NCT04534439已完成2 期
A Randomized, Placebo-controlled, Double-blinded, Multi-centre, Phase 2 Study to Assess Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 16
- 主要终点
- Mean change in urine albumin to creatinine ratio (UACR) in APX-115 group compared to placebo group
研究概览
简要总结
This is a proof of concept (PoC) trial to evaluate the safety, tolerability and renal effect of APX-115 in subjects with Type 2 diabetes and nephropathy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinical Diagnosis of type 2 diabetes and nephropathy
- •First morning void (FMV) UACR between 200 and 3000 mg/g, inclusive
- •30 mL/min/1.73m2 ≤ eGFR ≤ 90 mL/min/1.73m2 using CKD-EPI formula at screening
- •HbA1c ≤ 10% at screening visit
- •Subject who has been taking unchanged dosage of ACE inhibitor or ARB medication for at least 3 months prior to screening and is not anticipated to change its dosage during the course of the study
- •Willing to be under dietary management for diabetes
排除标准
- •History of type 1 diabetes mellitus or gestational diabetes
- •Subject's renal impairment and/or albuminuria is considered to be of origin other than Diabetic Kidney Disease
- •Subject with uncontrolled blood pressure
- •Clinically significant abnormal laboratory findings
- •History of any cardiovascular event within 6 months prior to screening or cardiovascular procedure planned during the clinical trial
- •Diagnostic or interventional procedure requiring a contrast agent within 4 weeks before the screening visit or planned during the course of the study
- •Clinically significant ECG abnormalities on a 12-lead ECG at the screening visit or before randomization
- •Current or history of NYHA class IV heart failure
研究组 & 干预措施
APX-115
Experimental
Oral administration of APX-115 400mg, daily
干预措施: APX-115 (Drug)
Placebo
Placebo Comparator
Oral administration of APX-115-matching placebo 400mg, daily
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change in urine albumin to creatinine ratio (UACR) in APX-115 group compared to placebo group
时间窗: week 12
次要结局
未报告次要终点
研究者
研究点 (16)
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