odense | |
| Denmark | Research Site | Roskilde | |
| Estonia | Research Site | Tallinn | |
| Estonia | Research Site | Tallinn | |
| Estonia | Research Site | Tartu | |
| France | Research Site | Boulogne sur Mer | |
| France | Research Site | Lille Cedex | |
| France | Research Site | Nouilly | |
| France | Research Site | Paris | |
| France | Research Site | Paris | |
| France | Research Site | Saint Ouen | |
| France | Research Site | Saint Priest en Jarez | |
| France | Research Site | Saint-Ouen | |
| France | Research Site | Sainte Foy les Lyon | |
| Germany | Research Site | Aachen | |
| Germany | Research Site | Coburg | |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Hannover | |
| Germany | Research Site | Magdeburg | |
| Germany | Research Site | Mettmann | |
| Germany | Research Site | Minden | |
| Germany | Research Site | München | |
| Germany | Research Site | Wiesbaden | |
| Germany | Research Site | Zwickau | |
| Greece | Research Site | Alexandroupoli | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Ioannina | |
| Greece | Research Site | Larissa | |
| Greece | Research Site | Nikaia, Piraeus | |
| Greece | Research Site | Patra | |
| Greece | Research Site | Thessaloniki | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Gyor | |
| Hungary | Research Site | Kaposvar | |
| Hungary | Research Site | Kistarcsa | |
| Hungary | Research Site | Pecs | |
| Hungary | Research Site | Pecs | |
| Hungary | Research Site | Szekesfehervar | |
| Hungary | Research Site | Szigetvar | |
| Hungary | Research Site | Zalaegerszeg | |
| Italy | Research Site | Cagliari | |
| Italy | Research Site | Firenze | |
| Italy | Research Site | Genova | |
| Italy | Research Site | Lecco | |
| Italy | Research Site | Lucca | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Pavia | |
| Italy | Research Site | Pisa | |
| Italy | Research Site | Pordenone | |
| Italy | Research Site | San Giovanni Rotondo FG | |
| Latvia | Research Site | Riga | |
| Latvia | Research Site | Riga | |
| Latvia | Research Site | Valmiera | |
| Lithuania | Research Site | Alytus | |
| Lithuania | Research Site | Kaunas | |
| Lithuania | Research Site | Kaunas | |
| Lithuania | Research Site | Kedainiai | |
| Lithuania | Research Site | Klaipeda | |
| Lithuania | Research Site | Siauliai | |
| Lithuania | Research Site | Ukmerge | |
| New Zealand | Research Site | Hamilton | |
| New Zealand | Research Site | Papatoetoe, Auckland | |
| New Zealand | Research Site | Takapuna, Auckland City | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Katowice | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Sieradz | |
| Poland | Research Site | Wadowice | |
| Poland | Research Site | Warsawa | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Zabrze | |
| Poland | Research Site | Zyrardow | |
| Portugal | Research Site | Almada | |
| Portugal | Research Site | Aveiro | |
| Portugal | Research Site | Estoril | |
| Portugal | Research Site | Forte Da Casa | |
| Portugal | Research Site | Guimarães | |
| Portugal | Research Site | Lisboa | |
| Portugal | Research Site | Santo Tirso | |
| Portugal | Research Site | Setubal | |
| Portugal | Research Site | Vila Franca de Xira | |
| Russian Federation | Research Site | Mitishi | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Petrozavodsk | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Yaroslavl | |
| Spain | Research Site | Badajoz | Extremadura |
| Spain | Research Site | Badalona | Cataluña |
| Spain | Research Site | Cordoba | Andalucía |
| Spain | Research Site | Galdakao | País Vasco |
| Spain | Research Site | Lleida | Cataluña |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Pamplona | Navarra |
| Spain | Research Site | Puerto Real | Andalucía |
| Spain | Research Site | Torrevieja | Comunidad Valenciana |
| Spain | Research Site | Valencia | Comunidad Valenciana |
| Sweden | Research Site | Malmö | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Trollhättan | |
| Switzerland | Research Site | Aarau | |
| Switzerland | Research Site | Bern | |
| Switzerland | Research Site | Geneva 14 | |
| Switzerland | Research Site | Lausanne | |
| Switzerland | Research Site | Lausanne | |
| Switzerland | Research Site | Locarno | |
| Switzerland | Research Site | Zurich | |
| Turkey | Research Site | Ankara | |
| Turkey | Research Site | Ankara | |
| Turkey | Research Site | Ankara | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Izmir | |
| Turkey | Research Site | Izmir | |
| Turkey | Research Site | Izmir | |
| United States | Research Site | Arvada | Colorado |
| United States | Research Site | Aurora | Colorado |
| United States | Research Site | Azusa | California |
| United States | Research Site | Bakersfield | California |
| United States | Research Site | Bakersfield | California |
| United States | Research Site | Baton Rouge | Louisiana |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Burlington | Vermont |
| United States | Research Site | Chula Vista | California |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Columbus | Mississippi |
| United States | Research Site | Covina | California |
| United States | Research Site | Fairfax | Virginia |
| United States | Research Site | Granada Hills | California |
| United States | Research Site | Great Neck | New York |
| United States | Research Site | Gulfport | Mississippi |
| United States | Research Site | Houston | Texas |
| United States | Research Site | La Mesa | California |
| United States | Research Site | La Puente | California |
| United States | Research Site | Lafayette | Louisiana |
| United States | Research Site | Longmont | Colorado |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Madison | Wisconsin |
| United States | Research Site | Mineola | New York |
| United States | Research Site | Orange | Connecticut |
| United States | Research Site | Pembroke Pines | Florida |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Pinecrest | Florida |
| United States | Research Site | Portsmouth | Virginia |
| United States | Research Site | Ridgewood | New York |
| United States | Research Site | Rosedale | New York |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Gabriel | California |
| United States | Research Site | Sewell | New Jersey |
| United States | Research Site | Southgate | Michigan |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Westminster | Colorado |
| United States | Research Site | Whittier | California |
| United States | Research Site | Wilmington | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Austria, Belgium, Canada, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, New Zealand, Poland, Portugal, Russian Federation, Spain, Sweden, Switzerland, Turkey,
Block GA, Bushinsky DA, Cheng S, Cunningham J, Dehmel B, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Moe SM, Patel UD, Silver J, Sun Y, Wang H, Chertow GM. Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial. JAMA. 2017 Jan 10;317(2):156-164. doi: 10.1001/jama.2016.19468. — View Citation
Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019. — View Citation
Myles Wolf1, Geoffrey A. Block2, Glenn M. Chertow3, Kerry Cooper4, Bruno Fouqueray4, Sharon M. Moe5, Yan Sun4, Holly Tomlin4, Marc Vervloet 6 and Rainer Oberbauer7. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2019;1-10.
Stollenwerk B, Iannazzo S, Akehurst R, Adena M, Briggs A, Dehmel B, Parfrey P, Belozeroff V. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet. Pharmacoeconomics. 2018 May;36(5):603-612. doi: 10.1007/s40273-017-0605-2. — View Citation
Stollenwerk B, Iannazzo S, Cooper K, Belozeroff V. Exploring the potential value of improved care for secondary hyperparathyroidism with a novel calcimimetic therapy. J Med Econ. 2017 Oct;20(10):1110-1115. doi: 10.1080/13696998.2017.1360309. Epub 2017 Aug 14. — View Citation
Wu B, Melhem M, Subramanian R, Chen P, Jaramilla Sloey B, Fouqueray B, Hock MB, Skiles GL, Chow AT, Lee E. Clinical Pharmacokinetics and Pharmacodynamics of Etelcalcetide, a Novel Calcimimetic for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis. J Clin Pharmacol. 2018 Jun;58(6):717-726. doi: 10.1002/jcph.1090. Epub 2018 Mar 13. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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). | ||
| Secondary | 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) | ||
| Secondary | 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 | |
| Secondary | Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (weeks 20 - 27) | ||
| Secondary | Percentage of Participants With Mean Predialysis Serum Phosphorus = 4.5 mg/dL During the Efficacy Assessment Phase | Efficacy assessment phase (weeks 20 - 27) | ||
| Secondary | 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 | |
| Secondary | 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 |
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