A Phase II Randomized, Open-Label, Multiple-Rising Dose Clinical Trial to Study the Efficacy and Safety of MK2578 for the Maintenance of Anemia Treatment in Patients With Chronic Kidney Disease Who Are on Hemodialysis.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 39
- 主要终点
- Change From Baseline in Hemoglobin (Hg) Level at Week 4
研究概览
简要总结
This study will evaluate the efficacy and safety of intravenous MK2578, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving erythropoietin stimulating agents.
详细描述
This study consists of a 12-week base study (MK2578-003-AM03) and an optional 40-week extension study (MK2578-003-EXT12). Participants who complete 12 weeks of treatment in the base study will enter the extension on the most recent dose administered in the base study or a newly adjusted dose, if adjustment is required to bring Hg levels within range. Participants' doses of MK2578 will be adjusted upward or downward during the extension study to maintain Hb in the range of 10-12 g/dL.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Base Study:
- •Patient is male or is a female who either cannot have children or who agrees to use appropriate contraceptive measures
- •Patient has been on hemodialysis for at least 6 months when informed consent is signed
- •Patient has received intravenous epoetin alfa or epoetin beta for a least 6 months when the informed consent is signed
- •Extension Study:
- •Patient completed the base study through Week 12
- •Patient tolerated MK2578 and demonstrated compliance with study procedures
排除标准
- •Patient has a life expectancy of less than 6 months
- •Patient is scheduled for 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 12 weeks of screening or plans to have surgery
- •Patient has Human Immunodeficiency Virus (HIV)
- •Patient has history of blood dyscrasia, hematologic disorders or any other disease known to cause anemia
- •Patient has severe congestive heart failure (CHF)
- •Patient has a history of malignant cancer, except certain skin or cervical cancers
- •Patient has a history of grand mal seizures within the last 6 months
研究组 & 干预措施
MK2578 1 mcg for every 600 U of Epogen at Baseline
Participants were randomized to receive treatment every week (QW).
干预措施: MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline (Drug)
1 mcg of MK2578 for every 600 U of Epogen at Baseline
Participants were randomized to receive treatment QM.
干预措施: MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline (Drug)
MK2578 1 mcg for every 350 U of Epogen at Baseline
Participants were randomized to receive treatment QW.
干预措施: MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline (Drug)
1 mcg of MK2578 for every 350 U of Epogen at Baseline
Participants were randomized to receive treatment QM.
干预措施: MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline (Drug)
MK2578 1 mcg for every 200 U of Epogen at Baseline
Participants were randomized to receive treatment QW.
干预措施: MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline (Drug)
1 mcg of MK2578 for every 200 U of Epogen at Baseline
Participants were randomized to receive treatment QM.
干预措施: MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin (Hg) Level at Week 4
时间窗: 4 weeks
Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)
时间窗: 12 weeks
Number of Participants With Composite Events of Transfusion-Related Adverse Experiences
时间窗: 12 weeks
Number of Participants With Composite Events of Infusion Reactions
时间窗: 12 weeks
Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia
时间窗: 12 weeks
Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578
时间窗: 12 weeks
次要结局
- Change From Baseline in Hg Level at Week 12(12 weeks)