Phase 3
Completed N=3,554
Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)
Anemia · Dialysis-Dependent Chronic Kidney Disease
Source: ClinicalTrials.gov NCT02892149 ↗
Enrolled (actual)
3,554
Serious AEs
56.7%
Results posted
Jun 2022
Primary outcomePrimary: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) — 0.19; 0.36 Grams per deciliter (g/dL)
◆ Published Evidence
Highly cited
195citations · ~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 maintenance treatment of anemia in participants with 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) |
0.19; 0.36 | — |
| PRIMARY Median Time to First Major Adverse Cardiovascular Event (MACE) |
48.86; 48.00 | 0.4745 |
| SECONDARY Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52) |
0.23; 0.41 | — |
| SECONDARY Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis |
43.29; 45.21 | 0.3718 |
| SECONDARY Median Time to First Cardiovascular MACE |
44.57; 43.57 | 0.3875 |
| SECONDARY Median Time to First Cardiovascular Death |
46.14; 47.64 | 0.6281 |
| SECONDARY Median Time to First All-cause Mortality |
50.79; 50.43 | 0.5811 |
Eligibility Criteria
Inclusion Criteria
- ≥18 years of age
- Receiving chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease for at least 12 weeks prior to Screening
- Currently maintained on erythropoiesis-stimulating agent therapy, with a dose received within 6 weeks prior to or during Screening
- Mean Screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive) in the US and between 9.0 and 12.0 g/dL (inclusive) outside of the US
- Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening
Exclusion Criteria
- Anemia due to a cause other than chronic kidney disease or participants with active bleeding or recent blood loss
- Uncontrolled hypertension
- Red blood cell transfusion within 8 weeks prior to randomization
- Anticipated to recover adequate kidney function to no longer require dialysis
- Severe heart failure at Screening (New York Heart Association Class IV)
- 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, or stroke within 12 weeks prior to or during Screening
- Hypersensitivity to Vadadustat, Darbepoetin alfa, or any of their excipients
Data sourced from ClinicalTrials.gov (NCT02892149) 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.