A Phase 2 Extension of Study GCS-100-CS-4003
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 5
- 主要终点
- Determine the safety and tolerability of extended dosing with a fixed dose of GCS-100 3 mg IV push in patients with CKD (side effects)
研究概览
简要总结
The primary objective of this study is to determine the safety and tolerability of extended dosing with a fixed dose of GCS-100 3 mg IV push in patients with Chronic Kidney Disease (CKD).
详细描述
Galectin-3 contributes to fibrosis, is elevated in patients with ESRD, and correlates with adverse outcomes (de Boer et. al., 2011, Dang et. al., 2012, Fernandes Bertocchi et. al., 2008, Henderson et. al., 2008). Animal models with genetic knockout of galectin-3 demonstrate a reduction in structural and functional deficits in the kidney (Dang et. al., 2012, Fernandes Bertocchi et. al., 2008, Henderson et. al., 2008). GCS-100 is a galectin-3 antagonist that has been shown to reduce fibrosis pre-clinically. Based on the role of galectin-3 and fibrosis in kidney disease, the Sponsor believes GCS-100 may be effective at treating patients with CKD.
This study will consist of a fixed dose of GCS-100 3mg IV push at least every 30 days for a total of 1 year with a follow-up 4 weeks after the last dose is administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent
- •Subject was enrolled in GCS-100-CS-4003.
排除标准
- •Subject experienced a Grade 3 or worse adverse event related to GCS-100 in clinical study GCS-100-CS-
- •Systolic blood pressure ≤90 mmHg and ≥160 mmHg and diastolic blood pressure ≤40 mmHg and ≥100 mmHg at screening
- •Subject has clinical laboratory values of:
- •Hemoglobin: ≤9 g/dL
- •Total bilirubin: >1.5X the upper limit of normal (ULN)
- •ALT and/or AST: >2.5X ULN
- •Subject has a concomitant disease or condition, including laboratory abnormalities, which, in the opinion of the investigator, could interfere with the conduct of the study or put the subject at unacceptable risk.
- •Subject who may require renal replacement therapy within the next 2 months, at the discretion of the investigator.
研究组 & 干预措施
3 mg IV push
GCS-100
干预措施: GCS-100 (Drug)
结局指标
主要结局
Determine the safety and tolerability of extended dosing with a fixed dose of GCS-100 3 mg IV push in patients with CKD (side effects)
时间窗: Participants will be followed for the duration of the study, up to 1 year with a four week additional follow-up period
Evaluate side effects of this therapy when administered for an extended period of time. Determine response to therapy (by measuring kidney function monthly) as compared to subjects' response in study GCS-100-CS-4003. To determine if there are changes in markers (chemicals in the blood) in the blood shown to be related to disease state.
次要结局
未报告次要终点