LBCTR2019020193已完成2 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
ovartis Pharma Services Inc.0 个研究点目标入组 5 人开始时间: 2022年3月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •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
排除标准
- •Exclusion Criteria:
- •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 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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