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Clinical Trial Details

Trial ID: L0725
Source ID: NCT04885647
Associated Drug: Ypeg-Rhepo
Title: A Study of YPEG-rhEPO in Patients Suffered From Anemia Due to Chronic Kidney Disease
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Renal Anemia of Chronic Kidney Disease
Interventions: DRUG: YPEG-rhEPO|DRUG: YPEG-rhEPO|DRUG: YPEG-rhEPO|DRUG: YPEG-rhEPO
Outcome Measures: Primary: Changes of mean hemoglobin compared to baseline., 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups. | Secondary: Proportion of patients with hemoglobin keeping within the target range (the target hemoglobin range is defined as hemoglobin keeping between 100g/L and 120g/L)., 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.|Proportion of patients with hemoglobin fluctuations within ±10g/L compared to baseline., 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.|Mean time of hemoglobin keeping within the target range., 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.|Mean time from baseline to the first dose adjustment., 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.|Changes of hemoglobin compared to baseline at the time of first dose adjustment., 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.|Proportion of patients with dose adjustment., 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.|Proportion of patients requiring blood transfusion., 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Sponsor/Collaborators: Sponsor: Xiamen Amoytop Biotech Co., Ltd. | Collaborators: First Affiliated Hospital of Zhejiang University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-03-12
Completion Date: 2022-01-05
Results First Posted:
Last Update Posted: 2022-12-16
Locations: Beijing Anzhen Hospital,Capital Medical University, Beijing, Beijing, China|The Second Affiliated Hospital Of Chongqing Medical University, Chongqing, Chongqing, China|The First Affiliated Hospital Of Guangzhou Medical University, Guangzhou, Guangdong, China|The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, China|The Third Affiliated Hospital of Sun Yat sen University, Guanzhou, Guangdong, China|Renmin Hospital of Wuhan University/Hubei General Hospital, Wuhan, Hubei, China|The Third Xiangya Hospital Of Central South University, Changsha, Hunan, China|Xiangya Hospital Central South University, Changsha, Hunan, China|The First Affiliated Hospital Of Baotou Medical college,Inner Mongolia University Of Science and Technology, Hohhot, Inner Mongol, China|Huai'an Second People's Hospital/The Affiliated Huaian Hospital Of Xuzhou Medical University, Huai'an, Jiangsu, China|Affiliated Zhongshan Hospital of Dalian University, Dalian, Liaoning, China|Xi'an Gaoxin Hospital, Xi'an, Shanxi, China|The First Affiliated Hospital Of Chengdu Medical college, Chengdu, Sichuan, 361028, China|Tianjin First Central Hospital, Tianjin, Tianjin, China|Tianjin People's Hospital, Tianjin, Tianjin, China|The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China|Lishui Municipal Central Hospital, Lishui, Zhejiang, China
URL: https://clinicaltrials.gov/show/NCT04885647