Anemia Associated With Chronic Kidney DiseasePhase 3VOTENCT07565701
Safety and Efficacy of a Phased Transition From Epogen to Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Subjects Receiving In-Center Hemodialysis
A Phase 3 study testing Epoetin alga (Epogen)/vadadustat in people with Anemia Associated With Chronic Kidney Disease, run by Geoff Block.
Trial summary
The goal of this study is to assess if patients can be retained on long-term vadadustat therapy (and thus potentially benefit from the favorable safety profile) by incorporating a phased transition from Epogen to three times per week vadadustat (TIW-V), reducing the likelihood of GI intolerance through use of a lower… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia Associated With Chronic Kidney Disease
- What is being tested?
- Epoetin alga (Epogen)/vadadustat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Jun 2027
- 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 ≥18 years of age
- Receiving outpatient in-center hemodialysis for ESKD at least TIW (prescribed)
- Currently receiving EPO (active administration, not on HOLD)
- Less than or equal to 0.75 g/d difference between last 2 Hgb values prior to Screening, with neither Hgb <9 g/dL
- Average of last 2 Hgb between 9-11.4 g/dL (inclusive) prior to Screening
- Central Screening Hgb 9-11.4 g/dL (inclusive)
Show all 9Show fewer
- Central Screening transferrin saturation greater than or equal to 20%
- Central Screening serum ferritin greater than or equal to 100 ng/mL
- 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 per United States Prescribing Information (USPI) including Screening liver function tests greater than 3x the upper limit of normal (ULN)
- Electronic Medical Record (EMR)-documented history of cirrhosis or active, acute liver disease
- EMR-documented history of currently active malignancy excluding non-melanomatous skin cancer and in-situ cervical cancer
- Concomitant use of HIF-PHI or OAT1/OAT3 inhibitors (probenecid, rifampicin, gemfibrozil, or teriflunomide)
- Unable to comply with study requirements or in the opinion of a healthcare provider or member of the central study team, not clinically stable to participate in the study
- Documented unplanned absence from dialysis greater than or equal to 3 times in 30 days prior to Screening (excluding rescheduled dialysis treatments)
- Pregnant at time of consent (per subject self-report)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Martha Block contact
About this study
The goal of this study is to assess if patients can be retained on long-term vadadustat therapy (and thus potentially benefit from the favorable safety profile) by incorporating a phased transition from Epogen to three times per week vadadustat (TIW-V), reducing the likelihood of GI intolerance through use of a lower vadadustat starting dose, and also reducing or eliminating the initial reduction in hemoglobin through the maintenance of low dose Epogen until target hemoglobin stability is achieved on a tolerable dose of TIW-V.
Read the detailed description
This is a multi-center, single-arm, open-label study assessing the safety of a phased transition from Epogen to three times per week vadadustat (TIW-V) for the treatment of anemia in subjects receiving in-center hemodialysis.
Subjects who have signed an IRB-approved informed consent form and who meet all of the inclusion criteria and none of the exclusion criteria will simultaneously have their Epogen dose reduced by 50% and initiate 300 mg vadadustat TIW.
Subsequent dose modifications will occur in order to target a narrow hemoglobin range (10-11 g/dL). Patients will have their hemoglobin assessed every 2 weeks and will continue in the trial for up to 28 weeks.
- Being tested
- Epoetin alga (Epogen)/vadadustat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin alga (Epogen)/vadadustatDrug
Phased transition from Epogen to three times weekly (TIW) oral vadadustat
| Study group | Role | What they receive |
|---|---|---|
| Phased transition from Epogen to three times weekly (TIW) oral vadadustat | Experimental | Not described Receives: Drug: Epoetin alga (Epogen)/vadadustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients starting three times per week vadadustat (TIW-V) who remain on TIW-V at week 20
Measured: 20 weeks
Secondary outcomes (2)
Proportion of patients starting three times per week vadadustat (TIW-V) who do not demonstrate a drop in Hgb >0.75 g/dL at any point from baseline to week 20
Measured: 20 weeks
Proportion of patients starting three times per week vadadustat (TIW-V) who achieve a mean Hgb in a range of 9-11.5 g/dL during weeks 20-24
Measured: weeks 20-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia Associated With 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geoff Block
- Sponsor type
- Research network
- Collaborators
- Akebia Therapeutics
- Responsible party
- Sponsor-investigator, Geoff Block, USRC Kidney Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565701
- Sponsor's protocol ID
- USRC-2026-001
- Acronym
- VOTE
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 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 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Phased Transition From Epogen to Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Subjects Receiving In-Center Hemodialysis
- ClinicalTrials.gov ID
- NCT07565701
- Acronym / sponsor ID
- VOTE / USRC-2026-001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Geoff BlockResearch network
- Collaborators
- Akebia Therapeutics
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 May 2026 (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.
The goal of this study is to assess if patients can be retained on long-term vadadustat therapy (and thus potentially benefit from the favorable safety profile) by incorporating a phased transition from Epogen to three times per week vadadustat (TIW-V), reducing the likelihood of GI intolerance through use of a lower vadadustat starting dose, and also reducing or eliminating the initial reduction in hemoglobin through the maintenance of low dose Epogen until target hemoglobin stability is achieved on a tolerable dose of TIW-V.
Detailed description
This is a multi-center, single-arm, open-label study assessing the safety of a phased transition from Epogen to three times per week vadadustat (TIW-V) for the treatment of anemia in subjects receiving in-center hemodialysis.
Subjects who have signed an IRB-approved informed consent form and who meet all of the inclusion criteria and none of the exclusion criteria will simultaneously have their Epogen dose reduced by 50% and initiate 300 mg vadadustat TIW.
Subsequent dose modifications will occur in order to target a narrow hemoglobin range (10-11 g/dL). Patients will have their hemoglobin assessed every 2 weeks and will continue in the trial for up to 28 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phased transition from Epogen to three times weekly (TIW) oral vadadustat | Experimental | Drug: Epoetin alga (Epogen)/vadadustat |
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 patients ≥18 years of age
- Receiving outpatient in-center hemodialysis for ESKD at least TIW (prescribed)
- Currently receiving EPO (active administration, not on HOLD)
- Less than or equal to 0.75 g/d difference between last 2 Hgb values prior to Screening, with neither Hgb <9 g/dL
- Average of last 2 Hgb between 9-11.4 g/dL (inclusive) prior to Screening
Key exclusion criteria (7 listed)
- Contraindication to receive vadadustat per United States Prescribing Information (USPI) including Screening liver function tests greater than 3x the upper limit of normal (ULN)
- Electronic Medical Record (EMR)-documented history of cirrhosis or active, acute liver disease
- EMR-documented history of currently active malignancy excluding non-melanomatous skin cancer and in-situ cervical cancer
- Concomitant use of HIF-PHI or OAT1/OAT3 inhibitors (probenecid, rifampicin, gemfibrozil, or teriflunomide)
- Unable to comply with study requirements or in the opinion of a healthcare provider or member of the central study team, not clinically stable to participate in the study
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 |
|---|---|---|
| Epoetin alga (Epogen)/vadadustatPhased transition from Epogen to three times weekly (TIW) oral vadadustat | Drug | Phased transition from Epogen to three times weekly (TIW) oral vadadustat |
Primary outcome
Proportion of patients starting three times per week vadadustat (TIW-V) who remain on TIW-V at week 20
Time frame: 20 weeks
2 secondary outcomes
Proportion of patients starting three times per week vadadustat (TIW-V) who do not demonstrate a drop in Hgb >0.75 g/dL at any point from baseline to week 20
Time frame: 20 weeks
Proportion of patients starting three times per week vadadustat (TIW-V) who achieve a mean Hgb in a range of 9-11.5 g/dL during weeks 20-24
Time frame: weeks 20-24
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 4 May 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.
Martha Block contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epoetin alga (Epogen)/vadadustat in people with Anemia Associated With Chronic Kidney Disease, run by Geoff Block.
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 7 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: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Stephanie Brillhart (13038819451, stephanie.brillhart@usrenalcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients starting three times per week vadadustat (TIW-V) who remain on TIW-V at week 20 (time frame: 20 weeks). 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 May 2026.