A Phase 3 interventional study of MT-6548 in Anemia; Hemodialysis Dependent Chronic Kidney Disease, sponsored by Tanabe Pharma Corporation. Completed at 16 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Tanabe Pharma Corporation · Phase 3, Interventional, and Treatment
For hemodialysis subjects not receiving ESAs with anemia associated with chronic kidney disease, evaluate Hb correction and maintenance effect and safety of MT-6548.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's enrollment of 24 is below the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →Tanabe Pharma Corporation is the lead sponsor of 92 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Ophthalmic examinations during the screening period correspond to either of the following criteria;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: MT-6548
Oral tablet
Also known as: vadadustat, AKB-6548
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
Time frame: Up to Week 24
Rate of Increase in Hb Level
Time frame: Up to Week 6
| Milestone | MT-6548 |
|---|---|
| Started | 24 |
| Completed | 21 |
| Not completed | 3 |
| Withdrew: Adverse event | 2 |
| Withdrew: Physician decision | 1 |
| g/dL | MT-6548 |
|---|---|
| Mean Hb Level of Week 20 and Week 24 | 10.75 (10.35 to 11.14) |
| g/dL | MT-6548 |
|---|---|
| Baseline | 9.15 (8.73 to 9.57) |
| Week 2 | 9.25 (8.83 to 9.68) |
| Week 4 | 9.53 (9.03 to 10.04) |
| Week 6 | 9.90 (9.37 to 10.43) |
| Week 8 | 10.33 (9.80 to 10.85) |
| Week 10 | 10.56 (10.08 to 11.04) |
| Week 12 | 10.68 (10.18 to 11.19) |
| Week 16 | 11.17 (10.66 to 11.68) |
| Week 20 | 11.08 (10.73 to 11.43) |
| Week 24 | 11.03 (10.60 to 11.45) |
| Week 24 (LOCF) | 10.56 (9.95 to 11.17) |
| percentage of subjects | MT-6548 |
|---|---|
| Baseline | 16.7 |
| Week 2 | 21.7 |
| Week 4 | 36.4 |
| Week 6 | 47.6 |
| Week 8 | 55.0 |
| Week 10 | 63.2 |
| Week 12 | 68.4 |
| Week 16 | 63.2 |
| Week 20 | 78.9 |
| Week 24 | 73.7 |
| days | MT-6548 |
|---|---|
| Time to Reach the Target Hb Range | 67.2 (45.8 to 88.6) |
| g/dL/week | MT-6548 |
|---|---|
| Calculated based on Hb at baseline and Week 4 | 0.05 (-0.05 to 0.16) |
| Calculated based on Hb up to Week6 | 0.09 (0.01 to 0.17) |
Collected over 24 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MT-6548 | 0/24 (0%) | 7/24 (29.2%) | 15/24 (62.5%) |
| Event | MT-6548 |
|---|---|
| Duodenal ulcer haemorrhageGastrointestinal disorders | 1/24 |
| PneumoniaInfections and infestations | 1/24 |
| Arteriovenous fistula occlusionInjury, poisoning and procedural complications | 1/24 |
| Clavicle fractureInjury, poisoning and procedural complications | 1/24 |
| Pelvic fractureInjury, poisoning and procedural complications | 1/24 |
| Shunt stenosisInjury, poisoning and procedural complications | 1/24 |
| Vascular access malfunctionInjury, poisoning and procedural complications | 1/24 |
| AneurysmVascular disorders | 1/24 |
| Peripheral arterial occlusive diseaseVascular disorders | 1/24 |
| Event | MT-6548 |
|---|---|
| NasopharyngitisInfections and infestations | 5/24 |
| Shunt stenosisInjury, poisoning and procedural complications | 5/24 |
| DiarrhoeaGastrointestinal disorders | 4/24 |
| Skin abrasionInjury, poisoning and procedural complications | 3/24 |
| VomitingGastrointestinal disorders | 2/24 |
| Age, Categorical(Participants) | MT-6548 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 13 |
| Sex: Female, Male(Participants) | MT-6548 |
|---|---|
| Female | 5 |
| Male | 19 |
| Race/Ethnicity, Customized(Participants) | MT-6548 |
|---|---|
| Asian (Japanese) | 24 |
| Asian (Other) | 0 |
| Other | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vadadustat