A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis

• Status: Completed
• Trial end date: 2018-09-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FibroGen
• Collaborators: Astellas Pharma Europe B.V.; AstraZeneca

Criteria

Inclusion Criteria:

• Chronic kidney disease Stages 3, 4, or 5 and not receiving dialysis

• Anemia qualified by measurements of hemoglobin values during screening

• Additional blood work must be in a safe range for study entry

• Body weight 45 to 160 kilograms (kg)

• Willingness to use contraception if of child-bearing potential

Exclusion Criteria:

• Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to study participation

• More than 1 dose of intravenous iron within 12 weeks prior to study participation

• Blood transfusion within 8 weeks prior to study participation

• Active infection

• Chronic liver disease

• Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot

• Uncontrolled blood pressure within 2 weeks prior to study participation

• Renal cell carcinoma

• History of malignancy, including multiple myeloma or other myelodysplastic syndrome

• Chronic inflammatory disease that could impact red blood cell production

• Any prior organ transplant or a scheduled organ transplantation

• Anticipated elective surgery that is expected to lead to significant blood loss or anticipated elective heart procedure

• Gastrointestinal bleeding

• Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)

• Recent use of an investigational drug or treatment, or participation in an investigational study