Anemia; Peritoneal Dialysis Dependent Chronic Kidney DiseasePhase 3NCT03402386

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

A Phase 3 study testing MT-6548 in people with Anemia; Peritoneal Dialysis Dependent Chronic Kidney Disease, run by Tanabe Pharma Corporation at 17 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

To evaluate the efficacy and safety of MT-6548 in peritoneal dialysis subjects with anemia associated with chronic kidney disease Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Anemia; Peritoneal Dialysis Dependent Chronic Kidney Disease
What is being tested?: MT-6548
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 17 sitesJapan
Study dates: 3 Jan 2018to 20 Dec 2018
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 peritoneal dialysis for more than 4 weeks prior to the screening period. However, receiving hemodialysis is excluded
Not expected to start hemodialysis during the study
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
Peritonitis within 4 weeks prior to the screening period
AST, ALT, or total bilirubin >2.5 x upper limit of normal during the screening period

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Uncontrolled hypertension (diastolic blood pressure >110 mm Hg or systolic blood pressure >180 mm Hg) during the screening period and Day 1
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 (e.g. 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

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

Japan17 sites

Research site
Aichi
Research site
Chiba
Research site
Fukuoka
Research site
Fukushima
Research site
Gunma
Research site
Hokkaido
Research site
Hyōgo
Research site
Ibaraki
Research site
Kagoshima
Research site
Kanagawa
Research site
Kyoto
Research site
Nagano
Research site
Nara
Research site
Okayama
Research site
Okinawa
Research site
Shiga
Research site
Tokyo

Other trials in Japan

About this study

Official title: A Phase III, Open-label Study of MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

To evaluate the efficacy and safety of MT-6548 in peritoneal dialysis subjects with anemia associated with chronic kidney disease

Conditions: Anemia; Peritoneal Dialysis Dependent Chronic Kidney Disease
Being tested: MT-6548
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

Study groups in NCT03402386
Study group	Role	What they receive
MT-6548	Experimental	Not described Receives: Drug: MT-6548

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
Hb Level at Each Assessment Time Point
Measured: Up to Week 24
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Measured: Up to Week 24
Time to Reach the Target Hb Range in Correction Group Only
Measured: Up to Week 24
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.

3 Jan 201820 Dec 2018

First posted18 Jan 2018
Study start3 Jan 2018
Primary completion22 Nov 2018
Study completion20 Dec 2018

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 (1)Papers the sponsor has linked to this study.
Other trials for Anemia; Peritoneal Dialysis 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03402386
Sponsor's protocol ID: MT-6548-J02
Status last verified: Mar 2026
First submitted: 27 Dec 2017
Last updated: 6 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Nangaku M, Kondo K, Takabe S, Ueta K, Kaneko G, Otsuka M, Kawaguchi Y, Komatsu Y. Vadadustat for anemia in chronic kidney disease patients on peritoneal dialysis: A phase 3 open-label study in Japan. Ther Apher Dial. 2021 Oct;25(5):642-653. doi: 10.1111/1744-9987.13611. Epub 2020 Dec 29.
PubMed 33283981

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, Open-label Study of MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
ClinicalTrials.gov ID: NCT03402386
Acronym / sponsor ID: MT-6548-J02
Conditions: Anemia; Peritoneal Dialysis Dependent Chronic Kidney Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: 3 Jan 2018 (actual)
Primary completion: 22 Nov 2018 (actual)
Study completion: 20 Dec 2018 (actual)
First posted: 18 Jan 2018 (actual)
Results: Posted 6 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the efficacy and safety of MT-6548 in peritoneal dialysis subjects with anemia associated with chronic kidney disease

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MT-6548	Experimental	Drug: MT-6548

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Diagnosis of CKD
Receiving peritoneal dialysis for more than 4 weeks prior to the screening period. However, receiving hemodialysis is excluded
Not expected to start hemodialysis during the study
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

Key exclusion criteria (18 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
Peritonitis within 4 weeks prior to 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

Primary outcome

Mean Hb Level of Week 20 and Week 24
Time frame: Up to Week 24
Hb Level at Each Assessment Time Point
Time frame: Up to Week 24
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Time frame: Up to Week 24
Time to Reach the Target Hb Range in Correction Group Only
Time frame: Up to Week 24
Rate of Increase in Hb Level in Correction Group Only
Time frame: Up to Week 6

Results and safety

Results posted to the registry on 6 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MT-6548	42	36

Primary outcome: Mean Hb Level of Week 20 and Week 24

Time frame: Up to Week 24. Least squares mean (95% Confidence Interval). Unit: g/dL

Measure	MT-6548 n = 41
Value	11.35 (10.99 to 11.70)

Population analysed: This analysis was performed in subjects who measured Hb at least one visit after baseline.

Primary outcome: Hb Level at Each Assessment Time Point

Time frame: Up to Week 24. Mean (95% Confidence Interval). Unit: g/dL

Measure	MT-6548 n = 42
Baseline	10.90 (10.56 to 11.25)
Week 2	10.96 (10.54 to 11.38)
Week 4	10.74 (10.31 to 11.17)
Week 6	10.61 (10.09 to 11.13)
Week 8	10.87 (10.41 to 11.33)
Week 10	10.89 (10.45 to 11.32)
Week 12	11.10 (10.67 to 11.53)
Week 16	11.58 (11.12 to 12.04)

Population analysed: This analysis was performed only in subjects who have Hb data at each visit.

Primary outcome: Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period

Time frame: Up to Week 24. Number. Unit: percentage of subjects

Measure	MT-6548 n = 42
Baseline	57.1
Week 2	60.0
Week 4	41.5
Week 6	35.9
Week 8	47.4
Week 10	44.7
Week 12	44.7
Week 16	32.4

Population analysed: This analysis was performed only in subjects who have Hb data at each visit.

Primary outcome: Time to Reach the Target Hb Range in Correction Group Only

Time frame: Up to Week 24

Population analysed: The target number of subjects by correction and conversion group was not pre-specified in the study protocol, and only 2 subjects were enrolled in the correction group as a result. The reason no data have been shown in this column is that this planned analysis wasn't performed due to such insufficient and very small amount of data from the correction group.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MT-6548	12 of 42 (28.6%)	21 of 42 (50%)	1 of 42

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 33283981Nangaku M, Kondo K, Takabe S, Ueta K, Kaneko G, Otsuka M, Kawaguchi Y, Komatsu Y. Vadadustat for anemia in chronic kidney disease patients on peritoneal dialysis: A phase 3 open-label study in Japan. Ther Apher Dial. 2021 Oct;25(5):642-653. doi: 10.1111/1744-9987.13611. Epub 2020 Dec 29.

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

17 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 in people with Anemia; Peritoneal Dialysis Dependent Chronic Kidney Disease, run by Tanabe Pharma Corporation at 17 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 18 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 17 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 6 Jul 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). The study lists 5 primary outcomes in all. 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 NCT03402386, which also lists 1 linked publication.

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.