A Phase 3 interventional study of vadadustat in Anemia of Chronic Kidney Disease, sponsored by Akebia Therapeutics. Withdrawn at 1 site in United States. Open to participants aged 4 Months to 16 Years. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Akebia Therapeutics · Phase 3, Interventional, and Treatment
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).
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
Browse Anemia studies →Akebia Therapeutics is the lead sponsor of 34 studies on the registry; 3 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 12 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: vadadustat
Vadadustat tablet orally once a day for 52 weeks
Also known as: AKB-6548
Mean Change in Hemoglobin (Hb) Values Between Baseline and the Primary Evaluation Period (Average Hb From Weeks 21 to 28)
Time frame: Baseline; Weeks 21 to 28
Time to Achieve Hb Levels of ≥10.0 grams/deciliters (g/dL)
Time frame: Up to Week 52
Number of Participants With Mean Hb Values Within the Target Range During the Primary Evaluation Period
Time frame: From Week 21 to Week 28
Number of Participants With Mean Hb Values Within the Target Range During the Extension Period
Time frame: From Week 29 to Week 52
Number of Participants With Treatment-emergent Adverse Events and who Discontinued From the Study due to Adverse Events
Time frame: Up to Week 56
Maximum Observed Plasma Concentration (Cmax) of Vadadustat and its Metabolites
Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks
Time to Reach Cmax (Tmax) of Vadadustat and its Metabolites
Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks
Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC 0-t) of Vadadustat and its Metabolites
Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks
Terminal Elimination Half-Life (t1/2) of Vadadustat and its Metabolites
Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks
Change From Baseline in Serum Erythropoietin (EPO)
Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks
Change From Baseline in Reticulocyte Count
Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks
Change From Baseline in Hb levels
Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Akebia Therapeutics