CKD-REIN

SOME ANSWERS TO YOUR QUESTIONS

• 1- What are the objectives of the CKD-REIN cohort?

  The data collected since 2013 allow us to tackle the following objectives:

  • To study determinants and biomarkers associated with prognosis and complications of the disease
  • To identify healthcare practices related to better preservation of kidney function, fewer hospitalizations, and smoother transition to dialysis when needed
  • To understand what matters most in chronic kidney disease from the patients' perspective

  The CKD-REIN study aims to identify therapeutic targets, clinical practices, and more effective models of healthcare organization that could help guide health authorities in developing healthcare strategies for people with chronic kidney disease.

• 2- How is data collection progressing?

  Launched in July 2013, CKD-REIN is organized around three main data collection phases:

  During the first phase, our clinical research associates collected data about your health from your medical records, your nephrologist, and during annual interviews conducted face-to-face or by phone. Each year, you were also asked to complete self-administered questionnaires sent to your home. With your consent, blood and urine samples were collected thrice throughout the follow-up. Intended for the discovery of innovative biomarkers, these samples are now stored in a biobank. Finally, data about you were collected from the following French medico-administrative databases:

  • The National Health Data System (SNDS), managed by the French Health Insurance
  • The national Renal Epidemiology and Information Network (REIN) registry of dialysis and kidney transplantation, managed by the Agency of Biomedicine
  • The national register of identification of physical persons (RNIPP), managed by INSEE

  This first phase of data collection ended in December 2020.

  The second data collection phase took place between 2021 and 2022, eight years after your inclusion in the study. You were contacted again to complete a self-administered questionnaire.

  We inform you that you will no longer be contacted directly by the cohort personnel.

  However, with the authorization of the CNIL (French data protection authority), we will continue, until the end of 2026, to collect information about you through the aforementioned French medico-administrative databases, as part of the third phase of data collection.

  For a list of the data collected, please refer to paragraph 3.

• 3- What ongoing projects are being conducted?

  In practice, when a research project that aligns with one of the cohort’s objectives is approved by the Steering Committee:

  • The CKD-REIN team securely transfers, to the researcher only, the data strictly necessary to carry out the project. This transfer is preceded by mandatory legal and regulatory procedures; a specific information note accompanies the data provision (see the “Ongoing Projects” tab).
  • Your data are always handled with strict confidentiality. The researcher analyzing the data cannot access your identity.
  • All results from studies conducted within CKD-REIN are, with few exceptions, intended to be made public (in the form of publications in scientific journals or reports). You can follow the progress of CKD-REIN and its results on this website under the “Publications” tab.

  You can consult the list of ongoing projects under the “Ongoing Projects” tab. This list is regularly updated. For each research project, the scientific lead’s name, affiliation, study objectives, data used, and data recipient are specified.

  Further details about data governance and the conditions for data access for researchers can be found respectively under the “Overview” and “Data” tabs.

• 4- Which data are collected?

  Identity data:
  Civil status (full date of birth, family name, maiden name, first names, sex, place of birth), residential address.

  Health data:
  Medical history and clinical risk factors at inclusion, parents’ country of birth to determine geographic origin, medical consultations and procedures, history of kidney disease, kidney ultrasound, hospitalizations and interventions, biological tests, medical imaging, transfusions, vaccinations, medications, clinical and anthropometric measurements such as height, weight, and blood pressure, cognitive testing, management of chronic kidney disease, preparation for renal replacement therapy, dialysis access type, women’s reproductive health, sleep questionnaire.

  Socio-professional data:
  Marital status, household composition, number of children, living environment, socio-professional category, education level, employment status, income bracket, past and present professional career.

  Behavioral data:
  Tobacco and alcohol consumption, physical activity questionnaire.

  Quality of life data:
  Quality of life questionnaires, psychometric scales, activities of daily living, relationships with family and social environment, satisfaction with care.

  Dietary data:
  Consumption of fruits, vegetables, cereals, sugar, meat, fish, dairy products, etc.

  Biological and molecular data:
  Biological and genetic markers established from samples stored in the biobank.

  Vital status

  Kidney health data:
  Date and location of dialysis and/or kidney transplantation.

  National Health Data System (SNDS):
  Health care expenses and reimbursements (outpatient care, hospital care, and associated amounts), including outpatient care consumption (consultations, technical acts, etc.), prescriptions for medications and medical devices, transportation, hospital stays and diagnoses; daily allowances and disability benefits; long-term illnesses (ALD); health coverage; information on date and medical causes of death; treating physician and other health professionals.

• 5- How long will my data be kept?

  As part of this research, your data have been made available to the project leader, the CESP INSERM U1018, France. This provision is necessary for the statistical analyses carried out by the team.

  Since 2024, the data have been stored in the information system of the INSERM Joint Service Unit (UMS) "France Cohortes." The cohort is linked to the SNDS, and the data resulting from this linkage (except for your identity data) are hosted at the CASD, in accordance with CNIL authorization and the agreement established with the French National Health Insurance Fund.

  To fulfill the study’s objectives and make the best use of the information collected in the CKD-REIN cohort, the processing of your data will end in 2041, that is, up to 15 years after the end of data collection, which will last until the end of 2026.

  For research projects requiring data transfer to another recipient, your data undergo specific processing (anonymization/pseudonymization, coding). All necessary authorizations from the competent authorities will be obtained prior to such data transfer. At the end of these research projects, the data will be retained for processing up to two years after the last publication of results or, if no publication occurs, until the signing of the final research report.

• 6- Under what conditions are my data processed and stored?

  All data collected from participants, except for SNDS data, have been stored in the France Cohortes infrastructure. This infrastructure is certified as an HDS (Health Data Host), ensuring traceability of access and processing, data confidentiality, and integrity. For more information about the security conditions at France Cohortes, please visit the dedicated page.

  To protect your identity and guarantee the confidentiality of your data, your identity data are stored separately from your other personal data within the France Cohortes infrastructure. They are never directly linked to your health data. However, they are retained to allow trusted third parties, authorized by CNIL, to periodically collect your medico-administrative data (see paragraph 2).

  Your data from the National Health Data System (SNDS) and those collected within the CKD-REIN cohort, except for your identity data, have been deposited in the CASD (Secure Data Access Center) infrastructure. This public infrastructure meets the highest current standards for data confidentiality and security. For more information about their certifications, please visit their website and the project page.

• 7- What are my rights?

  In accordance with the General Data Protection Regulation (Regulation (EU) 2016/679) and the French Data Protection Act (Law No. 78-17), you have the following rights:

  • Right of access: You have the right to access information concerning you, to verify its accuracy and, if necessary, to rectify, complete, or update it.
  • Right to object: You may object at any time to the transmission of your data and request that your data no longer be collected for the future. Exercising this right will result in the termination of your participation in the study.
  • Right to restrict processing: You have the right to temporarily block the use of your data; no operation can be performed on it during this period.

  Please note, however, that data collected prior to the exercise of your right to object or withdrawal of consent may continue to be processed confidentially to avoid compromising the research objectives.

  If you wish to exercise these rights and obtain access to information concerning you, please contact Dr. Natalia Alencar de Pinho, the cohort’s coordinating investigator, by email (natalia.alencar-de-pinho@inserm.fr) or by mail (Inserm U1018 CESP, Hôpital Paul Brousse Bâtiment 15/16, 16 Avenue Paul Vaillant Couturier, 94807 Villejuif CEDEX, France).

  If you experience any difficulty in exercising your rights, you may also contact our Data Protection Officer by email (dpo@inserm.fr) or by mail (Data Protection Officer, Inserm, 101 rue de Tolbiac, 75013 Paris, France).

  You also have the right to file a complaint with the French Data Protection Authority (CNIL) at 3 Place de Fontenoy - TSA 80715, 75334 PARIS CEDEX 07, or online at https://www.cnil.fr.

  Unless you object, part of your data and/or biological samples may be reused secondarily within research partnerships and transferred to other public or private organizations or institutions, in France or abroad. In the event of transfer of your pseudonymized data, you will be informed of the conditions of this transfer on the France Cohortes website at least 4 to 6 weeks prior to the transfer. The GDPR requires that any transfer of your pseudonymized data to a third country be governed by appropriate and suitable safeguards set out in a contract or data-sharing agreement between Inserm and the data recipients, ensuring the confidentiality of your data.