CKD-REIN - Chronic Kidney Disease - Renal Epidemiology and Information Network
Head :
STENGEL Bénédicte, Centre d'Epidémiologie et Santé des Populations, CESP, Equipe 5, Epidémiologie Clinique
Last update : 09/23/2020 | Version : 5 | ID : 3087
| General | |
| Identification | |
| Detailed name | Chronic Kidney Disease - Renal Epidemiology and Information Network |
| Sign or acronym | CKD-REIN |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCTIRS, no 12- 360; CNIL DR-2012-469; CPP Kremlin-Bicêtre, ID-RCB 2012-A00902-41; International Review Board de l’Inserm n°13-108; Codecoh AC-2012-1624 |
| General Aspects | |
| Medical area |
Urology, andrology and nephrology |
| Health determinants |
Genetic Lifestyle and behavior Medicine Nutrition Social and psychosocial factors |
| Keywords | organization of care and cost-effectiveness of practices, Dialysis, quality of life, biomarkers |
| Scientific investigator(s) (Contact) | |
| Name of the director | STENGEL |
| Surname | Bénédicte |
| Address |
CESP, Inserm U-1018 16 AVENUE PAUL VAILLANT COUTURIER , 94807 VILLEJUIF Cedex |
| Phone | (0)1 45 59 50 39 |
| benedicte.stengel@inserm.fr | |
| Unit | Centre d'Epidémiologie et Santé des Populations, CESP, Equipe 5, Epidémiologie Clinique |
| Organization | INSERM - Institut National de la Santé et de la Recherche Médicale; PARIS-SACLAY |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | The Chronic Kidney Disease Outcomes and Practice Patterns Study (CKDopps); ISN iNET-CKD (International Network of Chronic Kidney Disease cohort studies) |
| Funding | |
| Funding status |
Mixed |
| Details | CKD-REIN is supported by a public–private partnership with funding from seven pharmaceutical companies (ANR 2011 "Investissements d'avenir"; Amgen, Baxter, Fresenius 105 Medical Care, GlaxoSmithKline (GSK), Merck Sharp & Dohme- Chibret (MSD France) since 2012, Lilly France since 2013, Otsuka Pharmaceutical since 2015 and Sanofi-Genzyme from 2012 to 2015. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | PARIS-SUD UNIVERSITY |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Biomedicine Agency |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | NANCY UNIVERSITY HOSPITAL, PUBLIC HEALTH |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | LYON 3 UNIVERSITY, Economy |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | PICARDIE BIOBANK |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | CENTRE NATIONAL DE GENOTYPAGE |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | INSERM, I2MR, U858 |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | ARBOR RESEARCH |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | AMIENS UNIVERSITY HOSPITAL, Nephrology |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | BORDEAUX 2 UNIVERSITY HOSPITAL, Nephrology |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | LYON 1 UNIVERSITY HOSPITAL, Nephrology |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | NANCY UNIVERSITY HOSPITAL, Nephrology |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Etablissement Français du Sang |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Name of the contact | SPEYER |
| Surname | Elodie |
| Address |
CESP, Inserm U-1018 16 AVENUE PAUL VAILLANT COUTURIER , 94807 VILLEJUIF Cedex |
| Phone | (0)1 77 74 74 39 |
| elodie.speyer@inserm.fr | |
| Unit | Centre d'Epidémiologie et Santé des Populations, CESP, Equipe 5, Epidémiologie Clinique |
| Organization | INSERM - Institut National de la Santé et de la Recherche Médicale; PARIS-SACLAY |
| 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 carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | REIN administrative file of all nephrology care units classified by type and region will provide the source for selecting 10 nephrology clinics in each of the 5 inter-regions covered by 5 study co-coordinators. Participating clinics will be additionally required to care for at least 60 CKD patients Stage 3-5 per year. |
| Database objective | |
| Main objective |
The CKD-REIN cohort will provide a research platform to address key questions regarding a number of determinants and biomarkers associated with adverse CKD outcomes and to assess clinical practices and costs in patients selected at random from a representative sample of various types of nephrology consultations. In addition, it will meet the objectives of the starting international CKD Outcomes and Practice Patterns Study (CKDopps) designed principally to identify best treatment practices in patients with advanced CKD in several countries, including France.
The objectives of the CKD-REIN study are: (1) to study a set of social, environmental, behavioral, clinical, and genetic factors, and their interactions in relation with the outcomes of CKD and its complications, including progression to ESRD and mortality, as well as the onset of several relevant acute and chronic clinical events : acute kidney injury, infections; cardiovascular diseases, cognitive decline, bone disease, and cancer ; (2) to assess several new biomarkers to predict adverse outcomes of CKD and its complications; (3) to evaluate the associations of provider practices (management of hypertension and of CKD complications such as anemia, nutritional abnormalities, and bone mineral disorder; timing of dialysis initiation and transplant wait-listing) with achievement of clinical practice guidelines, clinical outcomes (survival, ESRD, hospital admissions) and patient-reported outcomes (QoL, satisfaction). (4) to evaluate the associations of health care organization (e.g., multidisciplinary team, care network) and clinic services (e.g., for nutrition, educational programs) with clinical and patient-reported outcomes, and achievement of clinical practice guidelines; (5) to estimate the relative cost-effectiveness of different provider practices and clinic services. (6) to estimate the CKD incidence and prevalence in nephrology healthcare practices in France, depending on age, sex, social status, diabetes status, and depending on the stage and type of CKD. |
| Inclusion criteria | Study eligibility requires an eGFR < 60 mL/min/1.73 m2 for at least one month and no prior dialysis or transplantation. Inclusion criteria also requires less than 3 years of follow-up by the nephrology clinic for patients with CKD stage 3 in order to reduce survival bias due to prevalent cases. Patients <18 yrs old, pregnant, institutionalized, or unable to give inform consent are excluded, as well as patients who decline to participate. |
| 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 |
| Detail of the geography area | Nationwide cohort study in France, part of which is a component of an international study: the Chronic Kidney Disease Outcomes and Practice Patterns Study (CKDopps) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2013 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 3033 patients |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | Demographics, cause of CKD. Medication categories: RAS antagonists, statins, phosphate binders, ESAs therapy. Nutrition: Prescribed restrictions of protein, potassium, sodium and phosphorus. RRT planning: Vascular access referral, placement & procedures, services used (education programs, social worker, dietician), timing of decision about RRT modality, transplant wait-listing. Dialysis data: eGFR at dialysis initiation, clinical measures & dialysis dose. Clinical outcomes: Hospitalizations (IS), death (TF), study departure. Clinical measures: Blood pressure, weight, height, urine protein, biochemical measures |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview Phone interview |
| Details of collected declarative data | Patient-reported data: Quality of life instruments (SF 12, KDQOL-SF™), Mental health (CES-D scale), activities of daily living, family relationships, Global Physical Activity Questionnaire (GPAQ), Sleep, diet, Social, and demographic characteristics, Medical expenses and health insurance, Physician contacts, dietary and social services, Kidney disease education and planning, Satisfaction with care, Women health, Occupational history, using validated instruments when possible. > Medical Director Survey: Clinic protocols for achieving practice guidelines. > Physician practices not covered by protocol: Preferences for levels to initiate therapy and target for blood pressure, hemoglobine, phosphate, proteinuria - Treatment preferences, use of single vs. dual RAS antagonists. > Surveys of other health care providers: Nutrition, social work, vascular access, ESRD education programs; staffing levels; integration of care (multidisciplinary care clinic); palliative care services |
| Biological data (detail) | Blood, urine, DNA, RNA samples |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Plasma Fluids (saliva, urine, amniotic fluid, …) DNA DNAc/RNAm |
| Details of biobank content | Fasting blood and second morning urine samples will be collected in all participants at enrolment and at study end, as well as at the 1- and 3-year follow-up in a subsample of 1200 patients. Serum, plasma, DNA and RNA will be stored at ultra-low temperature at the Biobanque de Picardie, |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Quality of life/perceived health (detail) | Quality of life instruments (SF 12, KDQOL-SF™), Mental health (CES-D scale), activities of daily living, family relationships, Global Physical Activity Questionnaire (GPAQ), Sleep |
| Procedures | |
| Data collection method | Data collection instruments include patient-level and provider-level questionnaires |
| Quality procedure(s) used | CKD-REIN biobank received a bio-collection authorization from the French Ministry of Research, CODECOH n° AC-2012-1624 based on the Picardie Biobank quality standard |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the participant (mail, e-mail, telephone etc.) Monitoring by crossing with a medical-administrative database Monitoring by crossing with a morbidity register |
| Details on monitoring of participants | Duration: 5 years |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | Linkage of CKD-REIN data to health insurance data is anticipated |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.hal.inserm.fr/CKD-REIN |
| Description | List of publications in HAL |
| Link to the document | https://pubmed.ncbi.nlm.nih.gov/?term=CKD-REIN |
| Description | List of publications in Pubmed |
| Link to the document | CKD-Rein.pdf |
| Access | |
| Dedicated website | https://ckdrein.inserm.fr/ |
| Presence of document that lists variables and coding procedures |
Yes |
| Terms of data access (charter for data provision, format of data, availability delay) |
Data collected about CKD patients, their sociodemographic characteristics, their environment and their treatments, the organization of health care system based on a representative sample of providers in the field of CKD, and the biobank will provide a unique research platform of major interest for a number of public and private organizations involved in the field of CKD research and patient care.
CKD-REIN will encourage innovative projects and broad use of these data by external research groups or firms. Accessibility of the database will be determined case by case by the governing board in agreement with the scientific committee. The IP and contractual issues will be examined by Inserm Transfert. Special attention will be paid on confidentiality, ethical issues and on the use of the biobank to yield the greatest scientific value to the community and avoid depletion of this finite resource. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
