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A non-interventional study to assess the hemoglobin level depending on the comorbidity index in chronic kidney disease (CKD) patients not on dialysis treated with Mircera®

France, 2012 - 2015
Reference ID
FRESH-PEF74126-en
Metadata
DDI/XML JSON
Created on
Nov 15, 2025
Last modified
Nov 15, 2025
Page views
2
  • Study Description
  • Get Microdata
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Data Access
  • Contacts
  • Metadata production
  • Identification

    Survey ID number

    FRESH-PEF74126-en

    Title

    A non-interventional study to assess the hemoglobin level depending on the comorbidity index in chronic kidney disease (CKD) patients not on dialysis treated with Mircera®

    Abbreviation or Acronym

    COMETE

    Country
    Name
    France
    Abstract

    Primary objective : Describe in current medical practice the evolution of hemoglobin levels during the 9-month follow-up in each subgroup defined by the Charlson comorbidity index. Secondary objectives : - Describe the characteristics of patients treated with Mircera® in the total population and in the subgroups defined by the Charlson comorbidity index; - Describe the evolution of the hemoglobin level during the observation period according to the Liu comorbidity index and to ESA resistance factors; - Describe the changes in the Mircera® dosage during the observation period in the total population and in the subgroups defined by the Charlson comorbidity index; - Describe the safety profile of Mircera® during the observation period in the total population and in the subgroups defined by the Charlson comorbidity index.

    Kind of Data

    ['Clinical data','Biological data']

    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary URI
    Nephrology health theme
    cim-11 http://id.who.int/icd/entity/1196874419
    Healthcare system determinants: Use of care health determinant
    Healthcare system determinants health determinant
    Keywords
    MIRCERA®

    Coverage

    Universe

    {
    "level_sex_clusion_I": [
    "Male",
    "Female"
    ],
    "level_age_clusion_I": [
    "Young Adult (19 to 24 years)",
    "Adult (25 to 44 years)",
    "Middle Aged (45 to 64 years)",
    "Aged (65 to 79 years)",
    "Aged, 80 and over (80 years and more)"
    ],
    "level_type_clusion_I": [
    "Patients population"
    ],
    "level_type_clusion_other": "",
    "clusion_I": "",
    "clusion_E": ""
    }

    Producers and sponsors

    Producers
    Name Role
    F. HOFFMANN-LA ROCHE AG sponsor

    Study authorization

    Agency
    Agency name
    Autre

    Sampling

    Sample frame

    Unit Type

    ['Through organizations (health services or institutions, schools, businesses, etc.)']

    Sampling Procedure

    ['Other']

    Survey instrument

    Questionnaires

    Access on specific project only

    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2012 2015
    Time Method

    Longitudinal or cohort study

    Mode of data collection
    • Converting or copying information into a structured record

    Study activities

    Study activities
    Study activities
    Type
    primary evaluation
    Description
    Health event/morbidity Health event/mortality Health care consumption and services

    Quality standards

    Quality standards
    Standard
    ['CDISC']
    Other quality statement

    GCP/GVP

    Data Access

    Availability Status

    Restricted access

    Contacts

    Contacts
    Name Email
    Medical data center data_sharing.france@roche.com

    Metadata production

    DDI Document ID

    FRESH-PEF74126-en

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