跳至主要内容
临床试验/CTRI/2015/05/005769
CTRI/2015/05/005769已完成不适用

An Observational, Cross sectional Study to assess the prevalence of chronic kidney disease in Type 2 Diabetes Patients in India

AstraZeneca Pharma India Ltd30 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2014年9月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,000
试验地点
30
主要终点
To determine the prevalence of Chronic Kidney Disease in patients with T2DM.

研究概览

简要总结

This non-interventional, multi-centric, cross-sectional study is aimed to determine the prevalence of Chronic Kidney Disease in Indian patients with Type 2 diabetes.  Approx 3000 patients will be enrolled from 30 investigative sites all over the country. Each investigative site will be expected to enrol 100 subjects.  All the procedures will be completed in a single day.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • •Known cases of T2DM.
  • •Male and female patients aged 18 years and above •Must provide written Informed consent.

排除标准

  • •Patients with known type-1 diabetes.
  • •Patients with any form of acute kidney injury based on investigator’s discretion.
  • •Patients on maintenance dialysis or known renal transplant patients.
  • •Patients with symptomatic Urinary Tract Infection (UTI) or with history of hematuria.

结局指标

主要结局

To determine the prevalence of Chronic Kidney Disease in patients with T2DM.

时间窗: single visit study (1 day)

次要结局

  • 1.To estimate the proportion of T2DM patients in various Categories of GFR(2.To estimate the proportion of CKD in T2DM patients with different duration of diabetes since diagnosis.)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (30)

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