Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis
Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis
This study was conducted to explore a new therapy for anemia in participants with end stage
 renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or
 hemoglobin. Hemoglobin (which contains iron) is important for the transport of oxygen in your
 blood. The purpose of this study was to evaluate if roxadustat is effective and safe in the
 maintenance treatment of anemia in ESRD participants on stable dialysis. Roxadustat was
 compared to epoetin alfa and darbepoetin alfa, commercially available medicines for treatment
 of anemia.
This study consisted of three study periods as follows:

 -  Screening Period: up to 6 weeks

 -  Treatment Period: a minimum of 52 weeks up to a maximum of 104 weeks

 -  Follow-up Period: 4 weeks
Inclusion Criteria:

 Main Inclusion:

 -  Participant is on stable hemodialysis (HD), hemodiafiltration (HDF) or peritoneal
 dialysis (PD) treatment with the same mode of dialysis for ≥4 months prior to
 randomization.

 -  Participant is on IV or SC epoetin or IV or SC darbepoetin alfa treatment for ≥8 weeks
 prior to randomization with stable weekly doses (during 4 weeks prior to
 randomization).

 -  Mean of the participant's three most recent Hb values, as measured by central
 laboratory, during the Screening Period.

 -  Participant's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are
 ≤3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤1.5 x ULN

 Exclusion Criteria:

 Main Exclusion:

 -  Participant has received a red blood cell (RBC) transfusion within 8 weeks prior to
 randomization.

 -  Participant has a known hereditary hematologic disease such as thalassemia or sickle
 cell anemia, pure red cell aplasia, or other known causes for anemia other than
 Chronic Kidney Disease (CKD).

 -  Participant has had a myocardial infarction, acute coronary syndrome, stroke, seizure,
 or a thrombotic/thrombo-embolic event (e.g., deep vein thrombosis or pulmonary
 embolism) within 12 weeks prior to randomization.

 -  Participant has had uncontrolled hypertension, in the opinion of the investigator,
 within 2 weeks prior to randomization.

 -  Participant has a history of malignancy, except for 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.

 -  Participant has had any prior organ transplant (that has not been explanted), or
 participant is scheduled for organ transplantation.