Phase 3
Completed N=1,725
Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
Anemia · Non-Dialysis-Dependent Chronic Kidney Disease
Source: ClinicalTrials.gov NCT02680574 ↗
Enrolled (actual)
1,725
Serious AEs
57.6%
Results posted
Jun 2022
Primary outcomePrimary: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) — 0.41; 0.42 Grams per deciliter (g/dL)
◆ Published Evidence
Highly cited
237citations · ~47 / year
Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD.
Summary
A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
Linked Publications (4)
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Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD.
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Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease.
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Safety Endpoints With Vadadustat Versus Darbepoetin Alfa in Patients With Non<b>-</b>Dialysis-Dependent CKD: A Post Hoc Regional Analysis of the PRO<sub>2</sub>TECT Randomized Clinical Trial of ESA-Treated Patients.
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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) |
0.41; 0.42 | — |
| PRIMARY Median Time to First Major Adverse Cardiovascular Event (MACE) |
53.21; 58.00 | =0.2015 |
| SECONDARY Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52) |
0.43; 0.44 | — |
| SECONDARY Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis |
48.29; 49.29 | =0.7770 |
| SECONDARY Median Time to First Cardiovascular MACE |
45.57; 50.29 | =0.5509 |
| SECONDARY Median Time to First Cardiovascular Death |
48.29; 54.21 | =0.4184 |
| SECONDARY Median Time to First All-cause Mortality |
57.71; 62.14 | =0.8041 |
Eligibility Criteria
Inclusion Criteria
- ≥18 years of age
- Diagnosis of chronic kidney disease (CKD) with an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) at Screening and not expected to start dialysis within 6 months of Screening
- Currently maintained on erythropoiesis-stimulating agents 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 United States (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 CKD or participant with active bleeding or recent blood loss
- Red blood cell transfusion within 8 weeks prior to randomization
- Uncontrolled hypertension
- 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 Darbepoetin or Vadadustat or to any of their excipients
Data sourced from ClinicalTrials.gov (NCT02680574) 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.