Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents
Withdrawn before enrolling · Phase 3
Conditions studied: Anemia of Chronic Kidney Disease
In brief
This study will assess the safety and efficacy of once daily dosing of vadadustat for the treatment of pediatric participants with anemia of chronic kidney disease (CKD) naive to erythropoiesis-stimulating agent (ESA) treatment.
Key facts
- Study ID
- NCT05082584
- Run by
- Akebia Therapeutics
- People needed
- 0
- Starts
- 2025-01-01
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2025-10-01
Who can join
Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of anemia of chronic kidney disease (CKD)
- 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%
You may not qualify if…
- Anemia due to a cause other than CKD
- 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
Where it is running
- Research Site — Hackensack, New Jersey, United States
Full record on ClinicalTrials.gov
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