NCT05082571WithdrawnPhase 3
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease
A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Once Daily Oral Vadadustat for the Treatment of Pediatric Subjects With Anemia of Chronic Kidney Disease After Conversion From an Erythropoiesis-stimulating Agent
Source: ClinicalTrials.gov · Last updated 1 Oct 2025
Reason given: Sponsor decision
Brief summary (registry, in English)
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) after conversion from an Erythropoiesis Stimulating Agent (ESA).
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 28 Sept 2021
- Start date
- Jan 2025
- Primary completion date
- Jul 2026
- Lead sponsor
- Akebia Therapeutics
- Diseases
- Chronic kidney disease
- NCT number
- NCT05082571
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active malignancy or treatment for malignancy within the past 2 years prior to Screening
Other illness
- Active bleeding or recent clinically significant blood loss
- History of sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
- Uncontrolled hypertension
- Known hypersensitivity to vadadustat or any excipients in vadadustat tablet
Lab values
- Serum albumin level less than 2.5 g/dL
Other
- Anemia due to a cause other than CKD
- Red Blood Cells transfusion within 4 weeks
- Evidence of iron overload or diagnosis of hemochromatosis
Who the study is looking for
- 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 hemoglobin (Hb) between 9.0 and 12.0 grams/deciliters (g/dL) (inclusive)
- Transferrin Saturation ≥ 20%
Age in the registry: 4 months to 16 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - | Hackensack | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.