Status:
COMPLETED
Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Anemia; Hemodialysis Dependent Chronic Kidney Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
For hemodialysis subjects currently receiving ESAs with anemia associated with chronic kidney disease, demonstrate non-inferiority of MT-6548 compared to darbepoetin alfa using Hb value and evaluate l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2019
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT03439137
Start Date
February 14 2018
End Date
July 16 2019
Last Update
January 7 2026
Active Locations (28)
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1
Research site
Aichi, Japan
2
Research site
Chiba, Japan
3
Research site
Fukui, Japan
4
Research site
Fukuoka, Japan