EUCTR2009-016376-76-BG进行中（未招募）不适用
A Phase II Extension of a Randomized, Open-Label, Multiple-Rising Dose Clinical Trial to Study the Efficacy and Safety of MK-2578 for the Maintenance of Anemia Treatment in Patients with Chronic Kidney Disease who are on Hemodialysis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must meet each of the following criteria to participate in the extension study:
- •Patient met all entry criteria for MK-2578 in the base study (Protocol 003) and completed the base study per-protocol through Visit 18 (Treatment Week 12)
- •Patient tolerated MK-2578 and, in the opinion of the investigator and clinical monitor, demonstrated compliance with study procedures.
- •Patient agrees to commit to the visit schedule required over the entire 40 weeks of this extension study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients are excluded from participating in the extension study if they meet any of the following criteria:
- •Patient has developed any medicial condition or disorder during the base study that, in the opinion of the investigator or Clinical Monitor, might pose a risk to the patient.
- •Note: Patients whose dose of MK-2578 remained on hold at the time of completion of the base study, due to Hb values =14.0 g/dL, are eligible to enter this extension. Furthermore, patients in the base study who experienced a serious adverse event that did not disqualify them from the base study are eligible to enroll in this extension; in these cases, the investigators should use their discretion in determining eligibility.
研究者
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