Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment

• Status: Completed
• Trial end date: 2013-01-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FibroGen
• Collaborator: Astellas Pharma Inc
• Treatments: Iron

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