Anemia of Chronic Kidney DiseasePhase 3VOICENCT06520826
Vafseo Outcomes In-Center Experience
A Phase 3 study testing Vadadustat and Erythropoiesis Stimulating Agent in people with Anemia of Chronic Kidney Disease, run by USRC Kidney Research at 5 sites in United States.
Trial summary
This trial is an investigator-initiated, multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the safety of vadadustat administered three times per week for the treatment of anemia in in-center hemodialysis patients 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?
- Vadadustat and Erythropoiesis Stimulating Agent
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Nov 2024to 30 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 patients greater than or equal to 18 years of age.
- Receiving outpatient in-center hemodialysis at least three times per week for end-stage kidney disease.
- Currently prescribed or eligible for erythropoiesis-stimulating agent based on approved facility policy
- Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
Who cannot join
- Contraindication to receive vadadustat or any of its known constituents per USPI.
- Cirrhosis or active, acute liver disease. Concomitant use of any hypoxia-inducible factor prolyl-hydroxylases or OAT1/OAT3 inhibitors (probenacid, rifampicin, gemfibrozil, or teriflunomide).
- Unable to comply with study requirements or in the opinion of a healthcare provider or a member of the central study team, not clinically stable to participate in the study.
- Pregnant at time of consent (per subject self-report).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dallas Renal Group
Dallas, Texas, 75230
Nephrology and Hypertension Specialists, PC
Dalton, Georgia, 30720
US Renal Care - Gallup
Gallup, New Mexico, 87301
US Renal Care - Live Oak
Live Oak, Texas, 78233
USRC Kidney Research
Lone Tree, Colorado, 80124
About this study
Official title: Safety of Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects: Vafseo Outcomes In-Center Experience
This trial is an investigator-initiated, multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the safety of vadadustat administered three times per week for the treatment of anemia in in-center hemodialysis patients with End Stage Kidney Disease (ESKD). This study will obtain long-term safety data in a large sample of subjects receiving in-center hemodialysis to support adoption of three times per week vadadustat dosing.
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- Vadadustat, Erythropoiesis Stimulating Agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VadadustatDrug
Also called Vafseo
A synthetic, orally bioavailable, small molecule being developed as an inhibitor of hypoxia-inducible factor prolyl-hydroxylases for the treatment of anemia associated with chronic kidney disease. Intervention to be administered to maintain hemoglobin within a target range of 10-11 g/dL.
Erythropoiesis Stimulating AgentDrug
Also called Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp)
Standard of care erythropoiesis stimulating agent will be administered to maintain hemoglobin within a target range of 10-11 g/dL.
| Study group | Role | What they receive |
|---|---|---|
| Vadadustat | Experimental | Vadadustat, 300 mg tablets, administered orally three times per week Receives: Drug: Vadadustat |
| Erythropoiesis-stimulating agent (ESA) - Standard of Care (SOC) | Active comparator | Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp) administered as per standard of care Receives: Drug: Erythropoiesis Stimulating Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combination of the hierarchical endpoints of all-cause mortality and all-cause hospitalization.
The hierarchical endpoints of all-cause mortality and all cause hospitalization will be analyzed by the win odds method with ranking all cause mortality more important than all cause hospitalization.
Measured: 18 months
Secondary outcomes (2)
All-cause hospitalization
All-cause hospitalization
Measured: 18 months
All-cause mortality
All-cause mortality
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start20 Nov 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
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
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- USRC Kidney Research
- Sponsor type
- Research network
- Collaborators
- Akebia Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520826
- Sponsor's protocol ID
- USRC-2024-001
- Acronym
- VOICE
- Status last verified
- Mar 2026
- First submitted
- 22 Jul 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects: Vafseo Outcomes In-Center Experience
- ClinicalTrials.gov ID
- NCT06520826
- Acronym / sponsor ID
- VOICE / USRC-2024-001
- Conditions
- Anemia of Chronic Kidney Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- USRC Kidney ResearchResearch network
- Collaborators
- Akebia Therapeutics
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 25 Jul 2024 (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 trial is an investigator-initiated, multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the safety of vadadustat administered three times per week for the treatment of anemia in in-center hemodialysis patients with End Stage Kidney Disease (ESKD). This study will obtain long-term safety data in a large sample of subjects receiving in-center hemodialysis to support adoption of three times per week vadadustat dosing.
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: VadadustatVadadustat, 300 mg tablets, administered orally three times per week |
| Erythropoiesis-stimulating agent (ESA) - Standard of Care (SOC) | Active comparator | Drug: Erythropoiesis Stimulating AgentEpoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp) administered as per standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients greater than or equal to 18 years of age.
- Receiving outpatient in-center hemodialysis at least three times per week for end-stage kidney disease.
- Currently prescribed or eligible for erythropoiesis-stimulating agent based on approved facility policy
- Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
Key exclusion criteria (4 listed)
- Contraindication to receive vadadustat or any of its known constituents per USPI.
- Cirrhosis or active, acute liver disease. Concomitant use of any hypoxia-inducible factor prolyl-hydroxylases or OAT1/OAT3 inhibitors (probenacid, rifampicin, gemfibrozil, or teriflunomide).
- Unable to comply with study requirements or in the opinion of a healthcare provider or a member of the central study team, not clinically stable to participate in the study.
- Pregnant at time of consent (per subject 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 |
|---|---|---|
| VadadustatAlso: VafseoA synthetic, orally bioavailable, small molecule being developed as an inhibitor of hypoxia-inducible factor prolyl-hydroxylases for the treatment of anemia associated with chronic kidney disease. Intervention to be administered to maintain hemoglobin within a target range of 10-11 g/dL. | Drug | Vadadustat |
| Erythropoiesis Stimulating AgentAlso: Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp)Standard of care erythropoiesis stimulating agent will be administered to maintain hemoglobin within a target range of 10-11 g/dL. | Drug | Erythropoiesis-stimulating agent (ESA) - Standard of Care (SOC) |
Primary outcome
Combination of the hierarchical endpoints of all-cause mortality and all-cause hospitalization.
Time frame: 18 months
The hierarchical endpoints of all-cause mortality and all cause hospitalization will be analyzed by the win odds method with ranking all cause mortality more important than all cause hospitalization.
2 secondary outcomes
All-cause hospitalization
Time frame: 18 months
All-cause mortality
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
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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.
5 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 Vadadustat and Erythropoiesis Stimulating Agent in people with Anemia of Chronic Kidney Disease, run by USRC Kidney Research at 5 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
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?
Combination of the hierarchical endpoints of all-cause mortality and all-cause hospitalization. (time frame: 18 months). 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 10 Mar 2026.