A Study of AND017 to Treat Anemia in Non-dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients

Key Inclusion Criteria:

1. Diagnosis of chronic kidney disease, not receiving dialysis, with an eGFR <60mL/min/1.73 m2.
2. Baseline Hb level ≥ 7.5 g/dL and <10.0 g/dL.
3. TSAT ≥ 20% or ferritin ≥ 100 ng/mL at screening test
4. Serum folate and vitamin B12 ≥ lower limit of normal at screening test
5. AST and ALT ≤ 3×ULN.
6. Total bilirubin ≤ 1.5×ULN.

Key Exclusion Criteria:

1. Concurrent retinal neovascular lesions requiring treatment including proliferativediabetic retinopathy, exudative age-related macular degeneration, retinal veinocclusion, macular edema, etc.
2. Anemia that is possibly mainly caused by concurrent autoimmune disease withinflammatory symptoms
3. History of gastric/intestinal resection considered to affect the absorption of drugsin the gastrointestinal tract (excluding resection of gastric or colon polyps) orconcurrent symptomatic gastroparesis despite being on treatment.
4. Clinically significant bleeding (eg, requiring transfusion or drop in Hb of ≥ 2g/dL)within 4 weeks of first dose; no bleeding diathesis or risk of bleeding that has notbeen medically or surgically corrected at least 4 weeks prior to first dose of studydrug.
5. Uncontrolled hypertension defined as patients with hypertension having more than oneof three diastolic blood pressure values >95 mmHg and each test at least 5 min apartduring the screening assessment.
6. Concurrent congestive heart failure (New York Heart Association [NYHA] Class III orhigher).
7. History of stroke, transient ischemic attack, myocardial infarction, thromboembolicevent, pulmonary embolism, or lung infarction within 24 weeks before the screeningassessment.
8. Concurrent anemia due to another cause other than renal anemia
9. Known hemosiderosis, hemochromatosis or hyper-coagulable condition
10. Any treatment with a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)within 5 weeks before randomization.
11. Having received treatment with erythropoiesis stimulating agents, androgenic anabolicsteroids, testosterone enanthate, or mepitiostane within 5 weeks before the firstdose.
12. Total bilirubin >1.5xULN, or AST>3xULN, or ALT>3xULN, or ALP>3xULN, or previous orconcurrent serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.)thought to be caused by ESAs.
13. Patients with a history of significant liver disease or active liver disease.Investigators should discuss this with the Medical Monitor for cases where there isdoubt about whether to exclude or not.
14. Patients that have major surgery planned during the study period. 14. Having undergoneblood transfusion and/or a surgical procedure within 8 weeks before the screeningassessment.
15. Having undergone a kidney transplantation. 16. History of a seizure disorder or anyoccurrence of seizures in the past