jRCT1080225017已完成2 期
A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison, Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of SCO-792 in Subjects with Type 2 Diabetes and Albuminuria.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AE)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- A Randomized, Multi-center, Doubleblind,placebo-controlled, Parallelgroup, Comparison
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 75age old under（—）
- 性别
- All
入选标准
- •The subject signs and dates a written, informed consent form prior to the initiation of any study procedures
- •The subject is capable of understanding and complying with protocol requirements
- •The subject is either male or female and aged 18 to 75 years (inclusive) at signing of informed consent
- •The subject has been treated with stable doses of the same RAS inhibitors for at least 3 months prior to Visit 1
- •The subject has been treated with stable doses of AHA monotherapy or combination therapy for at least 3 months prior to Visit 1
- •The subject has UACR >=200 mg/gCr to <5000 mg/gCr
- •The subject has a HbA1c =< 10.5%
排除标准
- •The subject has a history of type 1 diabetes mellitus
- •The subject has a confirmed diagnosis of a renal disease other than type 2 DKD (eg, lupus nephritis, primary focal segmental glomerulosclerosis, acute or chronic glomerular nephritis, bilateral or unilateral renal artery stenosis or polycystic kidney disease). Concomitant hypertensive nephrosclerosis is not prohibited
结局指标
主要结局
Incidence and severity of adverse events (AE)
Incidence and severity of adverse events (AE)
Incidence of serious adverse events
Incidence of serious adverse events
Clinically significant changes from baseline
Clinically significant changes from baseline in: - Clinical laboratory tests - 12-lead electrocardiograms - vital signs - physical examinations
Incidence and severity of hypoglycemia and hyperglycemia
Incidence and severity of hypoglycemia and hyperglycemia
Change in log-transformed UACR from baseline
时间窗: Week 12
Change in log-transformed UACR from baseline at the completion of the treatment period (Week 12)
次要结局
- Change in eGFR value from baseline(Week 12)
- Responder rate (UACR decreased by>= 30%) from baseline(Week 12)
研究者
研究点 (1)
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