跳至主要内容
临床试验/jRCT2031210055
jRCT2031210055进行中(未招募)不适用

Randomised, double-blind (within dose groups), placebo-controlled and parallel group trial to investigate the effects of different doses of oral BI 685509 given over 20 weeks on UACR reduction in patients with diabetic kidney disease

Nippon Boehringer Ingelheim Co., Ltd.0 个研究点目标入组 240 人开始时间: 2021年6月16日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
240
主要终点
Change from baseline in log transformed UACR

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
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Double Blind

入排标准

年龄范围
18age old over 至 No limit(—)
性别
All

入选标准

  • Male or female patients of legal adult age (according to local legislation) at time of consent.
  • eGFR of 20 and more amd less than 90 mL/min/1.73 m
  • UACR of 200 and more and less than 3,500 mg/g.
  • Stable treatment with either ACEi or ARB (not both).
  • Patients with stable type 1 or type 2 diabetes mellitus.

排除标准

  • Non-diabetic chronic kidney disease.
  • planned start of chronic renal replacement therapy during the trial or end stage renal disease before start of trial treatment.

结局指标

主要结局

Change from baseline in log transformed UACR

时间窗: after 20 weeks of trial treatment

Measured in 10-hour urine

次要结局

未报告次要终点

研究者

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