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Pill could replace needles for Kidney-Related anemia

NCT ID NCT03329196

Disease control Sponsor: Tanabe Pharma Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested an oral drug called MT-6548 (vadadustat) against a standard injected drug (darbepoetin alfa) for anemia in people with chronic kidney disease who are not on dialysis. The study enrolled 304 participants in Japan to see if the oral drug is at least as good at maintaining healthy hemoglobin levels and to check its long-term safety. The goal is to offer a more convenient pill option for managing anemia in this condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vadadustat (MT-6548) oral tablet
What this could lead to
If successful, this could offer a convenient oral alternative to injected darbepoetin for managing anemia in chronic kidney disease patients not on dialysis.
What could go wrong
This is a confirmatory trial in Japan only, so results may not apply globally. Non-inferiority does not guarantee superiority, and long-term safety data are still limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

304 people

The number who actually took part.

Started

Oct 2017

Finished

Aug 2019

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

anemia anemia due to chronic disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia; non-dialysis dependent chronic kidney disease

Contacts and locations

Locations

  • Research site

    Ibaraki, Japan

  • Research site

    Kagoshima, Japan

  • Research site

    Kanagawa, Japan

  • Research site

    Kochi, Japan

  • Research site

    Kumamoto, Japan

  • Research site

    Kyoto, Japan

  • Research site

    Miyagi, Japan

  • Research site

    Nagano, Japan

  • Research site

    Nagasaki, Japan

  • Research site

    Nara, Japan

  • Research site

    Niigata, Japan

  • Research site

    Okayama, Japan

  • Research site

    Okinawa, Japan

  • Research site

    Osaka, Japan

  • Research site

    Ōita, Japan

  • Research site

    Saga, Japan

  • Research site

    Saitama, Japan

  • Research site

    Shiga, Japan

  • Research site

    Shizuoka, Japan

  • Research site

    Tokyo, Japan

  • Research site

    Toyama, Japan

  • Research site

    Yamanashi, Japan

  • Research site

    Aichi, Japan

  • Research site

    Chiba, Japan

  • Research site

    Fukui, Japan

  • Research site

    Fukuoka, Japan

  • Research site

    Fukushima, Japan

  • Research site

    Gunma, Japan

  • Research site

    Hiroshima, Japan

  • Research site

    Hokkaido, Japan

  • Research site

    Hyōgo, Japan

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