NCT03439137已完成3 期
A Phase III, Double Blind, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 27
- 主要终点
- Mean Hb Level of Week 20 and Week 24
研究概览
简要总结
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 long-term safety of MT-6548.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Darbepoetin alfa
Active Comparator
干预措施: MT-6548-matching placebo (Drug)
MT-6548
Experimental
干预措施: Darbepoetin alfa-matching placebo (Drug)
MT-6548
Experimental
干预措施: MT-6548 (Drug)
Darbepoetin alfa
Active Comparator
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Mean Hb Level of Week 20 and Week 24
时间窗: Up to Week 24
次要结局
- 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)
研究者
研究点 (27)
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