A Phase IIb Randomized, Active Comparator-Controlled, Open-Label Clinical Trial to Study the Efficacy and Safety of MK2578 for the Treatment of Anemia in ESA (Erythropoiesis-Stimulating Agent)-Naive Patients With Chronic Kidney Disease Who Are Not on Dialysis.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 主要终点
- Change From Baseline in Hemoglobin Level at Week 4
研究概览
简要总结
This study will define an effective starting dose for subcutaneous administration of MK2578 to correct anemia in erythropoiesis-stimulating agent (ESA)-naive patients with chronic kidney disease (CKD) who are not on dialysis while evaluating its safety.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is male or is a female who either cannot have children or who agrees to use appropriate contraceptive measures
- •Patient has chronic kidney disease
排除标准
- •Patient is morbidly obese
- •Patient has used another erythropoiesis (red blood cell formation) stimulating agent within 12 weeks of screening
- •Patient will require dialysis during the study or is planning to have a kidney transplant within the next 6 months
- •Patient has had a blood transfusion within 12 weeks of screening
- •Patient has had major surgery within the past 12 weeks or plans to have surgery
- •Patient has Human Immunodeficiency Virus (HIV)
- •Patient has a history of diseases other than CKD known to cause anemia
- •Patient has severe congestive heart failure
- •Patient has history of malignant cancer, except certain skin or cervical cancers
- •Patient has a history of grand mal seizures within the last 6 months
- •Patient is pregnant or breastfeeding
研究组 & 干预措施
MK2578 1.0 mcg/kg
MK2578
干预措施: MK2578 (Drug)
MK2578 2.0 mcg/kg
MK2578
干预措施: MK2578 (Drug)
MK2578 3.6 mcg/kg
MK2578
干预措施: MK2578 (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin Level at Week 4
时间窗: 4 weeks
Number of Participants With Composite Events of Death, Myocardial Infarction and Cerebrovascular Accident, Serious Events of Unstable Angina, Transient Ischemic Attack, Arrythmia and Congestive Heart Failure, Peripheral Thrombo-embolic Events
时间窗: 16 Weeks
Number of Participants With Composite Events of Transfusion-related Adverse Experiences
时间窗: 16 Weeks
Number of of Participants With Composite Events of Injection Site Reactions
时间窗: 16 Weeks
Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia
时间窗: 16 Weeks
Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578
时间窗: 16 Weeks
次要结局
- Hemoglobin Concentration After Treatment With MK2578(Weeks 1-10 and Week 12)
- Change From Baseline in Hemoglobin Level(Weeks 1-3, 5-10, and Week 12)
- Number of Participants Who Were Responders(Each week up to 12 weeks)