This is a phase III, randomized, open-label, active-controlled study to evaluate the safety and efficacy of AND017 in anemic patients with End-Stage-Kidney-Disease (ESKD)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
AND017 capsules administered orally with a starting dose of 10 mg TIW
ESA injection and dose based on package insert and local practice
Fudan Univeristy Zhongshan Hospital
Shanghai, China
RECRUITINGEvaluate the efficacy of AND017 compared with the active control in maintaining Hb levels in anemic patients with ESKD
The mean Hb levels averaged over Week 23-27
Time frame: From Week 23 to Week 27
The percentage of responders
Responder is defined as: for participants with baseline Hb ≥ 9.0 g/dL, mean Hb ≥10.0 g/dL and a change from baseline ≥ -1.0 g/dL during Weeks 23-27
Time frame: From baseline to Week 27
Percentage of participants that maintained Hb level over target lower limit
Percentage of participants with mean Hb ≥ 10.0 g/dL averaged over Weeks 5-27
Time frame: From Week 5 to Week 27
Maintenance of Hb within 10.0-12.0 g/dL after initial achievement ≥10.0 g/dL during the entire study treatment period.
During entire study treatment period, the percentage of participants in which Hb, after first reaching ≥ 10.0 g/dL, is maintained within the target range of 10.0-12.0 g/dL (inclusive)
Time frame: From baseline to Week 53
Incidence of extreme Hb levels of ≥13.0 g/dL or <7.5 g/dL during the entire study treatment period
During the entire study treatment period, the percentage of participants in which Hb is ≥ 13.0 g/dL or \< 7.5 g/dL
Time frame: From baseline to Week 53
Incidence of excessive erythropoiesis
During the entire study treatment period, the percentage of participants with an Hb increase ≥ 1.0 g/dL within any 2-week period and an Hb increase ≥ 2.0 g/dL within any 4-week period respectively
Time frame: From baseline to Week 53
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The cumulative incidence of Hb non-response
The cumulative incidence of Hb non-response is defined as Hb \< 10.0 g/dL and an increase from baseline \< 1.0 g/dL averaged over Weeks 5-27
Time frame: From baseline to Week 27
Mean Hb change from baseline averaged over Weeks 5-27
Mean Hb change from baseline averaged over Weeks 5-27
Time frame: From baseline to Week 27
Mean Hb change from baseline averaged over Weeks 23-27
Mean Hb change from baseline averaged over Weeks 23-27
Time frame: From baseline to Week 27
Mean Hb change from baseline averaged over Weeks 13-17
Mean Hb change from baseline averaged over Weeks 13-17
Time frame: From baseline to Week 17
Mean Hb change from baseline averaged over Weeks 27-53
Mean Hb change from baseline averaged over Weeks 27-53
Time frame: From baseline to Week 53
Mean Hb change from baseline averaged over Weeks 49-53
Mean Hb change from baseline averaged over Weeks 49-53
Time frame: Mean Hb change from baseline averaged over Weeks 49-53
During the entire treatment period, mean Hb at each visit
During the entire treatment period, mean Hb at each visit
Time frame: From baseline to Week 53
The use of intravenous iron during the entire study treatment period
The percentage of participants that have received intravenous iron during the entire study treatment period
Time frame: From baseline to Week 53
The mean weekly dose of intravenous iron during the entire treatment period
The mean weekly dose of intravenous iron during the entire treatment period
Time frame: From baseline to Week 53
The time to first initiation of intravenous iron during the entire treatment period
The time to first initiation of intravenous iron during the entire treatment period
Time frame: From baseline to Week 53