| Outcome Measures: |
Primary: Change in Hb from baseline to the average level, Change in Hb from baseline to the average level, Weeks 7 to 9 inclusive. | Secondary: The proportion of subjects who achieve a confirmed Hb response, The proportion of subjects who achieve a confirmed Hb response, up to and including Week 9|Proportion of subjects with mean Hb ≥10.0 g/dL, Proportion of subjects with mean Hb ≥10.0 g/dL, Weeks 7 to 9|Mean change from baseline in low-density lipoprotein (LDL) cholesterol averaged, Mean change from baseline in low-density lipoprotein (LDL) cholesterol averaged, Weeks 7 to 9|Effect on iron metabolism, Measurement of serum iron, Week 9|Survey (SF-36) Physical Functioning (PF) subscore measured in Week 9 in the Full Analysis Set (FAS) subjects with baseline PF subscore below 35, Survey (SF-36) Physical Functioning (PF) subscore measured in Week 9 in the Full Analysis Set (FAS) subjects with baseline PF subscore below 35, Week 9|Mean change from baseline in SF-36 vitality subscore measured in Week 9 in FAS subjects with baseline vitality subscore below 50., Mean change from baseline in SF-36 vitality subscore measured in Week 9 in FAS subjects with baseline vitality subscore below 50., Week 9|Mean change from baseline in mean arterial blood pressure, Mean change from baseline in mean arterial blood pressure, Weeks 7 to 9|Proportion of subjects who received rescue therapy (composite of blood transfusion, ESA use, and IV iron), Proportion of subjects who received rescue therapy (composite of blood transfusion, ESA use, and IV iron), Up to Week 9|Percent of subjects with treatment-emergent adverse events (TEAEs)., Percent of subjects with treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs), Week 1 up to Week 53|Number of subjects with treatment-emergent adverse events (TEAEs)., Number of subjects with treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs), Week 1 up to Week 53|Changes from baseline in vital signs, Measurement of vital signs, Week 1 up to Week 53|Changes from baseline in ECG findings, ECG recordings, Week 1 up to Week 53|Changes from baseline in clinical laboratory values, Clinical laboratory values, Week 1 up to Week 53|Proportion of subjects on rescue therapy, Proportion of subjects on rescue therapy, Week 1 up to Week 53|Time to rescue therapy from date of first dose, Time to rescue therapy from date of first dose, Week 1 up to Week 53
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| Locations: |
The Second Hospital of Anhui Medical University, Hefei, Anhui, China|301 Hospital, Beijing, Beijing, China|Peking Union Medical College Hospital, Beijing, Beijing, China|Peking University First Hospital, Beijing, Beijing, China|Pekingg University, People's Hospital, Beijing, Beijing, China|The First Affiliated hospital of Third Military Medical University (Southwest Hospital), Chongqing, Chongqing, China|Lan Zhou University Second Hospital, Lanzhou, Gansu, China|Guangdong General Hospital, Guangzhou, Guangdong, China|Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China|Shenzhen People's Hospital, Shenzhen, Guangdong, China|The First Affiliated hospital of Guangxi Medical University, Nanning, Guangxi, China|The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China|The Second Xiangya Hospital of Central South University, Changsha, Hunan, China|The First Hospital of Baotou Medical School of Inner Mongolia University of Science and Technology, Baotou, Inner Mongolia, China|Jiangsu Province Hospital, Nanjing, Jiangsu, China|Nanjing General Hospital of Nanjing Military Command, Nanjing, Jiangsu, China|Zhongda Hospital Southeast University, Nanjing, Jiangsu, China|The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China|The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China|The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China|Shandong Provincial Hospital, Jinan, Shandong, China|Huashan Hospital of Fudan University, Shanghai, Shanghai, China|Rui Jin Hospital Shanghai Jiao Tong University School of Medication, Shanghai, Shanghai, China|Shanghai Changzheng Hospital, Shanghai, Shanghai, China|Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medication, Shanghai, Shanghai, China|The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China|West China Hospital, Sichuan Universtiy, Chengdu, Sichuan, China|Tianjin Medical University General Hospital, Tianjin, Tianjin, China|The First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, China|Ningbo No.2 Hospital, Ningbo, Zhejiang, China
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