Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis
Condition: Chronic Kidney Disease; Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Roxadustat; Placebo
Intervention description: Capsule; Capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Kidney; Chronic Kidney Disease; CKD; Stage 3 or 4 Chronic Kidney Disease; Renal; Anemia; Oral anemia treatment; Hemoglobin levels; Blood count; Erythropoietin

Summary:

      The primary objective of the study is to evaluate the safety, tolerability, and
      pharmacodynamic effects of different oral doses of roxadustat administered 2 times a week
      (BIW) or 3 times a week (TIW) for up to 4 weeks to participants with chronic kidney disease
      (CKD) not requiring dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 to 80 years of age. Participants aged over 75 years but otherwise meet all other
             participant selection criteria will be evaluated on a case-by-case basis and can be
             included in this study, per discretion of Sponsor's physician representative such as
             medical monitor or clinical leader.

          2. Chronic Kidney Disease Stage 3 or 4 with hemoglobin <11.0 grams (g)/deciliter (dL).

          3. Normal iron studies.

          4. Normal folate and vitamin B12 levels.

          5. Liver function tests within normal limits at screening.

          6. Absence of active or chronic rectal bleeding.

          7. Absence of diagnosis of age-related macular degeneration (AMD), diabetic macular
             edema, or diabetic proliferative retinopathy that is likely to require treatment
             during the trial.

          8. Female participants must not be pregnant nor breastfeeding and agree to use acceptable
             method of contraception.

          9. Male participants with partners who can have children must agree to use a medically
             acceptable method of contraception.

        Exclusion Criteria:

          1. Seropositive for HIV.

          2. History of chronic liver disease.

          3. History of polycystic kidney disease (PKD).

          4. Uncontrolled hypertension (diastolic BP >110 millimeter of mercury (mmHg) or systolic
             BP >170 mmHg at screening).

          5. New York Heart Association Class III or IV congestive heart failure.

          6. Recent myocardial infarction or acute coronary syndrome.

          7. History of myelodysplastic syndrome.

          8. Any history of malignancy or a known genetic predisposition for developing cancer (for
             example, with diagnostic markers suggesting a genetic predisposition of cancer) except
             for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin,
             cervical carcinoma in situ, or resected benign colonic polyps.

          9. Active inflammatory infection or chronic inflammatory disease.

         10. Any clinically significant and uncontrolled medical condition considered a high risk
             for participation in an investigational study.

         11. Blood clots within 4 weeks.

         12. History of ongoing hemolysis or diagnosis of hemolytic syndrome.

         13. Known history of bone marrow fibrosis.

         14. History of hemosiderosis or hemochromatosis.

         15. Androgen therapy within 12 weeks.

         16. Red blood cell transfusion within 12 weeks.

         17. Therapy with an erythropoiesis stimulating agent (ESA) such as human recombinant
             erythropoietin within the past 60 days.

         18. Intravenous iron supplementation within the past 60 days.

         19. Currently taking dapsone or acetaminophen >2.6 g/day.

         20. History of prior organ transplantation.

         21. Alcohol consumption greater than 3 or more drinks per day within the past year.

         22. Use of an investigational medication or participation in an investigational study
             within 4 weeks preceding Day 1.

         23. Positive urine toxicology screen for a substance that has not been prescribed for the
             participant.