Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia

A Phase 2, Randomized, Open-Label, Dose Titration, Efficacy and Safety Study of FG-4592 (Roxadustat) in Non-Dialysis Chronic Kidney Disease Patients With Anemia

The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.

Inclusion Criteria:

1. Age 18 to 75 years
2. Chronic kidney disease, not receiving dialysis
3. Body weight 45 to 140 kg

Exclusion Criteria:

1. Any clinically significant infection or evidence of an underlying infection
2. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
3. History of chronic liver disease
4. New York Heart Association Class III or IV congestive heart failure
5. Myocardial infarction or acute coronary syndrome within 12 weeks prior to randomization
6. History of malignancy
7. Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
8. History of myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
9. History of hemosiderosis, hemochromatosis or polycystic kidney disease
10. Active hemolysis or diagnosis of hemolytic syndrome
11. Uncontrolled or symptomatic secondary hyperparathyroidism
12. Seizure disorder or receiving anti-epilepsy medication
13. Known bone marrow fibrosis
14. Any prior or scheduled organ transplant
15. Prior treatment with roxadustat or any hypoxia-inducible factor prolyl hydroxylase inhibitor
16. History of alcohol or drug abuse