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CompletedNCT06901505Updated Sep 4, 2026

To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis

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

Phase
Phase 3
Study type
Interventional
Enrollment
353
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Anemia of Chronic Kidney Disease

Keywords

  • Chronic Kidney Disease
  • Hemodialysis
  • Erythropoiesis-Stimulating Agent
  • Open-label
  • Vadadustat
03

In context

Renal Insufficiency, Chronic

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult participants ≥18 years of age.
  • Receiving outpatient in-center hemodialysis for ESKD at least three times a week.
  • Currently prescribed or meets criteria for ESA based on approved facility policy.
  • Hb > 8 grams per deciliter (g/dl).
  • Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20%.
  • Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
  • For selected sites, individuals who opt to participate in the RBC sub-study must meet the following inclusion criteria:
  • Currently prescribed or will be prescribed methoxy polyethylene glycol-epoetin beta.
  • Hb \<11.5 g/dL

Exclusion criteria

Exclusion Criteria:

  • Contraindication to receive vadadustat per United States prescribing information (USPI) as determined by the treating health care provider.
  • Concomitant use of any hypoxia-inducible factor prolyl hydroxylase inhibitor(HIF-PHI).
  • Known cirrhosis or active, acute liver disease.
  • Unable to comply with study requirements or compliance with attending dialysis treatments as prescribed, or in the opinion of the treating physician or Investigator, not clinically stable to participate in the study.
  • Pregnant at the time of consent (per participant self-report).
  • Any other reason, which in the opinion of the Investigator, would make the participants unsuitable for participation in the study.
  • For selected sites, individuals who opt to participate in the RBC sub-study must also not meet the following exclusion criteria:
  • History of, or currently diagnosed with, any hematological disease, such as sickle cell disease, thalassemia, hemochromatosis, Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency, myelodysplastic syndromes, or any other blood disorder that could interfere with the study outcomes.
  • Participants will receive a blood transfusion within 3 months prior to the initiation of the study.
  • History of or currently diagnosed with chronic lung disease
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
353 participants (actual)

Study arms

  • Experimental
    Vadadustat

    Study drug will be administered three times a week.

    Drug: Vadadustat

  • Active comparator
    Erythropoiesis-Stimulating Agent (ESA)

    Dose adjustments will be determined by hemoglobin (Hb) change and current dose of ESA, per ESA dosing protocol

    Drug: Erythropoiesis-Stimulating Agent (ESA)

Interventions

  • DrugErythropoiesis-Stimulating Agent (ESA)

    Administered by intra-venous (IV) infusion.

  • DrugVadadustat

    300mg, oral tablets

    Also known as: Vafseo, AKB-6548

06

What researchers measure

Primary outcomes

  1. Change in hemoglobin (Hb)

    Time frame: Baseline and the mean of Week 20 to 24

Secondary outcomes

  1. Number of participants reporting treatment-emergent serious adverse events (TESAEs)

    Time frame: Up to 29 Weeks

  2. Proportion of participants with mean Hb levels within target range

    Time frame: Week 16 to Week 24

  3. Proportion of participants receiving RBC transfusions

    Time frame: Up to 29 Weeks

07

Study locations

18 sites
  • DaVita Research Site
    Montgomery, Alabama 36117-7306, United States
  • DaVita Research Site
    Hartford, Connecticut 06112-1260, United States
  • DaVita Research Site
    Middlebury, Connecticut 06705-3893, United States
  • DaVita Research Site
    Columbus, Georgia 31904-3604, United States
  • DaVita Research Site #1
    Minneapolis, Minnesota 55435-1807, United States
  • DaVita Research Site
    Minneapolis, Minnesota 55435-1807, United States
  • DaVita Research Site
    Henderson, Nevada 89052-5548, United States
  • DaVita Research Site
    Las Vegas, Nevada 89128-0804, United States
  • DaVita Research Site #1
    El Paso, Texas 79835-2200, United States
  • DaVita Research Site
    El Paso, Texas 79835-2200, United States
  • DaVita Research Site #1
    Houston, Texas 77054-3836, United States
  • DaVita Research Site
    Houston, Texas 77054-3836, United States
  • DaVita Research Site #1
    San Antonio, Texas 78258-4800, United States
  • DaVita Research Site #2
    San Antonio, Texas 78258-4800, United States
  • DaVita Research Site
    San Antonio, Texas 78258-4800, United States
  • DaVita Research Site
    The Woodlands, Texas 77384-3024, United States
  • DaVita Research Site #1
    Norfolk, Virginia 23502-3235, United States
  • DaVita Research Site
    Norfolk, Virginia 23502-3235, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06901505
Lead sponsor
Akebia Therapeutics
Responsible party
Sponsor
First posted
Mar 30, 2025
Start date
Jul 24, 2025
Primary completion
Aug 12, 2026
Completion
Aug 12, 2026
Last update
Sep 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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