check_circleStudy Completed

Type 2 diabetes mellitus, Chronic kidney disease

OREOT – Observational Retrospective pharmaco-Epidemiological French study On CKD in T2DM disease

Trial purpose

L'objectif principal de cette étude est d'évaluer la prévalence et l'incidence des patients atteints de maladie rénale chronique et de diabète de type 2 dans la population française.
Les objectifs secondaires de l’étude sont :
•   D’évaluer la prévalence et l'incidence de sous-populations d'intérêt chez les patients atteints de maladie rénale chronique et de diabète de type 2 ;
•   De décrire chez les patients atteints de maladie rénale chronique et de diabète de type 2 et selon le stade de l’atteinte rénale :
- Les caractéristiques démographiques et cliniques des patients.
- Les traitements médicamenteux.
- L'incidence des complications rénales et cardiovasculaires.
- L'utilisation et les coûts des soins de santé.

Key Participants Requirements

Sex

All

Age

30 - N/A

Trial summary

Enrollment Goal
30000
Trial Dates
October 2020 - February 2024
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Many LocationsMany Locations, France

Primary Outcome

  • Prevalence and incidence of Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM) patients in the French population and in sub-populations of interest
    date_rangeTime Frame:
    Secondary data collection between 2014 and 2018

Secondary Outcome

  • Demographic and clinical characteristics of patients at baseline
    date_rangeTime Frame:
    Secondary data collection between 2014 and 2018
  • Description of treatment pattern
    date_rangeTime Frame:
    Secondary data collection between 2014 and 2018
  • Description of time to outcomes: hospitalization for cardiovascular events, end-stage renal disease (ESRD), mortality
    date_rangeTime Frame:
    Secondary data collection between 2014 and 2018
  • Quantify healthcare resources utilization and costs of Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD) patients
    date_rangeTime Frame:
    Secondary data collection between 2014 and 2018
  • Health care workers involved in patients management
    date_rangeTime Frame:
    Secondary data collection between 2014 and 2018
  • Global cost and additional cost of Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM) patients
    date_rangeTime Frame:
    Secondary data collection between 2014 and 2018

Trial design

OREOT – Observational Retrospective pharmaco-Epidemiological French study On CKD in T2DM disease
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A