NCT00750295已完成1 期
An Open Label, Multiple Dose, Time-lagged, Switch Study to Evaluate the Safety, Tolerability and Activity of Escalating SBR759 Doses in Patients With Chronic Kidney Disease on Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- In addition to the standard safety assessments (vital signs, ECGs, clinical chemistry and adverse events), serum phosphorus concentration is frequently measured during the study.
研究概览
简要总结
The primary objective of this study is to assess the safety, tolerability and activity of escalating multiple doses of SBR759 in patients with chronic kidney disease on hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be treated with maintenance hemodialysis and prescribed a phosphate binder.
- •A controlled serum phosphorus.
- •Constant dose of concomitant medications.
- •Women of child bearing potential must be practicing an acceptable form of birth control (i.e. double barrier method - intrauterine device plus condom, spermicidal gel plus condom). All female patients must have a negative pregnancy test at screening in order to be eligible to participate in the study.
排除标准
- •Patient has been hospitalized within 30 days prior to screening or has a surgery scheduled during the study.
- •Patient has an unstable medical condition, an active infection, active malignancy (except for basal cell carcinoma of the skin), a history of major GI tract surgery, or a history of hemochromatosis.
- •Patient is receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to screening.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
1
Experimental
干预措施: SBR759 (Drug)
2
Experimental
干预措施: SBR759 (Drug)
3
Experimental
干预措施: SBR759 (Drug)
4
Experimental
干预措施: SBR759 (Drug)
5
Experimental
干预措施: SBR759 (Drug)
6
Experimental
干预措施: SBR759 (Drug)
7
Experimental
干预措施: SBR759 (Drug)
结局指标
主要结局
In addition to the standard safety assessments (vital signs, ECGs, clinical chemistry and adverse events), serum phosphorus concentration is frequently measured during the study.
次要结局
- Several biomarkers and patient-reported outcomes are assessed at specified time points, before and after treating patients with the study drug.
研究者
研究点 (1)
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