Study of Roxadustat Conversion in Subjects Receiving Stable ESA or as Initial Anemia Treatment in Chronic Dialysis Patients

• Status: Active, not recruiting
• Trial end date: 2021-08-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and effectiveness of Roxadustat dosing regimens among chronic dialysis subjects converted from ESA therapy or who are ESA-naïve.

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

Details

• Lead Sponsor: FibroGen
• Collaborator: AstraZeneca

Criteria

Key Inclusion Criteria:

• Receiving chronic dialysis for end stage renal disease (ESRD)

• Vascular access must be a functioning native arteriovenous fistula or graft with adequate flow in the opinion of the investigator, or permanent tunneled catheter

• Screening hemoglobin criteria: Subjects converting from an ESA: between 9.0 to 12.0 g/dL; Subjects initiating anemia treatment: < 10.0 g/dL

• Ferritin ≥ 50 ng/mL, Transferrin saturation (TSAT) ≥ 10% at screening

• Subject's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤ 3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤ 1.5 x ULN at screening and prior to initiating roxadustat treatment.

• Body weight between 45.0 to 160.0 kg

Key Exclusion Criteria:

• Red blood cell (RBC) transfusion within 4 weeks prior to enrollment

• Known history of myelodysplastic syndrome or multiple myeloma

• Known hereditary hematologic disease or other known causes for anemia other than chronic kidney disease (CKD)

• Known chronic inflammatory disease that is determined by the investigator to be the primary cause of anemia

• Active or chronic gastrointestinal bleeding

• Treated with iron-chelating agents within 4 weeks prior to enrollment

• History of New York Heart Association (NYHA) Class III or IV congestive heart failure

• History of MI, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (excluding vascular dialysis access stenosis/thrombosis) within 12 weeks prior to enrollment

• Uncontrolled hypertension, in the opinion of the Investigator

• Diagnosis or suspicion of renal cell carcinoma as shown on renal imaging performed within 24 weeks prior to enrollment

• History of malignancy, except for cancers determined to be cured or in remission for ≥ 2 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps