Clinical Trial Details
| Trial ID: | L0876 |
| Source ID: | NCT03299244 |
| Associated Drug: | Etelcalcetide |
| Title: | Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT03299244/results |
| Conditions: | Secondary Hyperparathyroidism|Chronic Kidney Disease |
| Interventions: | DRUG: Etelcalcetide|DRUG: Cinacalcet |
| Outcome Measures: | Primary: Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis, Predialysis intact parathyroid hormone (iPTH) levels were measured by a central laboratory., 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 Predialysis iPTH During the Efficacy Assessment Phase, Predialysis intact parathyroid hormone levels were measured by a central laboratory., Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive).|Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis, Predialysis intact parathyroid hormone levels were measured by a central laboratory., Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive)|Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase, Predialysis corrected calcium was measured by a central laboratory., Baseline and the efficacy assessment phase (weeks 20 - 27, inclusive)|Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase, Predialysis serum phosphorus was measured by a central laboratory., Efficacy assessment phase (weeks 20 - 27, inclusive) | Other: Number of Participants With cCa < 8.3 mg/dL At Any Time During the Study, Corrected calcium was measured by the central laboratory., From first dose of study drug to end of study; up to 26 weeks + 30 days.|Number of Participants With cCa < 8.0 mg/dL At Any Time During the Study, Corrected calcium was measured by the central laboratory., From first dose of study drug to end of study; up to 26 weeks + 30 days.|Number of Participants With cCa < 7.5 mg/dL At Any Time During the Study, Corrected calcium was measured by the central laboratory., From first dose of study drug to end of study; up to 26 weeks + 30 days.|Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study, Common symptoms of hypocalcemia (diminished blood calcium) include paresthesias (fingertips, toes, or perioral), fatigue, muscle cramps, irritability or anxiety, tetany (eg, carpopedal spasm, laryngospasm), Chvostek's sign, seizures, and prolonged QT interval., From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.|Number of Participants Who Developed Antibodies to Etelcalcetide, Developing antibody incidence is defined as participants who were binding antibody positive post-baseline with a negative or no result at baseline., From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.|Number of Participants With Treatment-emergent Adverse Events, An adverse event is defined as any untoward medical occurrence in a clinical study participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment. The investigator assessed whether each adverse event was possibly related to study drug. A serious adverse event is defined as an adverse event that met at least 1 of the following serious 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, From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days. |
| Sponsor/Collaborators: | Sponsor: Amgen |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 637 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2018-05-15 |
| Completion Date: | 2020-04-08 |
| Results First Posted: | 2021-04-30 |
| Last Update Posted: | 2021-04-30 |
| Locations: | Research Site, Beijing, Beijing, 100034, China|Research Site, Lanzhou, Gansu, 730000, China|Research Site, Guangzhou, Guangdong, 510080, China|Research Site, Guangzhou, Guangdong, 510120, China|Research Site, Guangzhou, Guangdong, 510150, China|Research Site, Guangzhou, Guangdong, 510180, China|Research Site, Guangzhou, Guangdong, 510630, China|Research Site, Shenzhen, Guangdong, 518035, China|Research Site, Zhanjiang, Guangdong, 524001, China|Research Site, Nanning, Guangxi, 530021, China|Research Site, Nanning, Guangxi, 530022, China|Research Site, Zhengzhou, Henan, 450003, China|Research Site, Zhengzhou, Henan, 450052, China|Research Site, Wuhan, Hubei, 430030, China|Research Site, Wuhan, Hubei, 430034, China|Research Site, Wuhan, Hubei, 430060, China|Research Site, Changsha, Hunan, 410008, China|Research Site, Changsha, Hunan, 410011, China|Research Site, Changzhou, Jiangsu, 213003, China|Research Site, Nanjing, Jiangsu, 210009, China|Research Site, Nanjing, Jiangsu, 210029, China|Research Site, Wuxi, Jiangsu, 214023, China|Research Site, Changchun, Jilin, 130021, China|Research Site, Changchun, Jilin, 130041, China|Research Site, Dalian, Liaoning, 116001, China|Research Site, Dalian, Liaoning, 116011, China|Research Site, Dalian, Liaoning, 116027, China|Research Site, Shenyang, Liaoning, 110004, China|Research Site, Shenyang, Liaoning, 110022, China|Research Site, Xian, Shaanxi, 710004, China|Research Site, Qingdao, Shandong, 266005, China|Research Site, Shanghai, Shanghai, 200072, China|Research Site, Shanghai, Shanghai, 200090, China|Research Site, Shanghai, Shanghai, 200127, China|Research Site, Shanghai, Shanghai, 200240, China|Research Site, Taiyuan, Shanxi, 030001, China|Research Site, Chengdu, Sichuan, 610041, China|Research Site, Chengdu, Sichuan, 610072, China|Research Site, Tianjin, Tianjin, 300052, China|Research Site, Tianjin, Tianjin, 300121, China|Research Site, Urumqi, Xinjiang, 830054, China|Research Site, Hangzhou, Zhejiang, 310003, China|Research Site, Hangzhou, Zhejiang, 310009, China|Research Site, Hong Kong, Hong Kong|Research Site, Kowloon, Hong Kong|Research Site, New Territories, Hong Kong|Research Site, New Delhi, Delhi, 110 017, India|Research Site, New Delhi, Delhi, 110 025, India|Research Site, New Delhi, Delhi, 110 060, India|Research Site, New Delhi, Delhi, 110 070, India|Research Site, Ahmedabad, Gujarat, 380 006, India|Research Site, Nadiad, Gujarat, 387 001, India|Research Site, Belagavi, Karnataka, 590010, India|Research Site, Mysuru, Karnataka, 570001, India|Research Site, Kozhikode, Kerala, 673 004, India|Research Site, Kozhikode, Kerala, 673 008, India|Research Site, Chandigarh, Punjab, 160 012, India|Research Site, Chennai, Tamil Nadu, 600 006, India|Research Site, Lucknow, Uttar Pradesh, 226 014, India|Research Site, Dehradun, Uttaranchal, 248 001, India|Research Site, Wardha, 442 004, India|Research Site, Busan, 602-715, Korea, Republic of|Research Site, Busan, 602-739, Korea, Republic of|Research Site, Daegu, 700-721, Korea, Republic of|Research Site, Gumi-si, Gyeongsangbuk-do, 730-728, Korea, Republic of|Research Site, Guri-si, Gyeonggi-do, 471-701, Korea, Republic of|Research Site, Seoul, 130-872, Korea, Republic of|Research Site, Seoul, 133-817, Korea, Republic of|Research Site, Seoul, 134-727, Korea, Republic of|Research Site, Seoul, 135-720, Korea, Republic of|Research Site, Seoul, 150-950, Korea, Republic of|Research Site, Seoul, 156-707, Korea, Republic of|Research Site, Seoul, 156-755, Korea, Republic of|Research Site, Ipoh, Perak, 30450, Malaysia|Research Site, George Town, Pinang, 10990, Malaysia|Research Site, Kuching, Sarawak, 93586, Malaysia|Research Site, Batu Caves, Selangor (incl. Putrajaya), 68100, Malaysia|Research Site, Changhua, 50006, Taiwan|Research Site, Kaohsiung, 83301, Taiwan|Research Site, Keelung, 20401, Taiwan|Research Site, New Taipei, 23561, Taiwan|Research Site, Taichung, 40201, Taiwan|Research Site, Taichung, 40705, Taiwan|Research Site, Tainan, 70403, Taiwan|Research Site, Tainan, 71004, Taiwan|Research Site, Taipei, 10002, Taiwan|Research Site, Taipei, 10449, Taiwan|Research Site, Taipei, 11031, Taiwan|Research Site, Taipei, 11101, Taiwan|Research Site, Taoyuan, 33305, Taiwan |
| URL: | https://clinicaltrials.gov/show/NCT03299244 |
