Study of Roxadustat Conversion in Subjects Receiving Stable ESA or as Initial Anemia Treatment in Chronic Dialysis Patients
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Roxadustat
|
Drug: Roxadustat
This open-label single arm study is designed to evaluate roxadustat dosing in maintaining hemoglobin in ESRD subjects receiving chronic dialysis treatments
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects with mean Hb >= 10g/dL [Week 16-24]
- Mean hemoglobin change from baseline to average Hb from week 16-24 [Week 16-24]
Eligibility Criteria
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
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Screening hemoglobin criteria: Subjects converting from an ESA: between 9.0 to 12.0 g/dL; Subjects initiating anemia treatment: < 10.0 g/dL
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Ferritin ≥ 50 ng/mL, Transferrin saturation (TSAT) ≥ 10% at screening
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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.
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Body weight between 45.0 to 160.0 kg
Key Exclusion Criteria:
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Red blood cell (RBC) transfusion within 4 weeks prior to enrollment
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Known history of myelodysplastic syndrome or multiple myeloma
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Known hereditary hematologic disease or other known causes for anemia other than chronic kidney disease (CKD)
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Known chronic inflammatory disease that is determined by the investigator to be the primary cause of anemia
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Active or chronic gastrointestinal bleeding
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Treated with iron-chelating agents within 4 weeks prior to enrollment
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History of New York Heart Association (NYHA) Class III or IV congestive heart failure
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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
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Uncontrolled hypertension, in the opinion of the Investigator
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Diagnosis or suspicion of renal cell carcinoma as shown on renal imaging performed within 24 weeks prior to enrollment
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational Site | Englewood | Colorado | United States | 80110 |
| 2 | Investigational Site | Caldwell | Idaho | United States | 83642 |
| 3 | Investigational Site | Baton Rouge | Louisiana | United States | 70808 |
| 4 | Investigational Site | Kalamazoo | Michigan | United States | 49009 |
| 5 | Investigational Site | Tupelo | Mississippi | United States | 38801 |
| 6 | Investigational Site | Saint Ann | Missouri | United States | 63074 |
| 7 | Investigational Site | Las Vegas | Nevada | United States | 89106 |
| 8 | Investigational Site | Sugar Land | Texas | United States | 77479 |
| 9 | Investigational Site | Saint George | Utah | United States | 84790 |
Sponsors and Collaborators
- FibroGen
- AstraZeneca
Investigators
- Study Chair: Mark Eisner, FibroGen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FGCL-4592-097