Phase 3
N=1,751
Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease
Anemia · Non-Dialysis-Dependent Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT02648347 ↗Enrolled (actual)
1,751
Serious AEs
64.9%
Results posted
Jun 2022
Primary outcome: Primary: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) — 1.43; 1.38 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vadadustat (Drug); Darbepoetin alfa (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Akebia Therapeutics
- Primary completion
- Jun 2020
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) |
1.43; 1.38 | — |
| PRIMARY Median Time to First Major Adverse Cardiovascular Event (MACE) |
45.71; 46.71 | =0.2050 |
| SECONDARY Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52) |
1.52; 1.48 | — |
| SECONDARY Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis |
37.64; 41.43 | =0.1743 |
| SECONDARY Median Time to First Cardiovascular MACE |
45.86; 41.86 | =0.3154 |
| SECONDARY Median Time to First Cardiovascular Death |
48.29; 41.86 | =0.5991 |
| SECONDARY Median Time to First All-cause Mortality |
46.57; 47.79 | =0.4388 |
Summary
A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)
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
- Mean Screening hemoglobin <10.0 grams per deciliter (g/dL)
- 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 participants with active bleeding or recent blood loss
- Red blood cell transfusion within 8 weeks prior to randomization.
- Any erythropoietic stimulating agent 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 (NCT02648347). 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.