Anemia of Chronic Kidney DiseasePhase 3NCT06901505
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 study testing Erythropoiesis-Stimulating Agent (ESA) and Vadadustat in people with Anemia of Chronic Kidney Disease, run by Akebia Therapeutics at 18 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia of Chronic Kidney Disease
- What is being tested?
- Erythropoiesis-Stimulating Agent (ESA) and Vadadustat
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 18 sitesUnited States
- Study dates
- 24 Jul 2025to 12 Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
DaVita Research Site
Columbus, Georgia, 31904-3604
DaVita Research Site #1
El Paso, Texas, 79835-2200
DaVita Research Site
El Paso, Texas, 79835-2200
DaVita Research Site
Hartford, Connecticut, 06112-1260
DaVita Research Site
Henderson, Nevada, 89052-5548
DaVita Research Site #1
Houston, Texas, 77054-3836
DaVita Research Site
Houston, Texas, 77054-3836
DaVita Research Site
Las Vegas, Nevada, 89128-0804
DaVita Research Site
Middlebury, Connecticut, 06705-3893
DaVita Research Site #1
Minneapolis, Minnesota, 55435-1807
DaVita Research Site
Minneapolis, Minnesota, 55435-1807
DaVita Research Site
Montgomery, Alabama, 36117-7306
DaVita Research Site #1
Norfolk, Virginia, 23502-3235
DaVita Research Site
Norfolk, Virginia, 23502-3235
DaVita Research Site #1
San Antonio, Texas, 78258-4800
DaVita Research Site #2
San Antonio, Texas, 78258-4800
DaVita Research Site
San Antonio, Texas, 78258-4800
DaVita Research Site
The Woodlands, Texas, 77384-3024
About this study
Official title: A Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy of Three Times Weekly Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis
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.
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- Erythropoiesis-Stimulating Agent (ESA), Vadadustat
- Keywords
- Chronic Kidney Disease, Hemodialysis, Erythropoiesis-Stimulating Agent, Open-label, Vadadustat
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythropoiesis-Stimulating Agent (ESA)Drug
Administered by intra-venous (IV) infusion.
VadadustatDrug
Also called Vafseo, AKB-6548
300mg, oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Vadadustat | Experimental | Study drug will be administered three times a week. Receives: Drug: Vadadustat |
| Erythropoiesis-Stimulating Agent (ESA) | Active comparator | Dose adjustments will be determined by hemoglobin (Hb) change and current dose of ESA, per ESA dosing protocol Receives: Drug: Erythropoiesis-Stimulating Agent (ESA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin (Hb)
Measured: Baseline and the mean of Week 20 to 24
Secondary outcomes (3)
Number of participants reporting treatment-emergent serious adverse events (TESAEs)
Measured: Up to 29 Weeks
Proportion of participants with mean Hb levels within target range
Measured: Week 16 to Week 24
Proportion of participants receiving RBC transfusions
Measured: Up to 29 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start24 Jul 2025
- Primary completion12 Aug 2026
- Study completion12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akebia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901505
- Sponsor's protocol ID
- AKB-6548-CI-0052
- Other IDs
- VOCAL
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy of Three Times Weekly Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis
- ClinicalTrials.gov ID
- NCT06901505
- Acronym / sponsor ID
- AKB-6548-CI-0052
- Conditions
- Anemia of Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Hemodialysis, Erythropoiesis-Stimulating Agent, Open-label, Vadadustat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Akebia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vadadustat | Experimental | Drug: VadadustatStudy drug will be administered three times a week. |
| Erythropoiesis-Stimulating Agent (ESA) | Active comparator | Drug: Erythropoiesis-Stimulating Agent (ESA)Dose adjustments will be determined by hemoglobin (Hb) change and current dose of ESA, per ESA dosing protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erythropoiesis-Stimulating Agent (ESA)Administered by intra-venous (IV) infusion. | Drug | Erythropoiesis-Stimulating Agent (ESA) |
| VadadustatAlso: Vafseo, AKB-6548300mg, oral tablets | Drug | Vadadustat |
Primary outcome
Change in hemoglobin (Hb)
Time frame: Baseline and the mean of Week 20 to 24
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erythropoiesis-Stimulating Agent (ESA) and Vadadustat in people with Anemia of Chronic Kidney Disease, run by Akebia Therapeutics at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin (Hb) (time frame: Baseline and the mean of Week 20 to 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.