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

WITHDRAWNPHASE3

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

NCT05082584•Akebia Therapeutics

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

0 - 16 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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%

Exclusion Criteria

•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

Locations (1)

Research Site

Hackensack, New Jersey, United States

Key Dates

Start Date

January 1, 2025

Primary Completion Date

July 1, 2026

Completion Date

October 1, 2026

Last Updated

October 1, 2025

Conditions

Anemia of Chronic Kidney Disease

Interventions

Vadadustat

DRUG

A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).(Real World Evidence Study)

NCT05515367

Chronic Kidney DiseasesAnemia of Chronic Kidney Disease

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NOT_YET_RECRUITINGPHASE3

Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients

NCT06352138

Anemia of Chronic Kidney Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).(Real World Evidence Study)

Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients

Oral Liposomal Iron Versus Injectable Iron Sucrose for Anemia Treatment in Non-Dialysis Chronic Kidney Disease Patients

Effect of Adding Lactoferrin on Oral Iron on Anemia in Chronic Kidney Disease Patients

Desidustat in the Treatment of Chemotherapy Induced Anemia

Project Aura: Co-design of a Home-based Monitoring Service