Anemia; Hemodialysis Dependent Chronic Kidney DiseasePhase 3NCT03439137
Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan
A Phase 3 study testing MT-6548 and Darbepoetin alfa in people with Anemia; Hemodialysis Dependent Chronic Kidney Disease, run by Tanabe Pharma Corporation at 28 sites in Japan.
Trial summary
For hemodialysis subjects currently receiving ESAs with anemia associated with chronic kidney disease, demonstrate non-inferiority of MT-6548 compared to darbepoetin alfa using Hb value and evaluate long-term safety of MT-6548. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anemia; Hemodialysis Dependent Chronic Kidney Disease
- What is being tested?
- MT-6548 and Darbepoetin alfa
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 323 participants
- Where
- 28 sitesJapan
- Study dates
- 14 Feb 2018to 16 Jul 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CKD
- Receiving hemodialysis or hemodiafiltration 3 times a week for more than 12 weeks prior to the screening period, excluding receiving home dialysis or combination of peritoneal dialysis.
- Being treated with ESAs for the recent 8 weeks prior to the screening period
- Mean of the two screening Hb levels closest in time to the baseline visit is ≥9.5 g/dL and ≤12.0 g/dL
- Fluctuation between the two Hb levels closest in time to the baseline visit during the screening period less than 1.5 g/dL
- Serum ferritin ≥ 100 ng/mL, or TSAT ≥20% during the screening period
- Folate and vitamin B12 ≥ lower limit of normal during the screening period
Who cannot join
- Anemia due to a main cause other than CKD: sickle cell disease, myelodysplastic syndrome, bone marrow fibrosis, hematologic malignancy, hemolytic anemia, thalassemia, or pure red cell aplasia
- Active bleeding or recent blood loss within 8 weeks prior to the screening period
- RBC transfusion within 8 weeks prior to the screening period
- Received testosterone enanthate or mepitiostane within 8 weeks prior to the screening period
- AST, ALT, or total bilirubin >2.5 x upper limit of normal during the screening period
- Uncontrolled hypertension (diastolic blood pressure >110 mm Hg or systolic blood pressure >180 mm Hg) at the first day of the screening period and Day 1
Show all 17Show fewer
- Ophthalmic examinations during the screening period correspond to either of the following criteria;
- No available fundal findings
- Findings indicating the presence of active fundal disease
- Severe heart failure (New York Heart Association Class IV)
- Cerebrovascular disorder or acute coronary syndrome (hospitalization due to unstable angina or myocardial infarction), requiring hospitalization due to urgent percutaneous intervention for coronary or heart failure within 12 weeks prior to the screening period
- Current or history of malignancy. History of malignancy with no recurrence for the recent 5 years is not an exclusion criterion
- New onset or recurrent event of deep vein thrombosis or pulmonary embolism within 12 weeks prior to the screening period
- Current or history of hemosiderosis or hemochromatosis
- History of prior organ transplantation or scheduled organ transplant, or prior transplantation of hematopoietic stem cell or bone marrow
- Males and females of childbearing potential who are unwilling to use an acceptable method of contraception during the designated period (Males: during the study and 90 days after the last dose, females: during study and 30 days after the last dose)
- Females who are pregnant or breast feeding, or are predicted to be pregnant
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Japan28 sites
Research site
Aichi
Research site
Chiba
Research site
Fukui
Research site
Fukuoka
Research site
Fukushima
Research site
Gunma
Research site
Hiroshima
Research site
Hokkaido
Research site
Hyōgo
Research site
Ibaraki
Research site
Kagawa
Research site
Kagoshima
Research site
Kanagawa
Research site
Kumamoto
Research site
Kyoto
Research site
Miyagi
Research site
Nagano
Research site
Nagasaki
Research site
Ōita
Research site
Okayama
Research site
Okinawa
Research site
Osaka
Research site
Saitama
Research site
Shiga
Research site
Shizuoka
Research site
Tokushma
Research site
Tokyo
Research site
Yamagata
About this study
Official title: A Phase III, Double Blind, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
For hemodialysis subjects currently receiving ESAs with anemia associated with chronic kidney disease, demonstrate non-inferiority of MT-6548 compared to darbepoetin alfa using Hb value and evaluate long-term safety of MT-6548.
- Being tested
- MT-6548, Darbepoetin alfa, MT-6548-matching placebo, Darbepoetin alfa-matching placebo
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-6548Drug
Also called vadadustat, AKB-6548
Oral tablet
Darbepoetin alfaDrug
Intravenous administration
MT-6548-matching placeboDrug
Oral tablet
Darbepoetin alfa-matching placeboDrug
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| MT-6548 | Experimental | Not described Receives: Drug: MT-6548; Drug: Darbepoetin alfa-matching placebo |
| Darbepoetin alfa | Active comparator | Not described Receives: Drug: Darbepoetin alfa; Drug: MT-6548-matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Hb Level of Week 20 and Week 24
Measured: Up to Week 24
Secondary outcomes (3)
Mean Hb Level of Week 48 and Week 52
Measured: Up to Week 52
Hb Level at Each Assessment Time Point
Measured: Up to Week 52
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start14 Feb 2018
- Primary completion12 Dec 2018
- Study completion16 Jul 2019
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 (3)Papers the sponsor has linked to this study.
- Other trials for Anemia; Hemodialysis Dependent 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Tanabe Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439137
- Sponsor's protocol ID
- MT-6548-J03
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2018
- Last updated
- 6 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nangaku M, Kondo K, Ueta K, Kokado Y, Kaneko G, Matsuda H, Kawaguchi Y, Komatsu Y. Efficacy and safety of vadadustat compared with darbepoetin alfa in Japanese anemic patients on hemodialysis: a Phase 3, multicenter, randomized, double-blind study. Nephrol Dial Transplant. 2021 Aug 27;36(9):1731-1741. doi: 10.1093/ndt/gfab055.
PubMed 33650630Nangaku M, Ueta K, Nishimura K, Sasaki K, Hashimoto T. Factors affecting responsiveness of vadadustat in patients with anemia associated with chronic kidney disease: a post-hoc subgroup analysis of Japanese phase 3 randomized studies. Clin Exp Nephrol. 2024 May;28(5):391-403. doi: 10.1007/s10157-023-02432-z. Epub 2024 Mar 26.
PubMed 38530490Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
PubMed 36005278
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double Blind, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
- ClinicalTrials.gov ID
- NCT03439137
- Acronym / sponsor ID
- MT-6548-J03
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Posted 12 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For hemodialysis subjects currently receiving ESAs with anemia associated with chronic kidney disease, demonstrate non-inferiority of MT-6548 compared to darbepoetin alfa using Hb value and evaluate long-term safety of MT-6548.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT-6548 | Experimental | Drug: MT-6548, Drug: Darbepoetin alfa-matching placebo |
| Darbepoetin alfa | Active comparator | Drug: Darbepoetin alfa, Drug: MT-6548-matching placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of CKD
- Receiving hemodialysis or hemodiafiltration 3 times a week for more than 12 weeks prior to the screening period, excluding receiving home dialysis or combination of peritoneal dialysis.
- Being treated with ESAs for the recent 8 weeks prior to the screening period
- Mean of the two screening Hb levels closest in time to the baseline visit is ≥9.5 g/dL and ≤12.0 g/dL
- Fluctuation between the two Hb levels closest in time to the baseline visit during the screening period less than 1.5 g/dL
Key exclusion criteria (17 listed)
- Anemia due to a main cause other than CKD: sickle cell disease, myelodysplastic syndrome, bone marrow fibrosis, hematologic malignancy, hemolytic anemia, thalassemia, or pure red cell aplasia
- Active bleeding or recent blood loss within 8 weeks prior to the screening period
- RBC transfusion within 8 weeks prior to the screening period
- Received testosterone enanthate or mepitiostane within 8 weeks prior to the screening period
- AST, ALT, or total bilirubin >2.5 x upper limit of normal during the screening period
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 |
|---|---|---|
| MT-6548Also: vadadustat, AKB-6548Oral tablet | Drug | MT-6548 |
| Darbepoetin alfaIntravenous administration | Drug | Darbepoetin alfa |
| MT-6548-matching placeboOral tablet | Drug | Darbepoetin alfa |
| Darbepoetin alfa-matching placeboIntravenous administration | Drug | MT-6548 |
Primary outcome
Mean Hb Level of Week 20 and Week 24
Time frame: Up to Week 24
3 secondary outcomes
Mean Hb Level of Week 48 and Week 52
Time frame: Up to Week 52
Hb Level at Each Assessment Time Point
Time frame: Up to Week 52
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Time frame: Up to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33650630Nangaku M, Kondo K, Ueta K, Kokado Y, Kaneko G, Matsuda H, Kawaguchi Y, Komatsu Y. Efficacy and safety of vadadustat compared with darbepoetin alfa in Japanese anemic patients on hemodialysis: a Phase 3, multicenter, randomized, double-blind study. Nephrol Dial Transplant. 2021 Aug 27;36(9):1731-1741. doi: 10.1093/ndt/gfab055.
- Derived from this study: PubMed 38530490Nangaku M, Ueta K, Nishimura K, Sasaki K, Hashimoto T. Factors affecting responsiveness of vadadustat in patients with anemia associated with chronic kidney disease: a post-hoc subgroup analysis of Japanese phase 3 randomized studies. Clin Exp Nephrol. 2024 May;28(5):391-403. doi: 10.1007/s10157-023-02432-z. Epub 2024 Mar 26.
- Derived from this study: PubMed 36005278Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Related trials for Anemia; Hemodialysis Dependent Chronic Kidney Disease
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.
General Manager study director
Tanabe Pharma Corporation
28 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 MT-6548 and Darbepoetin alfa in people with Anemia; Hemodialysis Dependent Chronic Kidney Disease, run by Tanabe Pharma Corporation at 28 sites in Japan.
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 7 inclusion and 17 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Japan. 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 12 Apr 2021). 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?
Mean Hb Level of Week 20 and Week 24 (time frame: Up to Week 24). 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 NCT03439137, which also lists 3 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 6 Apr 2026.