Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment
Condition: Dialysis; Anemia
MeSH terms: Anemia
Intervention: Roxadustat; Oral Iron; IV Iron
Intervention description: Tiered, weight-based dosing per schedule specified in the arm.; Administered per oral dose and schedule specified in the arm.; Administered per IV dose and schedule specified in the arm.
Intervention MeSH terms: Iron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Kidney; ESRD; Renal; End-Stage Renal Disease; Anemia; Oral anemia treatment; Hemoglobin levels; Hemodialysis; Peritoneal; HD; PD; Hb; Erythropoietin; Blood count

Summary:

      The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction
      of anemia in participants with end-stage renal disease who recently started dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receiving HD or PD for native kidney end-stage renal disease (ESRD) for 2 weeks to 4
             months, prior to randomization

          -  Mean of the 2 most recent Hb values during the screening period, obtained at least 7
             days apart, must be <10.0 grams (g)/deciliter (dL), with a difference of ≤1.0 g/dL
             between the 2 values

          -  Body weight 40 to 140 kilograms (kg)

        Exclusion Criteria:

          -  Previously received erythropoiesis-stimulating agents

          -  Received IV iron within 4 weeks of randomization

          -  Received red blood cell transfusion within 8 weeks prior to randomization or
             anticipated need for transfusion during the treatment period

          -  Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B
             surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)

          -  History of chronic liver disease

          -  Clinically significant infection

          -  New York Heart Association Class III or IV congestive heart failure

          -  History of 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 disease that could impact erythropoiesis (for example, systemic
             lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in
             remission

          -  History of other blood disorders

          -  Active hemolysis or diagnosis of hemolytic syndrome

          -  Known bone marrow fibrosis

          -  Uncontrolled or symptomatic secondary hyperparathyroidism

          -  History of alcohol or drug abuse within a year prior to randomization, or anticipated
             inability to avoid consumption of more than 3 alcoholic beverages per day

          -  History of allergy or sensitivity to oral or IV iron therapy

          -  Seizure disorder or receiving anti-epilepsy medication for seizure disorder within 12
             weeks prior to randomization

          -  Pregnant or breast-feeding females