Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis
Condition: CKD Anemia in Stable Dialysis Patients
MeSH terms: Anemia
Intervention: Epoetin Alfa; Roxadustat
Intervention description: Epoetin alfa will be administered per dose and schedule specified in the arm.; Roxadustat will be administered per dose and schedule specified in the arm.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 741.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anemia; Chronic Kidney Disease; Dialysis; hemodialysis; peritoneal dialysis; hemoglobin; End stage renal disease; Stable Dialysis; erythropoietins; erythropoiesis stimulating agent

Summary:

      The primary objective of this study is to evaluate the efficacy and safety of roxadustat
      compared with active control (epoetin alfa) for the maintenance treatment of anemia in
      participants with ESRD on dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receiving dialysis for ESRD for ≥3 months. Incident dialysis participants (under
             Amendment 1 and 2) receiving dialysis for ESRD for ≥ 2 weeks but ≤ 4 months at the
             time of randomization

          -  Participants must be on ESA for ≥ 8 weeks prior to screening; incident dialysis
             participants must be on ESA for ≥ 4 weeks prior to screening.

          -  Mean of the 3 most recent central lab Hb values during the Screening Period must be ≥
             9.0 g/dL and ≤ 12.0 g/dL (for incident dialysis participants, mean of the 2 most
             recent Hb values must be ≥ 8.5 g/dL and ≤ 12.0 g/dL); with an absolute difference of ≤
             1.3 g/dL between the highest and the lowest value. Samples are obtained at least 4
             days apart (2 days under Amendment 2) and the last Hb value must be within 10 days
             prior to the randomization visit

          -  Participants with ferritin level ≥ 100 nanograms (ng)/milliliter (mL) (<100 ng/mL
             under Amendment 2) or transferrin saturation (TSAT) ≥ 20% (<20% under Amendment 2) at
             screening may qualify upon receiving iron supplement (per local standard of care)

          -  Participants with a serum folate and Vitamin B12 ≥ lower limit of normal (LLN) (< LLN
             under Amendment 2) at screening may qualify upon receiving supplement (per local
             standard of care)

          -  Participant's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are
             ≤3x the upper limit of normal (ULN), and total bilirubin (TBL) is ≤1.5x ULN at
             screening

          -  Participant's body weight is 45 kilograms (kg) to 160 kg.

        Exclusion Criteria:

          -  Participant has received an red blood cell (RBC) transfusion within 8 weeks (4 weeks
             under Amendment 2) prior to randomization

          -  Participant has known history of myelodysplastic syndrome or multiple myeloma

          -  Participant has known inherited disease such as thalassemia or sickle cell anemia or
             other known causes for anemia other than chronic kidney disease.

          -  Participant has known hemosiderosis, hemochromatosis, coagulation disorder,or
             hypercoagulable condition

          -  Participant has known chronic inflammatory disease that could cause anemia

          -  Participant has anticipated surgery that is expected to cause blood loss

          -  Participant has known gastrointestinal bleeding

          -  Participant has history of chronic liver disease (for example, chronic infectious
             hepatitis,chronic auto-immune liver disease,cirrhosis, or fibrosis of the liver)

          -  Participant with New York Heart Association (NYHA) Class III or IV congestive heart
             failure

          -  Participant has had a heart attack, stroke, seizure, or a thrombotic/thromboembolic
             event (for example, deep vein thrombosis or pulmonary embolism) within 12 weeks prior
             to participating in the study

          -  Participant has uncontrolled high blood pressure within 2 weeks prior to participating
             in the study

          -  Participant has a history of malignancy, except for the following: cancers determined
             to be cured or in remission for ≥2 years, curatively resected basal cell or squamous
             cell skin cancers, cervical cancer in situ, or resected colonic polyps.)

          -  Participant is positive for human immunodeficiency virus (HIV), Hepatitis B surface
             antigen, or anti-hepatitis C virus antibody

          -  Participant with prior organ transplant who experience rejection within 6 months or on
             high doses of immunosuppressive therapy

          -  Participant has any of the following known untreated conditions; proliferative
             diabetic retinopathy, diabetic macular edema, macular degeneration or retinal vein
             occlusion.