| Outcome Measures: |
Primary: Incidence of adverse events, Incidence of adverse events, Up to 20 weeks|Mean change from baseline in Hb at Week 6, Mean change from baseline in Hb at Week 6, Up to 5 weeks after dosing | Secondary: Proportion of responders, during the entire study period., Responders are defined as patients whose Hb achieved ≥ 10.0 g/dL and an increase ≥ 1.0 g/dL from baseline, up to Week 20|Mean proportion of visits at which patients maintain Hb within the target range from baseline during the fixed-dose period and titration period, Target range is defined as 10.0-11.0 g/dL inclusive and an increase ≥ 1.0 g/dL., up to Week 20|Proportion of patients with a mean Hb between 10.0-11.0 g/dL inclusive during Week 14-20, Proportion of patients with a mean Hb between 10.0-11.0 g/dL inclusive during Week 14-20, at Week 14, 15, 16, 17, 18, 19, and 20|Change in Hb from baseline to the mean Hb levels over Week 14-20, Change in Hb from baseline to the mean Hb levels over Week 14-20, Baseline and at Week 14, 15, 16, 17, 18, 19, and 20|Mean Hb levels and mean change from baseline in Hb level at each visit, Mean Hb levels and mean change from baseline in Hb level at each visit, up to Week 20|Cumulative response rate over the entire study period, Response is defined as Hb \< 10.0 g/dL or an increase in hemoglobin of \<1 g/dL from baseline, up to Week 20 | Other: EPO levels and change from baseline at each visit, EPO levels and change from baseline at each visit, up to Week 20|Hepcidin levels and change from baseline at each visit, Hepcidin levels and change from baseline at each visit, up to Week 20|Iron study levels and change from baseline at each visit, Iron study levels and change from baseline at each visit, up to Week 20
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| Locations: |
US Renal Care - Pine Bluff, Pine Bluff, Arkansas, 71603, United States|North America Research Institute, Riverside, California, 92503, United States|Rocky Mountain Kidney Care, Lone Tree, Colorado, 80124, United States|Nephrology and Hypertension Specialists, Dalton, Georgia, 30720, United States|High Desert Nephrology Associates, Gallup, New Mexico, 87301, United States|Nephrology Associates of Western New York, Cheektowaga, New York, 14225, United States|Nephrology Consultants of Northwest Ohio - Toledo, Toledo, Ohio, 43613, United States|South Texas Renal Care Group - San Saba, San Antonio, Texas, 78207, United States|Clinical Advancement Center PLLC, San Antonio, Texas, 78212, United States|South Texas Renal Care Group, San Antonio, Texas, 78251, United States|The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400010, China|The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361001, China|Xiamen Branch, Zhongshan hospital affilicated to Fudan University, Xiamen, Fujian, 361004, China|Xiamen Fifth Hospital, Xiamen, Fujian, 361115, China|The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, 471039, China|Renmin Hospital of Wuhan University, Wuhan, Hunan, 430064, China|The First People's Hospital of Changzhou, Changzhou, Jiangsu, 213004, China|Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210011, China|Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215025, China|The Affiliated Zhongshan Hospital of Dalian University, Dalian, Liaoning, 116001, China|Zhongshan Hospital affiliated to Fudan University, Shanghai, Shanghai, 200031, China|Jinshan Hospital Affiliated to Fudan University, Shanghai, Shanghai, 201508, China|First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, 710063, China|Sichuan Provincial People's Hospital, Chengdu, Sichuan, 610032, China|Zigong First People's Hospital, Zigong, Sichuan, 643000, China
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