HORTENSIA - Cohort study in chronic kidney disease patients on dialysis starting treatment with Mircera® to correct anemia or maintain stable hemoglobin levels

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Roche Medical Data Center

Last update : 06/30/2022 | Version : 1 | ID : 74133

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Cohort study in chronic kidney disease patients on dialysis starting treatment with Mircera® to correct anemia or maintain stable hemoglobin levels
Sign or acronym HORTENSIA
General Aspects
Medical area Urology, andrology and nephrology
Study in connection with Covid-19 No
Pathology (details) Chronic Kidney Disease on dialysis
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
Email 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 Public
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: Describe the management of anemia treatment with Mircera® in routine clinical practice in chronic kidney disease patients on dialysis and to describe their hemoglobin concentration around the 6th month of treatment with Mircera®.

Secondary objective:
In the total population and in each sub-population of patients (hemodialysis and peritoneal dialysis, ESA-naive and non ESA-naive patients):
1. Describe the characteristics of patients treated with Mircera®;
2. Describe the evolution of Hb and hematocrit levels during the observation period;
3. Describe the biological parameters used to document renal anemia and any changes in values;
4. Describe the parameters influencing treatment response;
5. Describe the biological parameters reflecting the efficacy of dialysis;
6. Describe the safety profile of Mircera® (serious and/or unexpected adverse drug reactions and targeted adverse drug reactions related to Mircera®);
7. Describe treatment compliance with Mircera®;
8. Describe the evolution of patients’ quality of life, evaluated by the SF-36 questionnaire.
Inclusion criteria Inclusion criteria:
- Adult (aged >= 18 years);
- With CKD and on dialysis for more than 3 months;
- ESA-naive or not;
- For whom the physician decided to initiate treatment with Mircera® for renal anemia at the inclusion visit;
- Who was informed about the study both orally and in writing and who did not object to their personal data being processed.

Exclusion criteria:
- Patient participating in a clinical study;
- Anemia due to a malignant disease.
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) 2010
Date of last collection (YYYY or MM/YYYY) 2011
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 414
Data
Database activity Data collection completed
Type of data collected Clinical data
Biological data
Clinical data (detail) Medical registration
Details of collected clinical data Patient provided with information about the study - Demographic and clinical data, concomitant diseases - History of chronic renal failure and dialysis - Previous treatment for CKD-associated anemia: with ESA if any and other potential treatments (iron, folic acid, vitamin B12, blood transfusion over the last 3 months before Mircera® initiation) - Clinical data at the midweek dialysis session: weight after the session, blood pressure at rest and after the session - Most recent available laboratory data: urea and serum creatinine (before and after the dialysis session), urea reduction ratio, Kt/V (hemodialysis), total Kt/V (peritoneal dialysis), Hb, hematocrit, platelet count, reticulocytes, iron status, C-reactive protein, documented deficiency in folic acid or vitamin B12 if any - Treatment of CKD-associated anemia at inclusion: treatment with Mircera® and concomitant treatment if any (iron, folic acid, vitamin B12) - Other treatments: antihypertensives, antiplatelet drugs, anticoagulants, LMWH, lipid-lowering treatments, antidiabetics, immunosuppressors.
Presence of a biobank No
Health parameters studied Health care consumption and services
Care consumption (detail) Medicines consumption
Procedures
Data collection method paper
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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