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Brief Title: Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
Official Title: A Multicenter, Multiple-dose, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet Hydrochloride With Intravenous Doses of Etelcalcetide (AMG 416) in Asian Hemodialysis Subjects With Secondary Hyperparathyroidism
Study ID: NCT03299244
Brief Summary: The primary objective is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum intact parathyroid hormone (PTH) levels by \> 30% from baseline among participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Beijing, Beijing, China
Research Site, Lanzhou, Gansu, China
Research Site, Guangzhou, Guangdong, China
Research Site, Guangzhou, Guangdong, China
Research Site, Guangzhou, Guangdong, China
Research Site, Guangzhou, Guangdong, China
Research Site, Guangzhou, Guangdong, China
Research Site, Shenzhen, Guangdong, China
Research Site, Zhanjiang, Guangdong, China
Research Site, Nanning, Guangxi, China
Research Site, Nanning, Guangxi, China
Research Site, Zhengzhou, Henan, China
Research Site, Zhengzhou, Henan, China
Research Site, Wuhan, Hubei, China
Research Site, Wuhan, Hubei, China
Research Site, Wuhan, Hubei, China
Research Site, Changsha, Hunan, China
Research Site, Changsha, Hunan, China
Research Site, Changzhou, Jiangsu, China
Research Site, Nanjing, Jiangsu, China
Research Site, Nanjing, Jiangsu, China
Research Site, Wuxi, Jiangsu, China
Research Site, Changchun, Jilin, China
Research Site, Changchun, Jilin, China
Research Site, Dalian, Liaoning, China
Research Site, Dalian, Liaoning, China
Research Site, Dalian, Liaoning, China
Research Site, Shenyang, Liaoning, China
Research Site, Shenyang, Liaoning, China
Research Site, Xian, Shaanxi, China
Research Site, Qingdao, Shandong, China
Research Site, Shanghai, Shanghai, China
Research Site, Shanghai, Shanghai, China
Research Site, Shanghai, Shanghai, China
Research Site, Shanghai, Shanghai, China
Research Site, Taiyuan, Shanxi, China
Research Site, Chengdu, Sichuan, China
Research Site, Chengdu, Sichuan, China
Research Site, Tianjin, Tianjin, China
Research Site, Tianjin, Tianjin, China
Research Site, Urumqi, Xinjiang, China
Research Site, Hangzhou, Zhejiang, China
Research Site, Hangzhou, Zhejiang, China
Research Site, Hong Kong, , Hong Kong
Research Site, Kowloon, , Hong Kong
Research Site, New Territories, , Hong Kong
Research Site, New Delhi, Delhi, India
Research Site, New Delhi, Delhi, India
Research Site, New Delhi, Delhi, India
Research Site, New Delhi, Delhi, India
Research Site, Ahmedabad, Gujarat, India
Research Site, Nadiad, Gujarat, India
Research Site, Belagavi, Karnataka, India
Research Site, Mysuru, Karnataka, India
Research Site, Kozhikode, Kerala, India
Research Site, Kozhikode, Kerala, India
Research Site, Chandigarh, Punjab, India
Research Site, Chennai, Tamil Nadu, India
Research Site, Lucknow, Uttar Pradesh, India
Research Site, Dehradun, Uttaranchal, India
Research Site, Wardha, , India
Research Site, Busan, , Korea, Republic of
Research Site, Busan, , Korea, Republic of
Research Site, Daegu, , Korea, Republic of
Research Site, Gumi-si, Gyeongsangbuk-do, , Korea, Republic of
Research Site, Guri-si, Gyeonggi-do, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Ipoh, Perak, Malaysia
Research Site, George Town, Pinang, Malaysia
Research Site, Kuching, Sarawak, Malaysia
Research Site, Batu Caves, Selangor (incl. Putrajaya), Malaysia
Research Site, Changhua, , Taiwan
Research Site, Kaohsiung, , Taiwan
Research Site, Keelung, , Taiwan
Research Site, New Taipei, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan, , Taiwan
Research Site, Tainan, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taoyuan, , Taiwan
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR