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NCT05082584WithdrawnPhase 3

Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents

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 Naive to Erythropoiesis-stimulating Agents

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) naive to erythropoiesis-stimulating agent (ESA) treatment.

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Withdrawn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
NCT number
NCT05082584

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with an erythropoiesis-stimulating agents (ESA) within 8 weeks prior to Screening
  • 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 <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 screening hemoglobin (Hb) <10.0 grams/deciliters (g/dL)
  • Transferrin Saturation ≥ 20%

Age in the registry: 4 months to 16 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
-HackensackUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.