ITMO public health
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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