Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants
Condition: Anemia Associated With End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Anemia
Intervention: Roxadustat
Intervention description: Roxadustat will be administered per dose and schedule specified in the arm description.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 283.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and effectiveness of roxadustat dosing
      regimens among hemodialysis participants converted from erythropoiesis stimulating agent
      (ESA) therapy or who are ESA-naïve.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Receiving chronic dialysis for end stage renal disease (ESRD)

          -  Vascular access must be a functioning native arteriovenous fistula or graft with
             adequate flow in the opinion of the investigator, or permanent tunnelled catheter

          -  Screening Hb criteria: Participants converting from an ESA: between 9.0 to 12.0 grams
             (g)/deciliter (dL); Participants initiating anemia treatment: < 10.0 g/dL

          -  Ferritin ≥ 50 nanograms (ng)/mililiter (mL), Transferrin saturation (TSAT) ≥ 10% at
             screening

          -  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 at
             screening and prior to initiating roxadustat treatment.

          -  Body weight between 45.0 to 160.0 kg

        Key Exclusion Criteria:

          -  Red blood cell (RBC) transfusion within 4 weeks prior to enrollment

          -  Known history of myelodysplastic syndrome or multiple myeloma

          -  Known hereditary hematologic disease or other known causes for anemia other than
             chronic kidney disease (CKD)

          -  Known chronic inflammatory disease that is determined by the investigator to be the
             primary cause of anemia

          -  Active or chronic gastrointestinal bleeding

          -  Treated with iron-chelating agents within 4 weeks prior to enrollment

          -  History of New York Heart Association (NYHA) Class III or IV congestive heart failure

          -  History of myocardial infarction, acute coronary syndrome, stroke, seizure, or a
             thrombotic/thromboembolic event (excluding vascular dialysis access
             stenosis/thrombosis) within 12 weeks prior to enrollment

          -  Uncontrolled hypertension, in the opinion of the Investigator

          -  Participant has a diagnosis or suspicion (for example, complex kidney cyst of Bosniak
             Category II or higher) of renal cell carcinoma (Principal Investigator's discretion)

          -  History of malignancy, except for 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