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Anemia; Non-dialysis Dependent Chronic Kidney DiseasePhase 3NCT03329196

Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

A Phase 3 study testing MT-6548 and Darbepoetin alfa in people with Anemia; Non-dialysis Dependent Chronic Kidney Disease, run by Tanabe Pharma Corporation at 31 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

For Non-dialysis subjects 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
What is being tested?
MT-6548 and Darbepoetin alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
304 participants
Where
31 sitesJapan
Study dates
30 Oct 2017to 9 Aug 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
  • eGFR < 60 mL/min/1.73m^2 during the screening period
  • Not receiving dialysis for 8 weeks prior to the screening period, and not expected to start dialysis during the treatment period
  • Correction group: Not being treated with ESAs for the recent 8 weeks prior to the screening period
  • Conversion group: 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. Correction group: ≥8.0 g/dL and < 11.0 g/dL Conversion group: ≥9.0 g/dL and ≤12.5 g/dL
Show all 9Show fewer
  • 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) during the screening period and Day 1
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  • 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

31 sites in 1 country.

31 sites in 1 country

Japan31 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

    Kagoshima

  • Research site

    Kanagawa

  • Research site

    Kochi

  • Research site

    Kumamoto

  • Research site

    Kyoto

  • Research site

    Miyagi

  • Research site

    Nagano

  • Research site

    Nagasaki

  • Research site

    Nara

  • Research site

    Niigata

  • Research site

    Ōita

  • Research site

    Okayama

  • Research site

    Okinawa

  • Research site

    Osaka

  • Research site

    Saga

  • Research site

    Saitama

  • Research site

    Shiga

  • Research site

    Shizuoka

  • Research site

    Tokyo

  • Research site

    Toyama

  • Research site

    Yamanashi

Other trials in Japan

About this study

Official title: A Phase III, Open-label, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

For Non-dialysis subjects 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.

For subjects not currently receiving ESAs, evaluate Hb correction and maintenance effect of MT-6548 and for subjects currently receiving ESAs, evaluate Hb conversion and maintenance effect of MT-6548

Being tested
MT-6548, Darbepoetin alfa
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

    Subcutaneous

Study groups in NCT03329196
Study groupRoleWhat they receive
MT-6548ExperimentalNot described
Receives: Drug: MT-6548
Darbepoetin alfaActive comparatorNot described
Receives: Drug: Darbepoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Hb Level of Week 20 and Week 24

    Measured: Up to Week 24

Secondary outcomes (5)

  1. Mean Hb Level of Week 48 and Week 52

    Measured: Up to Week 52

  2. Hb Level at Each Assessment Time Point

    Measured: Up to Week 52

  3. Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period

    Measured: Up to Week 52

  4. Time to Reach the Target Hb Range in Correction Group Only

    Measured: Up to Week 52

  5. Rate of Increase in Hb Level in Correction Group Only

    Measured: Up to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2017
  2. Study start30 Oct 2017
  3. Primary completion8 Jan 2019
  4. Study completion9 Aug 2019

Resources

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
304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03329196
Sponsor's protocol ID
MT-6548-J01
Status last verified
Mar 2026
First submitted
30 Oct 2017
Last updated
6 Apr 2026
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Nangaku M, Kondo K, Kokado Y, Ueta K, Kaneko G, Tandai T, Kawaguchi Y, Komatsu Y. Phase 3 Randomized Study Comparing Vadadustat with Darbepoetin Alfa for Anemia in Japanese Patients with Nondialysis-Dependent CKD. J Am Soc Nephrol. 2021 Jul;32(7):1779-1790. doi: 10.1681/ASN.2020091311. Epub 2021 Apr 21.

    PubMed 33883252

  • Nangaku 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 38530490

  • Natale 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MT-6548 and Darbepoetin alfa in people with Anemia; Non-dialysis Dependent Chronic Kidney Disease, run by Tanabe Pharma Corporation at 31 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 9 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 31 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 NCT03329196, 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; AzTrials last refreshed its copy on 26 Oct 2026.

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