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An Observational, Cross Sectional Study to Assess the Prevalence of Chronic Kidney Disease (CKD) in Type 2 Diabetes Patients (START-INDIA)

AstraZeneca logo

AstraZeneca

Status

Completed

Conditions

Diabetes

Study type

Observational

Funder types

Industry

Identifiers

NCT02208921
NIS-DIN-XXX-2014/1 (Other Identifier)
D1843R00050

Details and patient eligibility

About

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 (T2DM). 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.

Full description

This is an observational, multicenter, cross-sectional study to be conducted at 30 sites in India. Endocrinologist/ Diabetologist from multiple private clinics will evaluate the Type 2 Diabetes patients. The study will be conducted over 9-10 months and will be started after obtaining written approval of Independent Ethics Committee (IEC) and written Informed consent of the patient. . Each investigative site will be expected to enrol 100 subjects. All the procedures will be completed in a single day.

Enrollment

3,000 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  1. Patients with known type-1 diabetes.
  2. Patients with any form of acute kidney injury based on investigator's discretion.
  3. Patients on maintenance dialysis or known renal transplant patients.
  4. Patients who have participated in any interventional study within past 3 months prior to entry in this study.
  5. Pregnant women.
  6. Patients with symptomatic Urinary Tract Infection (UTI) or with history of hematuria.

Trial design

3,000 participants in 1 patient group

T2DM patients with Chronic Kidney Disease
Description:
T2DM patients with Chronic Kidney Disease

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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