A Study to Investigate the Effect of Roxadustat versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients with Anemia of Chronic Kidney Disease (CKD)

Exclusion Criteria

• Medical conditions
• • New York Heart Association Class III or IV congestive heart failure (CHF) at screening.
• • Acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (eg, deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.
• • History of severe, chronic, end-stage, or uncontrolled autoimmune liver disease with ALT 3 x ULN, or AST > 3 × ULN, or total bilirubin > 1.5 × ULN.
• • Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red-cell aplasia or other known causes for anemia other than CKD.
• • Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy.
• • Systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg (confirmed by repeated measurement), within 2 weeks prior to randomization. Patients may be rescreened once BP is controlled.
• • History of prostate cancer, breast cancer, renal cell carcinoma or any other malignancy, except the following: cancers determined to be cured or in remission for ≥5 years; curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.
• • Chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythromatosus (SLE), ankylosing spondylitis, psoriatic arthritis or active inflammatory bowel disease that is determined to be the principal cause of anemia.
• • Known hemosiderosis, hemochromatosis or hypercoagulable condition.
• • Any prior organ transplant or a scheduled organ transplantation date.
• • Any current condition leading to active significant blood loss.
• • Known allergy to the study treatment or any of its ingredients.
• • Any medical condition, including active, clinically significant infection, that in the opinion of the Investigator or Sponsor may pose a safety risk to a patient in this study, which may confound safety or efficacy assessment or may interfere with study participation.
• • Intolerance of oral iron in the past as defined by stomach upset, nausea, vomiting, or diarrhea.
• • Active GI bleed.
• • Hospitalizations within the 12 weeks preceding study randomization for GI bleeding or Congestive heart failure.
• • Life expectancy <6 months.
• • Patients who are likely to be initiated on dialysis within the next 3 months per Investigator’s assessment at the time of screening.
• • Previous bowel resection.
• • Coeliac disease.
• • Gastroenteritis in the 4 weeks prior to randomization.
• • Cognitive disabilities, physical or psychiatric disease that in the opinion of the Investigator/clinician influence the patient’s adherence and successful completion of the study.
• Prior/concomitant therapy:
• • Any treatment with roxadustat or a Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors (HIF-PHI).
• • Any red blood cells transfusion within 6 weeks prior to the first Screening Visit, or during the Screening Period.
• • Has received another new chemical entity (defined as a compound which has not been approved for marketing) within the 12 weeks prior to Screening Visit.
• • Exposure to IV iron or use of TRIFERIC® in dialysate during the Screening Period (ie, 2 weeks before randomization [Day 1]).
• • Exposure to iron-chelating agent (eg, deferoxamine/desferrioxamine, deferiprone or deferaxirox therapy) within the 6 weeks prior to the first Screening Visit.
• Prior/concurrent clinical study experience:
• • Participation in any other clinical study that included drug treatment within at least 4 weeks of screening.
• Other exclusions:
• • Involvement in the planning and/or conduct of the study (applies to AstraZeneca and FibroGen staff and/or staff at the study site).
• • Patient non-adherence to medications or missing >1 dialysis treatments/month per the Investigator’s knowledge.
• • Previous randomization in the present study.
• • History of alcohol or drug abuse within 2 years prior to randomization.