Phase 3
Completed N=456
Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
Anemia Associated With Chronic Kidney Disease (CKD)
Source: ClinicalTrials.gov NCT04707768 ↗
Enrolled (actual)
456
Serious AEs
44.6%
Results posted
Jan 2025
Primary outcomePrimary: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26) — -0.07; 0.14; 0.36 Grams per deciliter (g/dL)
◆ Published Evidence
Emerging
9citations · ~9 / year
Vadadustat Three Times Weekly in Patients With Anemia Due to Dialysis-Dependent CKD.
Summary
This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of anemia in hemodialysis participants.
Linked Publications (2)
-
Vadadustat Three Times Weekly in Patients With Anemia Due to Dialysis-Dependent CKD.
-
Safety and Efficacy of Vadadustat Once Daily and Three Times Weekly in Patients With Dialysis-Dependent CKD With Anemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26) |
-0.07; 0.14; 0.36 | — |
| SECONDARY Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52) |
-0.11; -0.22; 0.16 | — |
Eligibility Criteria
Inclusion Criteria
- ≥18 years of age
- Receiving chronic, outpatient in-center hemodialysis three times weekly (TIW) for end-stage kidney disease for at least 12 weeks prior to Screening Visit 1 (SV1)
- Currently maintained on Mircera® (≤250 μg/month) with at least 2 doses received within 8 weeks prior to Screening Visit 2 (SV2)
- Mean Screening hemoglobin (Hb) between 8.5 and 11.0 grams per deciliter (g/dL) (inclusive), as determined by the average of 2 Hb values measured by the central laboratory at least 4 days apart between SV1 and SV2
- Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening
- Folate and vitamin B12 measurements ≥ lower limit of normal during Screening
Exclusion Criteria
- Anemia due to a cause other than chronic kidney disease (CKD).
- Clinically meaningful bleeding event within 8 weeks prior to Baseline
- Red blood cell (RBC) transfusion within 8 weeks prior to Baseline
- Having received any doses of darbepoetin alfa (Aranesp®) within 4 weeks prior to Baseline
- Having received any doses of epoetin alfa (Epogen®) within 1 week prior to Baseline.
- Current uncontrolled hypertension.
- Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure (HF) or New York Heart Association Class IV HF, or stroke within 12 weeks prior to or during Screening.
- Known hypersensitivity to vadadustat, Mircera®, or any of their excipients.
Data sourced from ClinicalTrials.gov (NCT04707768) and the linked publication. 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.