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

Exclusion Criteria

• •1. Concurrent retinal neovascular lesions requiring treatment including proliferative diabetic retinopathy, exudative age-related macular degeneration, retinal vein occlusion, macular edema, etc.
• •2. Anemia that is possibly mainly caused by concurrent autoimmune disease with inflammatory symptoms
• •3. History of gastric/intestinal resection considered to affect the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent 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 not been medically or surgically corrected at least 4 weeks prior to first dose of study drug.
• •5. Uncontrolled hypertension defined as patients with hypertension having more than one of three diastolic blood pressure values \>95 mmHg and each test at least 5 min apart during the screening assessment.
• •6. Concurrent congestive heart failure (New York Heart Association \[NYHA\] Class III or higher).
• •7. History of stroke, transient ischemic attack, myocardial infarction, thromboembolic event, pulmonary embolism, or lung infarction within 24 weeks before the screening assessment.
• •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 anabolic steroids, testosterone enanthate, or mepitiostane within 5 weeks before the first dose.
• •12. Total bilirubin \>1.5xULN, or AST\>3xULN, or ALT\>3xULN, or ALP\>3xULN, or previous or concurrent 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 is doubt about whether to exclude or not.
• •13\. Patients that have major surgery planned during the study period. 14. Having undergone blood transfusion and/or a surgical procedure within 8 weeks before the screening assessment.
• •15\. Having undergone a kidney transplantation. 16. History of a seizure disorder or any occurrence of seizures in the past