Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents
NCT ID: NCT05082584
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2025-01-31
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vadadustat
Cohort 1: participants with ≥12 years to \<17 years; Cohort 2: participants with ≥6 years to \<12 years; Cohort 3(a): participants with ≥2 years to \<6 years; and Cohort 3(b): participants with ≥4 months to \<2 years
Vadadustat
Vadadustat tablet orally once a day for 52 weeks
Interventions
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Vadadustat
Vadadustat tablet orally once a day for 52 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of non-dialysis-dependent (NDD) CKD with an estimated glomerular filtration rate of greater than (\>) 10 and less than (\<) 60 milliliters/minute/1.73 meters\^2 (mL/min/1.73 m\^2 ) or diagnosis of dialysis dependent (DD) CKD
* Mean screening hemoglobin (Hb) \<10.0 grams/deciliters (g/dL)
* Transferrin Saturation ≥ 20%
Exclusion Criteria
* Active bleeding or recent clinically significant blood loss
* Treatment with an erythropoiesis-stimulating agents (ESA) within 8 weeks prior to Screening
* History of sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
* Red Blood Cells transfusion within 4 weeks
* Serum albumin level \<2.5 g/dL
* Uncontrolled hypertension
* Active malignancy or treatment for malignancy within the past 2 years prior to Screening
* Evidence of iron overload or diagnosis of hemochromatosis
* Known hypersensitivity to vadadustat or any excipients in vadadustat tablet
4 Months
16 Years
ALL
No
Sponsors
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Akebia Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Akebia Therapeutics Inc.
Locations
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Research Site
Hackensack, New Jersey, United States
Countries
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Other Identifiers
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AKB-6548-CI-0042
Identifier Type: -
Identifier Source: org_study_id
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