Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 323

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.
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 is ≥9.5 g/dL and ≤12.0 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MT-6548	Darbepoetin alfa-matching placebo	-
MT-6548	MT-6548	-
Darbepoetin alfa	MT-6548-matching placebo	-
Darbepoetin alfa	Darbepoetin alfa	-

Primary Outcome Measures

Name	Time	Method
Mean Hb Level of Week 20 and Week 24	Up to Week 24

Secondary Outcome Measures

Name	Time	Method
Mean Hb Level of Week 48 and Week 52	Up to Week 52
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period	Up to Week 52
Hb Level at Each Assessment Time Point	Up to Week 52