Phase 3
Completed N=369
Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)
Anemia · Dialysis-Dependent Chronic Kidney Disease
Source: ClinicalTrials.gov NCT02865850 ↗
Enrolled (actual)
369
Serious AEs
53.2%
Results posted
Jul 2022
Primary outcomePrimary: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) — 1.26; 1.58 Grams per deciliter (g/dL)
◆ Published Evidence
Highly cited
197citations · ~39 / year
Safety and Efficacy of Vadadustat for Anemia in Patients Undergoing Dialysis.
Summary
A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in participants with incident dialysis-dependent chronic kidney disease (DD-CKD).
Linked Publications (4)
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Safety and Efficacy of Vadadustat for Anemia in Patients Undergoing Dialysis.
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Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease.
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Vadadustat for treatment of anemia in patients with dialysis-dependent chronic kidney disease receiving peritoneal dialysis.
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Safety and Efficacy of Vadadustat for the Treatment of CKD-Related Anemia within and outside the United States.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) |
1.26; 1.58 | — |
| PRIMARY Median Time to First Major Adverse Cardiovascular Event (MACE) |
26.21; 46.64 | =0.9950 |
| SECONDARY Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52) |
1.42; 1.50 | — |
| SECONDARY Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis |
27.14; 47.00 | =0.8871 |
| SECONDARY Median Time to First Cardiovascular MACE |
18.50; 54.07 | =0.5210 |
| SECONDARY Median Time to First Cardiovascular Death |
22.00; 58.14 | =0.9527 |
| SECONDARY Median Time to First All-cause Mortality |
31.71; 45.36 | =0.5115 |
Eligibility Criteria
Inclusion Criteria
- ≥18 years of age
- Initiated chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease within 16 weeks prior to Screening
- Mean Screening hemoglobin between 8.0 and 7700 units/dose three times per week or >23,000 units per week
- Darbepoetin alfa: >100 micrograms per week (mcg/week)
- methoxy polyethylene glycol-epoetin beta: >100 micrograms (mcg) every other week or >200 mcg/month
- Hypersensitivity to Vadadustat, Darbepoetin alfa or any of their excipients
Data sourced from ClinicalTrials.gov (NCT02865850) 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.