| Outcome Measures: |
Primary: Safety Evaluations, Incidence of adverse events, Up to 17 weeks|Rate of rise in hemoglobin for each of 3 dose levels as compared with placebo from baseline to 5 weeks after TIW oral dosing, Calculate the slope of a linear regression for each patient using all hemoglobin data collected during the Fixed-Dose Period, Up to 5 weeks after dosing | Secondary: Hb response to treatment during Period 1, Cumulative percentage of patients with Hb ≥10.0 g/dL, Up to 5 weeks after dosing|Percentage of responder patients, Responder is defined as a hemoglobin ≥10.0 g/dL and an increase in hemoglobin by ≥1.0 g/dL, Up to 13 weeks after dosing|Percentage of visits at which patients maintain hemoglobin between 10.0-11.0 g/dL after achieving hemoglobin ≥10.0 g/dL, Percentage of visits at which patients maintain hemoglobin between 10.0-11.0 g/dL after achieving hemoglobin ≥10.0 g/dL, Up to 13 weeks after dosing|Change from baseline in Hb, Change from baseline in Hb, Up to 13 weeks after dosing|Change in hemoglobin levels from baseline to the mean of weeks 10-13, Change in hemoglobin levels from baseline to the mean of weeks 10-13, Baseline and at Week 10, 11, 12, 13, and 14|Percentage of patients who maintain hemoglobin between 10.0-11.0g/dL at each visit, Percentage of patients who maintain hemoglobin between 10.0-11.0g/dL at each visit, Up to 13 weeks after dosing|Mean Hb levels at weeks 6-14 including the average of weeks 10-13, Mean Hb levels at weeks 6-14 including the average of weeks 10-13, Up to 13 weeks after dosing|Cumulative incidence of lack of response over the entire treatment period, Hb level \< 10.0 g/dL and an increase in hemoglobin from baseline of \< 1 g/dL, Up to13 weeks after dosing|To assess changes in the levels of PD indicator - EPO, To assess changes in the levels of EPO, Baseline and at Week 2, 4, 6, 8, 10, 12, 14, and 28 days after the last dose|To assess changes in the levels of PD indicator - hepcidin, To assess changes in the levels of hepcidin, Baseline and at Week 2, 4, 6, 8, 10, 12, 14, and 28 days after the last dose|To assess iron utilization parameter during treatment - transferrin level, To assess transferrin level during treatment, Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose|To assess iron utilization parameter during treatment - total iron-binding capacity (TIBC), To assess TIBC level during treatment, Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose|To assess iron utilization parameter during treatment - transferrin saturation (TSAT), To assess TSAT level during treatment, Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose|To assess iron utilization parameters during treatment - ferritin, To assess ferritin level during treatment, Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose|To assess iron utilization parameters during treatment - serum iron, To assess serum iron level during treatment, Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose
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| Locations: |
Amicis Research Center, Northridge, California, 91324, United States|Clinical Site Partners, Winter Park, Florida, 32789, United States|Northwest Louisiana Nephrology, Shreveport, Louisiana, 71101, United States|Elite Research Center, Flint, Michigan, 48532, United States|Metrolina Nephrology Associates, Charlotte, North Carolina, 28207, United States|Southeast Renal Research Institute, Chattanooga, Tennessee, 37404, United States|Clinical Advancement Center, PLLC, San Antonio, Texas, 78212, United States|Peking University People's Hospital, Beijing, Beijing, 100044, China
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