New pill could help dialysis patients fight anemia without needles
NCT ID NCT03461146
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tested an oral drug called vadadustat (MT-6548) in 24 Japanese adults on hemodialysis who had anemia due to chronic kidney disease. The goal was to see if the drug could raise and maintain healthy hemoglobin levels safely. Participants took the tablet daily, and researchers tracked blood counts and side effects over several months.
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), an oral tablet
- What this could lead to
- If successful, this could offer a new oral option to manage anemia in people on dialysis, potentially reducing the need for injections of erythropoiesis-stimulating agents.
- What could go wrong
- This is a small, early-phase study in Japan only, so results may not apply broadly. The drug may not work as well as expected or could have side effects like high blood pressure or blood clots.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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24 people
The number who actually took part.
- Started
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Mar 2018
- Finished
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Dec 2018
- Lead sponsor
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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
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 * 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. * Not being treated with ESAs or if being treated with ESAs, leave defined interval between last ESAs administration and the first day of the screening period * Mean of the two screening Hb levels closest in time to the baseline visit is ≥8.0 g/dL and \<10.0 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 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) at the first day of 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research site
Aichi, Japan
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Research site
Chiba, Japan
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Research site
Fukushima, Japan
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Research site
Gunma, Japan
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Research site
Hokkaido, Japan
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Research site
Hyōgo, Japan
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Research site
Ibaraki, Japan
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Research site
Kagoshima, Japan
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Research site
Nagano, Japan
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Research site
Okayama, Japan
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Research site
Okinawa, Japan
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Research site
Osaka, Japan
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Research site
Saitama, Japan
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Research site
Shiga, Japan
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Research site
Shizuoka, Japan
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Research site
Yamagata, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A pill vs. a shot: which eases Kidney-Related anemia better?
- Can a pill replace EPO shots for anemia in kidney disease?
- New oral drug could replace injections for kidney anemia
- New pill could replace needles for anemia in dialysis patients
- New pill could help kidney patients fight anemia without needles
- New anemia pill challenges standard shot for dialysis patients