A Phase 3 interventional study of Erythropoiesis-Stimulating Agent (ESA) and Vadadustat in Anemia of Chronic Kidney Disease, sponsored by Akebia Therapeutics. Completed at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Akebia Therapeutics · Phase 3, Interventional, and Treatment
This is a multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the efficacy of vadadustat administered three times a week compared to standard of care erythropoiesis-stimulating agent for the treatment of anemia in in-center hemodialysis participants with end-stage kidney disease (ESKD). A subset of sites will participate in a red blood cell (RBC) sub-study where changes in the phenotype of RBCs in response to vadadustat treatment relative to methoxy polyethylene glycol-epoetin beta treatment in DD-CKD participants with anemia will be assessed. A separate informed consent form (ICF) will be signed by these participants who opt to be in the RBC sub-study. Of the 350 participants in the main study, approximately 28 participants will also be enrolled into the RBC sub-study. The total duration of the study is approximately 35 Weeks including screening and follow-up.
3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.
This study's enrollment of 353 is above the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic 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.
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Exclusion Criteria:
Study drug will be administered three times a week.
Drug: Vadadustat
Dose adjustments will be determined by hemoglobin (Hb) change and current dose of ESA, per ESA dosing protocol
Drug: Erythropoiesis-Stimulating Agent (ESA)
Administered by intra-venous (IV) infusion.
300mg, oral tablets
Also known as: Vafseo, AKB-6548
Change in hemoglobin (Hb)
Time frame: Baseline and the mean of Week 20 to 24
Number of participants reporting treatment-emergent serious adverse events (TESAEs)
Time frame: Up to 29 Weeks
Proportion of participants with mean Hb levels within target range
Time frame: Week 16 to Week 24
Proportion of participants receiving RBC transfusions
Time frame: Up to 29 Weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Akebia Therapeutics