Overview

Study of Roxadustat Conversion in Subjects Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis 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 hemodialysis 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