Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants
Condition: Anemia Associated With End Stage Renal Disease (ESRD)
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: 203.0
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 chronic dialysis participants converted from 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 tunneled catheter

          -  Screening hemoglobin criteria (based on central lab value; measured within 10 days
             prior to initiating Roxadustat treatment: Participants converting from CERA: screening
             heamoglobin was between 9.0 to 12.0 g/dL; Participants initiating anemia treatment:
             <10.0 g/dL

          -  Ferritin ≥ 50 nanograms (ng)/milliliter (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 (MI), 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

          -  Diagnosis or suspicion of renal cell carcinoma as shown on renal imaging performed
             within 24 weeks prior to enrollment

          -  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