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)

Inclusion Criteria

Informed consent • Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses.

Type of patient and disease characteristics

At Visit 1 prior to screening

Dialysis patients:

• Patients receiving hemodialysis (HD) or peritoneal dialysis (PD) for treatment of end-stage renal disease (ESRD) for at least 12 weeks. Patients treated with HD must have access consisting of an arteriovenous (AV) fistula, AV graft, or tunneled (permanent) catheter. Patients on PD must have a functioning PD catheter in place.
• Hemodialysis patients should be on 3x/week dialysis with evidence of achievement of adequate dialysis as defined by standardized Kt/V ≥2.1 in HD, and total (renal + PD) weekly Kt/V ≥1.7 in PD documented twice during the 16 weeks preceding screening for the study.
• Patients should be on a stable rHuEPO dose as defined by change in rHuEPO dose, not exceeding 20% within 4 weeks prior to screening.

Non-dialysis patients:

• Patients with estimated glomerular filtration rate (eGFR) 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 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.