Renal AnemiaPhase 4NCT07537816
Effects of Vadadustat on Anemia, Quality of Life, and Inflammation in Dialysis Patients
A Phase 4 study testing Vadadustat in people with Renal Anemia, run by Mackay Memorial Hospital.
Trial summary
This is a two-period, two-sequence crossover study in patients receiving maintenance peritoneal dialysis. All participants remain on background darbepoetin alfa therapy throughout the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Anemia
- What is being tested?
- Vadadustat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 15 Oct 2026
- Phase
- Phase 4
- 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
- Age 18 years or older
- Receiving maintenance peritoneal dialysis
- Followed at the outpatient clinics of MacKay Memorial Hospital
- Receiving background darbepoetin alfa therapy
- Able and willing to provide informed consent
Who cannot join
- Blood pressure >170/80 mmHg on three separate occasions
- Recent cardiovascular events within the past 3 months, including coronary artery disease, myocardial ischemia, cerebrovascular disease, or peripheral artery disease
- Gastrointestinal bleeding within the past 3 months
- Active malignancy
About this study
Official title: A Prospective Interventional Study Evaluating the Effects of Vadadustat on Anemia, Quality of Life, and Inflammatory Response in Dialysis Patients and Exploring Predictors of Treatment Response
This is a two-period, two-sequence crossover study in patients receiving maintenance peritoneal dialysis. All participants remain on background darbepoetin alfa therapy throughout the study. The study compares add-on vadadustat plus background darbepoetin alfa with background darbepoetin alfa alone, with each treatment period lasting 8 weeks and separated by a 4-week washout period. Monthly laboratory assessments and dialysis adequacy measurements will be performed to evaluate anemia control, quality of life, inflammation, and dialysis adequacy.
- Conditions
- Renal Anemia
- Being tested
- Vadadustat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VadadustatDrug
Also called Darbepoetin alfa
Vadadustat administered orally for 8 weeks during the assigned treatment period. In this two-period crossover study, the two treatment periods are separated by a 4-week washout period.
| Study group | Role | What they receive |
|---|---|---|
| AB sequence: Vadadustat add-on followed by darbepoetin alfa alone | Other | Participants receive oral vadadustat in addition to background darbepoetin alfa during period 1 for 8 weeks, followed by background darbepoetin alfa alone during period 2 for 8 weeks. The two treatment periods are separated by a 4-week washout period. Receives: Drug: Vadadustat |
| BA sequence: Darbepoetin alfa alone followed by vadadustat add-on | Other | Participants receive background darbepoetin alfa alone during period 1 for 8 weeks, followed by oral vadadustat in addition to background darbepoetin alfa during period 2 for 8 weeks. The two treatment periods are separated by a 4-week washout period. Receives: Drug: Vadadustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin
Within-participant change in hemoglobin during add-on vadadustat treatment compared with background darbepoetin alfa alone in this two-period, two-sequence crossover study in patients receiving maintenance peritoneal dialysis.
Measured: Baseline and end of each 8-week treatment period (up to 5 months).
Secondary outcomes (9)
Change in SF-36 Physical Component Summary score
Change in health-related quality of life as assessed by the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) score during add-on vadadustat treatment compared with background darbepoetin alfa alone in this two-period, two-sequence crossover study in patients receiving maintenance peritoneal dialysis. Higher scores indicate better physical health status.
Measured: Baseline and end of each 8-week treatment period (up to 5 months).
Change in SF-36 Mental Component Summary score
Change in health-related quality of life as assessed by the 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) score during add-on vadadustat treatment compared with background darbepoetin alfa alone in this two-period, two-sequence crossover study in patients receiving maintenance peritoneal dialysis. Higher scores indicate better mental health status.
Measured: Baseline and end of each 8-week treatment period (up to 5 months).
Change in C-reactive protein
Change in serum C-reactive protein during add-on vadadustat treatment compared with background darbepoetin alfa alone.
Measured: Baseline and monthly during the study period, up to 5 months.
Change in erythrocyte sedimentation rate
Change in erythrocyte sedimentation rate during add-on vadadustat treatment compared with background darbepoetin alfa alone.
Measured: Baseline and monthly during the study period, up to 5 months.
Change in interleukin-6
Change in serum interleukin-6 during add-on vadadustat treatment compared with background darbepoetin alfa alone.
Measured: Baseline and monthly during the study period, up to 5 months.
Change in serum iron
Change in serum iron during add-on vadadustat treatment compared with background darbepoetin alfa alone.
Measured: Baseline and monthly during the study period, up to 5 months.
Change in total iron-binding capacity
Change in serum total iron-binding capacity during add-on vadadustat treatment compared with background darbepoetin alfa alone.
Measured: Baseline and monthly during the study period, up to 5 months.
Change in ferritin
Change in serum ferritin during add-on vadadustat treatment compared with background darbepoetin alfa alone.
Measured: Baseline and monthly during the study period, up to 5 months.
Change in transferrin saturation
Change in transferrin saturation during add-on vadadustat treatment compared with background darbepoetin alfa alone.
Measured: Baseline and monthly during the study period, up to 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal AnemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537816
- Sponsor's protocol ID
- 24MMHIS374e
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Interventional Study Evaluating the Effects of Vadadustat on Anemia, Quality of Life, and Inflammatory Response in Dialysis Patients and Exploring Predictors of Treatment Response
- ClinicalTrials.gov ID
- NCT07537816
- Acronym / sponsor ID
- 24MMHIS374e
- Conditions
- Renal Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 17 Apr 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.
This is a two-period, two-sequence crossover study in patients receiving maintenance peritoneal dialysis. All participants remain on background darbepoetin alfa therapy throughout the study. The study compares add-on vadadustat plus background darbepoetin alfa with background darbepoetin alfa alone, with each treatment period lasting 8 weeks and separated by a 4-week washout period. Monthly laboratory assessments and dialysis adequacy measurements will be performed to evaluate anemia control, quality of life, inflammation, and dialysis adequacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB sequence: Vadadustat add-on followed by darbepoetin alfa alone | Other | Drug: VadadustatParticipants receive oral vadadustat in addition to background darbepoetin alfa during period 1 for 8 weeks, followed by background darbepoetin alfa alone during period 2 for 8 weeks. The two treatment periods are separated by a 4-week washout period. |
| BA sequence: Darbepoetin alfa alone followed by vadadustat add-on | Other | Drug: VadadustatParticipants receive background darbepoetin alfa alone during period 1 for 8 weeks, followed by oral vadadustat in addition to background darbepoetin alfa during period 2 for 8 weeks. The two treatment periods are separated by a 4-week washout period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Receiving maintenance peritoneal dialysis
- Followed at the outpatient clinics of MacKay Memorial Hospital
- Receiving background darbepoetin alfa therapy
- Able and willing to provide informed consent
Key exclusion criteria (4 listed)
- Blood pressure >170/80 mmHg on three separate occasions
- Recent cardiovascular events within the past 3 months, including coronary artery disease, myocardial ischemia, cerebrovascular disease, or peripheral artery disease
- Gastrointestinal bleeding within the past 3 months
- Active malignancy
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: Darbepoetin alfaVadadustat administered orally for 8 weeks during the assigned treatment period. In this two-period crossover study, the two treatment periods are separated by a 4-week washout period. | Drug | AB sequence: Vadadustat add-on followed by darbepoetin alfa alone, BA sequence: Darbepoetin alfa alone followed by vadadustat add-on |
Primary outcome
Change in Hemoglobin
Time frame: Baseline and end of each 8-week treatment period (up to 5 months).
Within-participant change in hemoglobin during add-on vadadustat treatment compared with background darbepoetin alfa alone in this two-period, two-sequence crossover study in patients receiving maintenance peritoneal dialysis.
9 secondary outcomes
Change in SF-36 Physical Component Summary score
Time frame: Baseline and end of each 8-week treatment period (up to 5 months).
Change in SF-36 Mental Component Summary score
Time frame: Baseline and end of each 8-week treatment period (up to 5 months).
Change in C-reactive protein
Time frame: Baseline and monthly during the study period, up to 5 months.
Change in erythrocyte sedimentation rate
Time frame: Baseline and monthly during the study period, up to 5 months.
Change in interleukin-6
Time frame: Baseline and monthly during the study period, up to 5 months.
Change in serum iron
Time frame: Baseline and monthly during the study period, up to 5 months.
Change in total iron-binding capacity
Time frame: Baseline and monthly during the study period, up to 5 months.
Change in ferritin
Time frame: Baseline and monthly during the study period, up to 5 months.
Change in transferrin saturation
Time frame: Baseline and monthly during the study period, up to 5 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 23 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vadadustat in people with Renal Anemia, run by Mackay Memorial Hospital.
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 5 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: opening soon, as of the sponsor's last update on 23 Apr 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in Hemoglobin (time frame: Baseline and end of each 8-week treatment period (up to 5 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 23 Apr 2026.