A Phase 2 Extension Study of Study GCS-100-CS-4002
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 5
- 主要终点
- Evaluation of Safety
研究概览
简要总结
The primary objective of this study is to determine the safety and tolerability of extended dosing of GCS-100 in patients with CKD.
详细描述
Galectin-3 contributes to fibrosis, is elevated in patients with ESRD, and correlates with adverse outcomes. Animal models with genetic knockout of galectin-3 demonstrate a reduction in structural and functional deficits in the kidney. 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.
Study GCS-100-CS-4002 is an ongoing randomized, placebo controlled study of GCS-100 in Stage 3b and 4 CKD. The objective of the study is to determine the safety and efficacy of 8 weekly injections of GCS-100 on eGFR. Patients who have completed that study without adverse safety events, may be asked to participate in this study to test the safety of prolonged administration of study drug.
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
- Single (Participant)
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 and completed the End of Study (Day 85) of GCS-100-CS-4002
排除标准
- •Subject experienced a Grade 3 or worse adverse event related to GCS-100 in clinical study GCS-100-CS-4002
- •Systolic blood pressure ≤90 mmHg and ≥160 mmHg and diastolic blood pressure ≤40 mmHg and ≤100 mmHg at screening
- •Subject has clinical laboratory results of:
- •Hemoglobin: ≤9g/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
Low Dose GCS-100
Low dose of GCS-100
干预措施: GCS-100 (Drug)
High Dose GCS-100
GCS-100 High dose
干预措施: GCS-100 (Drug)
结局指标
主要结局
Evaluation of Safety
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.
Evaluation of safety measures for long-term dosing including collection of adverse events in clinically significant changes in lab values
次要结局
未报告次要终点