This is a Phase III, randomized, open-label, active-controlled study to evaluate the safety and efficacy of AND017 in non-dialysis-dependent (NDD)-CKD patients compared with the active control, ESA treatment
A diagnosis of CKD confirmed at screening, KDOQI CKD stage 3, 4, or 5 defined by estimated Glomerular Filtration Rate (eGFR) using the CKD Epidemiology Collaboration (EPI) formula.
Not on dialysis and no clinical evidence of impending need to initiate dialysis during the study treatment.
Prior ESA and hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) treatment
ESA/HIF-PHI-naïve: Defined as no use of any ESA/HIF-PHI treatment for at least 12 weeks before randomization; Mean of the two most recent Hb values during the screening period obtained at least 7 days apart must be ≥7.5 g/dL and <10.0 g/dL with a difference of ≤1.3 g/dL between the two values;
Concurrent retinal neovascular lesions requiring treatment.
Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis or concurrent autoimmune disease with inflammatory symptoms.
History of gastric/intestinal resection considered to affect the absorption of drugs in the gastrointestinal tract or concurrent symptomatic gastroparesis despite being on treatment.
Uncontrolled hypertension, defined as patients with hypertension having more than one of three systolic blood pressure >180 mmHg, or diastolic blood pressure >110 mmHg during the screening assessment
Parallel
AND017
DrugAND017 capsules administered orally with a starting dose of 8 mg TIW for ESA naive patients or 10 mg TIW for ESA treated patients
ESA
DrugESA injection and dose based on package insert and local practice
Evaluate the efficacy of AND017 compared with the active control in maintaining Hemoglobin (Hb) levels in patients with anemia due to CKD
The mean Hb levels averaged over Week 23-27
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; for participants with baseline Hb \< 9.0 g/dL, an increase in Hb from baseline ≥ 1.0 g/dL (for) during Weeks 3-27
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
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)
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
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