Phase 3
Completed N=283
Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants
Anemia Associated With End Stage Renal Disease
Source: ClinicalTrials.gov NCT04484857 ↗
Enrolled (actual)
283
Serious AEs
29.0%
Results posted
Jul 2022
Primary outcomePrimary: Percentage of Participants With Mean Hb Value ≥10 g/dL — 83.7 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to assess the safety and effectiveness of roxadustat dosing regimens among hemodialysis participants converted from erythropoiesis stimulating agent (ESA) therapy or who are ESA-naïve.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Mean Hb Value ≥10 g/dL |
83.7 | — |
| PRIMARY Mean Hb Change From Baseline to Average Hb From Weeks 16-24 |
0.22 | — |
Eligibility 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 tunnelled catheter
- Screening Hb criteria: Participants converting from an ESA: between 9.0 to 12.0 grams (g)/deciliter (dL); Participants initiating anemia treatment: < 10.0 g/dL
- Ferritin ≥ 50 nanograms (ng)/mililiter (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 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 myocardial infarction, 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
- Participant has a diagnosis or suspicion (for example, complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma (Principal Investigator's discretion)
- 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
Data sourced from ClinicalTrials.gov (NCT04484857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.