Anemia Associated With Chronic Kidney Disease (CKD)Phase 3NCT04707768
Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
A Phase 3 study testing Vadadustat and Mircera® in people with Anemia Associated With Chronic Kidney Disease (CKD), run by Akebia Therapeutics at 58 sites in United States.
Trial summary
This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of anemia in hemodialysis participants. 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 (CKD)
- What is being tested?
- Vadadustat and Mircera®
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 58 sitesUnited States
- Study dates
- 18 Jun 2021to 30 Jan 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- ≥18 years of age
- Receiving chronic, outpatient in-center hemodialysis three times weekly (TIW) for end-stage kidney disease for at least 12 weeks prior to Screening Visit 1 (SV1)
- Currently maintained on Mircera® (≤250 μg/month) with at least 2 doses received within 8 weeks prior to Screening Visit 2 (SV2)
- Mean Screening hemoglobin (Hb) between 8.5 and 11.0 grams per deciliter (g/dL) (inclusive), as determined by the average of 2 Hb values measured by the central laboratory at least 4 days apart between SV1 and SV2
- Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening
- Folate and vitamin B12 measurements ≥ lower limit of normal during Screening
Who cannot join
- Anemia due to a cause other than chronic kidney disease (CKD).
- Clinically meaningful bleeding event within 8 weeks prior to Baseline
- Red blood cell (RBC) transfusion within 8 weeks prior to Baseline
- Having received any doses of darbepoetin alfa (Aranesp®) within 4 weeks prior to Baseline
- Having received any doses of epoetin alfa (Epogen®) within 1 week prior to Baseline.
- Current uncontrolled hypertension.
- Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure (HF) or New York Heart Association Class IV HF, or stroke within 12 weeks prior to or during Screening.
- Known hypersensitivity to vadadustat, Mircera®, or any of their excipients.
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
United States58 sites
Research Site
Albuquerque, New Mexico, 87109
Research Site
Alexandria, Virginia, 22304
Research Site
Arlington, Texas, 76015
Research Site
Arvada, Colorado, 80002
Research Site
Athens, Georgia, 30606
Research Site
Austin, Texas, 78758
Research Site
Baton Rouge, Louisiana, 70884
Research Site
Bradenton, Florida, 34209
Research Site
Brookhaven, Mississippi, 39601
Research Site
Buford, Georgia, 30518
Research Site
Charlotte, North Carolina, 28204
Research Site
Columbus, Mississippi, 39705
Research Site
Columbus, Ohio, 43215
Research Site
Coral Gables, Florida, 33134
Research Site#1
Coral Springs, Florida, 33071
Research Site#2
Coral Springs, Florida, 33071
Research Site
Dallas, Texas, 75230
Research Site
Dallas, Texas, 75231
Research Site
Dalton, Georgia, 30720
Research Site
Denver, Colorado, 80210
Research Site
Durham, North Carolina, 27704
Research Site
El Centro, California, 92243
Research Site
Escondido, California, 92025
Research Site
Fresno, California, 93720
Research Site
Gallup, New Mexico, 87301
Research Site
Granada Hills, California, 91344
Research Site
Hockessin, Delaware, 19707
Research Site
Houston, Texas, 77074
Research Site
Houston, Texas, 77099
Research Site
Huntsville, Alabama, 35805
Research Site
Jacksonville, Florida, 32216
Research Site
Kalamazoo, Michigan, 49007
Research Site
Kinston, North Carolina, 28504
Research Site
Kittanning, Pennsylvania, 16201
Research Site
Knoxville, Tennessee, 37923
Research Site
Las Vegas, Nevada, 89115
Research Site
Macon, Georgia, 31201
Research Site
Mansfield, Texas, 76063
Research Site
Mission, Texas, 78572
Research Site
Nampa, Idaho, 83687
Research Site
North Platte, Nebraska, 69101
Research Site
Phoenix, Arizona, 85035
Research Site
Pine Bluff, Arkansas, 71603
Research Site
Plymouth, Massachusetts, 02360
Research Site
Porterville, California, 93257
Research Site
Portsmouth, New Hampshire, 03801
Research Site
Raleigh, North Carolina, 27609
Research Site
Reno, Nevada, 89511
Research Site
Rochester Hills, Michigan, 48309
Research Site
Saint Clair Shores, Michigan, 48081
Research Site
Salem, Virginia, 24153
Research Site
San Antonio, Texas, 78211
Research Site
San Antonio, Texas, 78251
Research Site
San Diego, California, 92111
Research Site
Shreveport, Louisiana, 71101
Research Site
Springfield, Massachusetts, 01107
Research Site
Tupelo, Mississippi, 38801
Research Site
Woodbridge, Virginia, 22192
About this study
Official title: A Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of anemia in hemodialysis participants.
Read the detailed description
Following randomization, there will be 2 periods during the study:
- Conversion and Maintenance Period (Weeks 0 to 52): There will be a primary efficacy evaluation period (Weeks 20 to 26) and a secondary efficacy evaluation period (Weeks 46 to 52).
- Safety Follow-up Period (Early Termination [ET] and Follow-Up): post-treatment safety follow-up visit (ET/End of Treatment [EOT] +4 weeks) either in person or via telephone.
- Being tested
- Vadadustat, Mircera®
- Keywords
- Anemia, Chronic Kidney Disease, CKD, Hemodialysis, Vadadustat, Erythropoiesis-stimulating agent (ESA)
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VadadustatDrug
oral tablets
Mircera®Drug
intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Vadadustat low dose | Experimental | Participants previously receiving Mircera® received vadadustat for up to 52 weeks with an initial dose of 600 milligrams (mg). Receives: Drug: Vadadustat |
| Vadadustat high dose | Experimental | Participants previously receiving Mircera® received vadadustat for up to 52 weeks with an initial dose of 900 mg. Receives: Drug: Vadadustat |
| Mircera® | Active comparator | Participants will continue to receive Mircera® for up to 52 weeks. Receives: Drug: Mircera® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)
The Baseline Hb was defined as the average of last 2 central laboratory Hb measurements of samples taken at or prior to the first dose. The average for the PEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 20 through 26. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as PEP value minus the Baseline value.
Measured: Baseline; Weeks 20 to 26
Secondary outcomes (1)
Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52)
The Baseline Hb was defined as the average of the last 2 central laboratory Hb values taken on or prior to the first dose date. The average for the SEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 46 through 52. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as SEP value minus the Baseline value.
Measured: Baseline; Weeks 46 to 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start18 Jun 2021
- Primary completion6 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anemia Associated With Chronic Kidney Disease (CKD)Studies 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
- 456 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
- NCT04707768
- Sponsor's protocol ID
- AKB-6548-CI-0039
- Status last verified
- Dec 2024
- First submitted
- 12 Jan 2021
- Last updated
- 15 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toka HR, Bernardo M, Burke SK, Luo W, Manllo-Karim R, Ullah I, Yang Z, Zhang Z, Tumlin J. Vadadustat Three Times Weekly in Patients With Anemia Due to Dialysis-Dependent CKD. Am J Kidney Dis. 2025 Apr;85(4):454-464.e1. doi: 10.1053/j.ajkd.2024.09.006. Epub 2024 Nov 7.
PubMed 39521398Kooienga L, Burke S, Kathresal A, Luo W, Yang Z, Zhang Z, Zwiech R, Hernandez GT. Safety and Efficacy of Vadadustat Once Daily and Three Times Weekly in Patients With Dialysis-Dependent CKD With Anemia. Kidney360. 2024 Nov 1;5(11):1652-1661. doi: 10.34067/KID.0000000567. Epub 2024 Sep 4.
PubMed 39231617
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. 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 and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
- ClinicalTrials.gov ID
- NCT04707768
- Acronym / sponsor ID
- AKB-6548-CI-0039
- Keywords
- Anemia, Chronic Kidney Disease, CKD, Hemodialysis, Vadadustat, Erythropoiesis-stimulating agent (ESA)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Akebia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Posted 15 Jan 2025
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 be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of anemia in hemodialysis participants.
Detailed description
Following randomization, there will be 2 periods during the study:
- Conversion and Maintenance Period (Weeks 0 to 52): There will be a primary efficacy evaluation period (Weeks 20 to 26) and a secondary efficacy evaluation period (Weeks 46 to 52).
- Safety Follow-up Period (Early Termination [ET] and Follow-Up): post-treatment safety follow-up visit (ET/End of Treatment [EOT] +4 weeks) either in person or via telephone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vadadustat low dose | Experimental | Drug: VadadustatParticipants previously receiving Mircera® received vadadustat for up to 52 weeks with an initial dose of 600 milligrams (mg). |
| Vadadustat high dose | Experimental | Drug: VadadustatParticipants previously receiving Mircera® received vadadustat for up to 52 weeks with an initial dose of 900 mg. |
| Mircera® | Active comparator | Drug: Mircera®Participants will continue to receive Mircera® for up to 52 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years of age
- Receiving chronic, outpatient in-center hemodialysis three times weekly (TIW) for end-stage kidney disease for at least 12 weeks prior to Screening Visit 1 (SV1)
- Currently maintained on Mircera® (≤250 μg/month) with at least 2 doses received within 8 weeks prior to Screening Visit 2 (SV2)
- Mean Screening hemoglobin (Hb) between 8.5 and 11.0 grams per deciliter (g/dL) (inclusive), as determined by the average of 2 Hb values measured by the central laboratory at least 4 days apart between SV1 and SV2
- Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening
Key exclusion criteria (8 listed)
- Anemia due to a cause other than chronic kidney disease (CKD).
- Clinically meaningful bleeding event within 8 weeks prior to Baseline
- Red blood cell (RBC) transfusion within 8 weeks prior to Baseline
- Having received any doses of darbepoetin alfa (Aranesp®) within 4 weeks prior to Baseline
- Having received any doses of epoetin alfa (Epogen®) within 1 week prior to Baseline.
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 |
|---|---|---|
| Vadadustatoral tablets | Drug | Vadadustat high dose, Vadadustat low dose |
| Mircera®intravenous administration | Drug | Mircera® |
Primary outcome
Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)
Time frame: Baseline; Weeks 20 to 26
The Baseline Hb was defined as the average of last 2 central laboratory Hb measurements of samples taken at or prior to the first dose. The average for the PEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 20 through 26. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as PEP value minus the Baseline value.
1 secondary outcome
Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52)
Time frame: Baseline; Weeks 46 to 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39521398Toka HR, Bernardo M, Burke SK, Luo W, Manllo-Karim R, Ullah I, Yang Z, Zhang Z, Tumlin J. Vadadustat Three Times Weekly in Patients With Anemia Due to Dialysis-Dependent CKD. Am J Kidney Dis. 2025 Apr;85(4):454-464.e1. doi: 10.1053/j.ajkd.2024.09.006. Epub 2024 Nov 7.
- Derived from this study: PubMed 39231617Kooienga L, Burke S, Kathresal A, Luo W, Yang Z, Zhang Z, Zwiech R, Hernandez GT. Safety and Efficacy of Vadadustat Once Daily and Three Times Weekly in Patients With Dialysis-Dependent CKD With Anemia. Kidney360. 2024 Nov 1;5(11):1652-1661. doi: 10.34067/KID.0000000567. Epub 2024 Sep 4.
- 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
58 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 Mircera® in people with Anemia Associated With Chronic Kidney Disease (CKD), run by Akebia Therapeutics at 58 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 6 inclusion and 8 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 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 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?
Yes. Results are posted in the registry (first posted 15 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26) (time frame: Baseline; Weeks 20 to 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04707768, which also lists 2 linked publications.
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 15 Jan 2025.