FRESH-PEF74126-en
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®
COMETE
| Name |
|---|
| France |
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.
['Clinical data','Biological data']
Individuals
| 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 |
{
"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": ""
}
| Name | Role |
|---|---|
| F. HOFFMANN-LA ROCHE AG | sponsor |
| Agency name |
|---|
| Autre |
['Through organizations (health services or institutions, schools, businesses, etc.)']
['Other']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2012 | 2015 |
Longitudinal or cohort study
| Standard |
|---|
| ['CDISC'] |
GCP/GVP
Restricted access
| Name | |
|---|---|
| Medical data center | data_sharing.france@roche.com |
FRESH-PEF74126-en