EUCTR2018-002491-40-DE进行中（未招募）1 期
A randomized patient-and-physician blinded, placebo-controlled,24-week study to assess the safety, tolerability and efficacy of LMB763 in patients with diabetic nephropathy - A study of the safety and efficacy of nidufexor in patients with diabetic
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 116
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male/female patients, 18-75 years
- •Written informed consent
- •Diagnosis of Type 2 diabetes mellitus, with
- •diagnosis made at least 6 months prior to screening
- •Diabetic nephropathy as evidenced by Urine
- •albumin-Cr ratio (UACR) =300 mg/g Cr while
- •receiving a maximally tolerated (optimal) dose of
- •angiotensin converting enzyme inhibitor or
- •angiotensin receptor blocker
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 99
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •History of type 1 diabetes mellitus
- •Severe renal impairment manifesting as serum creatinine eGFR < 30 mL/min/1.73 m^2 at screening
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential, unless allowed by local regulations and they are using highly effective methods of contraception during dosing and for 5 days after stopping study medication
- •Uncontrolled diabetes mellitus
- •History or current diagnosis of ECG abnormalities
- •History of kidney disease other than diabetic nephropathy
研究者
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