Status:
COMPLETED
Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants
Lead Sponsor:
FibroGen
Collaborating Sponsors:
AstraZeneca
Conditions:
Anemia Associated With End Stage Renal Disease (ESRD)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and effectiveness of Roxadustat dosing regimens among chronic dialysis participants converted from ESA therapy or who are ESA-naïve.
Eligibility Criteria
Inclusion
- Key
- 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 (based on central lab value; measured within 10 days prior to initiating Roxadustat treatment: Participants converting from CERA: screening heamoglobin was between 9.0 to 12.0 g/dL; Participants initiating anemia treatment: \<10.0 g/dL
- Ferritin ≥ 50 nanograms (ng)/milliliter (mL), Transferrin saturation (TSAT) ≥ 10% at screening
- Participant'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
- 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 myocardial infarction (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
Key Trial Info
Start Date :
May 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2021
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT04410198
Start Date
May 26 2020
End Date
October 11 2021
Last Update
September 13 2022
Active Locations (9)
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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