Anemia of Chronic Kidney DiseasePhase 3CONVERSIONNCT05082571
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease
A Phase 3 study testing vadadustat in people with Anemia of Chronic Kidney Disease, run by Akebia Therapeutics at 1 site in United States.
Trial summary
This study will assess the safety and efficacy of once daily dosing of vadadustat for the treatment of pediatric participants with anemia of Chronic Kidney Disease (CKD) after conversion from an Erythropoiesis Stimulating Agent (ESA). Read more about this study
- Who is it for?
- Ages 4 months to 16 years
- Conditions the study is for
- Anemia of Chronic Kidney Disease
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2025to Oct 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 4 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of anemia of chronic kidney disease (CKD)
- Diagnosis of non-dialysis-dependent (NDD) CKD with an estimated glomerular filtration rate of greater than (>) 10 and less than (<) 60 milliliters/minute/1.73 meters^2 (mL/min/1.73 m^2) or diagnosis of dialysis dependent (DD) CKD
- Mean hemoglobin (Hb) between 9.0 and 12.0 grams/deciliters (g/dL) (inclusive)
- Transferrin Saturation ≥ 20%
Who cannot join
- Anemia due to a cause other than CKD
- Active bleeding or recent clinically significant blood loss
- History of sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
- Red Blood Cells transfusion within 4 weeks
- Serum albumin level less than 2.5 g/dL
- Uncontrolled hypertension
Show all 9Show fewer
- Active malignancy or treatment for malignancy within the past 2 years prior to Screening
- Evidence of iron overload or diagnosis of hemochromatosis
- Known hypersensitivity to vadadustat or any excipients in vadadustat tablet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Once Daily Oral Vadadustat for the Treatment of Pediatric Subjects With Anemia of Chronic Kidney Disease After Conversion From an Erythropoiesis-stimulating Agent
This study will assess the safety and efficacy of once daily dosing of vadadustat for the treatment of pediatric participants with anemia of Chronic Kidney Disease (CKD) after conversion from an Erythropoiesis Stimulating Agent (ESA).
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- vadadustat
- Keywords
- anemia, kidney disease, vadadustat, pediatric population, children, chronic kidney disease, erythropoiesis stimulating agent, dialysis, hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor
- Medical subject headings
- Anemia, Kidney Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vadadustatDrug
Also called AKB-6548
Vadadustat tablet orally once a day for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vadadustat | Experimental | Cohort 1: participants with ≥12 years to <17 years; Cohort 2: participants with ≥6 years to <12 years; Cohort 3(a): participants with ≥2 years to <6 years; and Cohort 3(b): participants with ≥4 months to <2 years Receives: Drug: vadadustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Hemoglobin (Hb) Values Between Baseline and the Primary Evaluation Period (Average Hb From Weeks 21 to 28)
Measured: Baseline; Weeks 21 to 28
Secondary outcomes (11)
Time to Achieve Hb Levels of ≥10.0 grams/deciliters (g/dL)
Measured: Up to Week 52
Number of Participants With Mean Hb Values Within the Target Range During the Primary Evaluation Period
Measured: From Week 21 to Week 28
Number of Participants With Mean Hb Values Within the Target Range During the Extension Period
Measured: From Week 29 to Week 52
Number of Participants With Treatment-emergent Adverse Events and who Discontinued From the Study due to Adverse Events
Measured: Up to Week 56
Maximum Observed Plasma Concentration (Cmax) of Vadadustat and its Metabolites
Measured: Pre-dose and post-dose at intermediate time points up to 28 weeks
Time to Reach Cmax (Tmax) of Vadadustat and its Metabolites
Measured: Pre-dose and post-dose at intermediate time points up to 28 weeks
Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC 0-t) of Vadadustat and its Metabolites
Measured: Pre-dose and post-dose at intermediate time points up to 28 weeks
Terminal Elimination Half-Life (t1/2) of Vadadustat and its Metabolites
Measured: Pre-dose and post-dose at intermediate time points up to 28 weeks
Change From Baseline in Serum Erythropoietin (EPO)
Measured: Pre-dose and post-dose at intermediate time points up to 28 weeks
Change From Baseline in Reticulocyte Count
Measured: Pre-dose and post-dose at intermediate time points up to 28 weeks
Change From Baseline in Hb levels
Measured: Pre-dose and post-dose at intermediate time points up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study startJan 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Why it stopped: Sponsor decision
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akebia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Akebia Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082571
- Sponsor's protocol ID
- AKB-6548-CI-0041
- Acronym
- CONVERSION
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2021
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Once Daily Oral Vadadustat for the Treatment of Pediatric Subjects With Anemia of Chronic Kidney Disease After Conversion From an Erythropoiesis-stimulating Agent
- ClinicalTrials.gov ID
- NCT05082571
- Acronym / sponsor ID
- CONVERSION / AKB-6548-CI-0041
- Conditions
- Anemia of Chronic Kidney Disease
- Keywords
- anemia, kidney disease, vadadustat, pediatric population, children, chronic kidney disease, erythropoiesis stimulating agent, dialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Akebia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 19 Oct 2021 (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 study will assess the safety and efficacy of once daily dosing of vadadustat for the treatment of pediatric participants with anemia of Chronic Kidney Disease (CKD) after conversion from an Erythropoiesis Stimulating Agent (ESA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vadadustat | Experimental | Drug: vadadustatCohort 1: participants with ≥12 years to <17 years; Cohort 2: participants with ≥6 years to <12 years; Cohort 3(a): participants with ≥2 years to <6 years; and Cohort 3(b): participants with ≥4 months to <2 years |
Who may qualify
- Ages
- 4 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of anemia of chronic kidney disease (CKD)
- Diagnosis of non-dialysis-dependent (NDD) CKD with an estimated glomerular filtration rate of greater than (>) 10 and less than (<) 60 milliliters/minute/1.73 meters^2 (mL/min/1.73 m^2) or diagnosis of dialysis dependent (DD) CKD
- Mean hemoglobin (Hb) between 9.0 and 12.0 grams/deciliters (g/dL) (inclusive)
- Transferrin Saturation ≥ 20%
Key exclusion criteria (9 listed)
- Anemia due to a cause other than CKD
- Active bleeding or recent clinically significant blood loss
- History of sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
- Red Blood Cells transfusion within 4 weeks
- Serum albumin level less than 2.5 g/dL
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: AKB-6548Vadadustat tablet orally once a day for 52 weeks | Drug | Vadadustat |
Primary outcome
Mean Change in Hemoglobin (Hb) Values Between Baseline and the Primary Evaluation Period (Average Hb From Weeks 21 to 28)
Time frame: Baseline; Weeks 21 to 28
11 secondary outcomes
Time to Achieve Hb Levels of ≥10.0 grams/deciliters (g/dL)
Time frame: Up to Week 52
Number of Participants With Mean Hb Values Within the Target Range During the Primary Evaluation Period
Time frame: From Week 21 to Week 28
Number of Participants With Mean Hb Values Within the Target Range During the Extension Period
Time frame: From Week 29 to Week 52
Number of Participants With Treatment-emergent Adverse Events and who Discontinued From the Study due to Adverse Events
Time frame: Up to Week 56
Maximum Observed Plasma Concentration (Cmax) of Vadadustat and its Metabolites
Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks
Time to Reach Cmax (Tmax) of Vadadustat and its Metabolites
Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks
Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC 0-t) of Vadadustat and its Metabolites
Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks
Terminal Elimination Half-Life (t1/2) of Vadadustat and its Metabolites
Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks
Change From Baseline in Serum Erythropoietin (EPO)
Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks
Change From Baseline in Reticulocyte Count
Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks
Change From Baseline in Hb levels
Time frame: Pre-dose and post-dose at intermediate time points up to 28 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- 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.
Chief Medical Officer study director
Akebia Therapeutics
1 site 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 in people with Anemia of Chronic Kidney Disease, run by Akebia Therapeutics at 1 site 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 9 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: withdrawn, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Mean Change in Hemoglobin (Hb) Values Between Baseline and the Primary Evaluation Period (Average Hb From Weeks 21 to 28) (time frame: Baseline; Weeks 21 to 28). 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 1 Oct 2025.