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Spots Global Cancer Trial Database for Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: MD

Affiliation: Amgen

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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