Last update : 06/30/2022 | Version : 1 | ID : 74134
General | |
Identification | |
Detailed name | Impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with C.E.R.A |
Sign or acronym | MIRIADE |
General Aspects | |
Medical area |
Urology, andrology and nephrology |
Study in connection with Covid-19 |
No |
Pathology (details) | Chronic Kidney Disease on hemodialysis or hemofiltration |
Health determinants |
Iatrogenic Medicine |
Keywords | MIRCERA® |
Scientific investigator(s) (Contact) | |
Name of the director | Roche Medical Data Center |
Address | 4 cours de l'Ile Seguin - 92650 BOULOGNE-BILLANCOURT |
data_sharing_france@roche.com | |
Organization | Roche SAS |
Collaborations | |
Participation in projects, networks and consortia |
No |
Funding | |
Funding status |
Private |
Governance of the database | |
Sponsor(s) or organisation(s) responsible | Roche SAS |
Organisation status |
Private |
Presence of scientific or steering committees |
Yes |
Additional contact | |
Name of the contact | https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html |
Main features | |
Type of database | |
Type of database |
Study databases |
Study databases (details) |
Cohort study |
Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
Database recruitment is is made on the basis of: |
Medication(s) taken |
Database recruitment is carried out as part of an interventional study |
No |
Database objective | |
Main objective |
Primary objective: To describe in CKD patients on dialysis the impact of comorbidities* on hemoglobin stability** after 6 months of treatment with Mircera® in routine clinical practice
* Patients’ comorbidities will be analyzed on the basis of the CCI. ** Hemoglobin stability is defined as a variation of +/- 1g/dL of hemoglobin level between the first Mircera® injection and the 6th month of treatment, without red blood cells transfusion during this period. Secondary objectives: - In the overall study population and in each subgroup of patients defined by a range of the Charlson comorbidity index (<=3, [4-5], [6-7], >=8): - - To describe baseline characteristics of the patients; - - To describe the monthly changes in hemoglobin level; - - To describe monthly Mircera® dose. - To describe patients’ vital status and all adverse events over the observation period with Mircera®; - To describe the hemoglobin stability after 6 months of treatment with Mircera®, according to subgroups of Liu comorbidity index (<=3; [4-6]; [7-9]; >=10); - To describe the proportion of patients with an Hb level within the range 10-12 g/dL with or without hemoglobin stability after 6 months of treatment with Mircera®, according to the subgroups of Charlson and Liu comorbidity indexes. |
Inclusion criteria |
Inclusion criteria:
- Patient aged 18 years or older; - CKD patient on hemodialysis or hemodiafiltration for at least 3 months; - Patient previously treated with an ESA; - Patient for whom the investigator decided to initiate a treatment with Mircera® for medical reasons; - Patient with last hemoglobin level within the range [10 12] g/dL before Mircera® initiation; - Patient having received oral and written information about the study, without any objections for the use of his/her personal data, and having signed a written informed consent form. Exclusion criteria: - Patients participating in a clinical trial on renal anemia at inclusion were excluded from study entry. |
Population type | |
Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
Population covered |
Sick population |
Pathology | N18 - Chronic kidney disease |
Gender |
Male Woman |
Geography area |
National |
Data collection | |
Dates | |
Date of first collection (YYYY or MM/YYYY) | 2014 |
Date of last collection (YYYY or MM/YYYY) | 2015 |
Size of the database | |
Size of the database (number of individuals) |
[500-1000[ individuals |
Details of the number of individuals | 636 |
Data | |
Database activity |
Data collection completed |
Type of data collected |
Clinical data Biological data |
Clinical data (detail) |
Medical registration |
Details of collected clinical data | Demographic - Disease History - Comorbidities - Biology - Previous anemia treatments - Concomitant anemia treatments - Adverse Events. |
Presence of a biobank |
No |
Health parameters studied |
Health care consumption and services |
Care consumption (detail) |
Medicines consumption |
Procedures | |
Data collection method | eCRF |
Classifications used | CDISC |
Quality procedure(s) used | GCP/GVP |
Participant monitoring |
Yes |
Monitoring procedures |
Monitoring by contact with the referring doctor |
Links to administrative sources |
No |
Promotion and access | |
Promotion | |
Access | |
Dedicated website | https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html |
Presence of document that lists variables and coding procedures |
Yes |
Access to aggregated data |
Access on specific project only |
Access to individual data |
Access on specific project only |
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