Anemia; Hemodialysis Dependent Chronic Kidney Disease
Conditions
Brief summary
For hemodialysis subjects not receiving ESAs with anemia associated with chronic kidney disease, evaluate Hb correction and maintenance effect and safety of MT-6548.
Interventions
DRUGMT-6548
Oral tablet
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Hb Level of Week 20 and Week 24 | Up to Week 24 |
| Hb Level at Each Assessment Time Point | Up to Week 24 |
| Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period | Up to Week 24 |
| Time to Reach the Target Hb Range | Up to Week 24 |
| Rate of Increase in Hb Level | Up to Week 6 |
Countries
Japan
Contacts
STUDY_DIRECTORGeneral Manager
Tanabe Pharma Corporation
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MT-6548 MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | MT-6548 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Race/Ethnicity, Customized Asian (Japanese) | 24 Participants |
| Race/Ethnicity, Customized Asian (Other) | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 15 / 24 |
| serious Total, serious adverse events | 7 / 24 |
Outcome results
Primary
Hb Level at Each Assessment Time Point
Time frame: Up to Week 24
Population: This analysis was performed only in subjects who have Hb data at each visit.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MT-6548 | Hb Level at Each Assessment Time Point | Baseline | 9.15 g/dL |
| MT-6548 | Hb Level at Each Assessment Time Point | Week 2 | 9.25 g/dL |
| MT-6548 | Hb Level at Each Assessment Time Point | Week 4 | 9.53 g/dL |
| MT-6548 | Hb Level at Each Assessment Time Point | Week 6 | 9.90 g/dL |
| MT-6548 | Hb Level at Each Assessment Time Point | Week 8 | 10.33 g/dL |
| MT-6548 | Hb Level at Each Assessment Time Point | Week 10 | 10.56 g/dL |
| MT-6548 | Hb Level at Each Assessment Time Point | Week 12 | 10.68 g/dL |
| MT-6548 | Hb Level at Each Assessment Time Point | Week 16 | 11.17 g/dL |
| MT-6548 | Hb Level at Each Assessment Time Point | Week 20 | 11.08 g/dL |
| MT-6548 | Hb Level at Each Assessment Time Point | Week 24 | 11.03 g/dL |
| MT-6548 | Hb Level at Each Assessment Time Point | Week 24 (LOCF) | 10.56 g/dL |
Primary
Mean Hb Level of Week 20 and Week 24
Time frame: Up to Week 24
Population: This analysis was performed in subjects who measured Hb at least one visit after baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| MT-6548 | Mean Hb Level of Week 20 and Week 24 | 10.75 g/dL |
Primary
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
Population: This analysis was performed only in subjects who have Hb data at each visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MT-6548 | Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period | Baseline | 16.7 percentage of subjects |
| MT-6548 | Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period | Week 2 | 21.7 percentage of subjects |
| MT-6548 | Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period | Week 4 | 36.4 percentage of subjects |
| MT-6548 | Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period | Week 6 | 47.6 percentage of subjects |
| MT-6548 | Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period | Week 8 | 55.0 percentage of subjects |
| MT-6548 | Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period | Week 10 | 63.2 percentage of subjects |
| MT-6548 | Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period | Week 12 | 68.4 percentage of subjects |
| MT-6548 | Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period | Week 16 | 63.2 percentage of subjects |
| MT-6548 | Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period | Week 20 | 78.9 percentage of subjects |
| MT-6548 | Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period | Week 24 | 73.7 percentage of subjects |
Primary
Rate of Increase in Hb Level
Time frame: Up to Week 6
Population: This analysis was performed in subjects who measured Hb up to week 4 or week 6.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MT-6548 | Rate of Increase in Hb Level | Calculated based on Hb at baseline and Week 4 | 0.05 g/dL/week |
| MT-6548 | Rate of Increase in Hb Level | Calculated based on Hb up to Week6 | 0.09 g/dL/week |
Primary
Time to Reach the Target Hb Range
Time frame: Up to Week 24
Population: This analysis was performed except for subjects with Hb of 10.0 g/dL or more at baseline.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MT-6548 | Time to Reach the Target Hb Range | 67.2 days |