Chronic Kidney Disease - REAL Life Study in Alsace (CKD-REAL)

November 7, 2023 updated by: University Hospital, Strasbourg, France

Chronic kidney disease (CKD) is a public health problem and affects about 10% of the world's adult population with a constantly increasing incidence. The approach to CKD in France is centered on access to replacement therapy (dialysis, renal transplantation), the cost of which amounts to 4 billion euros (data from the REIN registry).

Real-life data are essential to specify the characteristics of patients with chronic kidney disease and the factors associated with the evolution of CKD and the occurrence of complications in order to improve the management of CKD before the suppletion stage.

Since October 2019, CKD at the severe stage (stage 4) and at the non-dialysis end stage (stage 5) is subject to an annual flat fee (Article L. 162-22-6-2 of the Social Security Code). The reimbursement of these lump sums by the health insurance is subject to the collection and transmission of certain medical data by the establishments.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service Néphrologie-Dialyse-Transplantation - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Peggy PERRIN, MD
        • Sub-Investigator:
          • Thierry Hannedouche, MD, PhD
        • Sub-Investigator:
          • Dorothée Bazin, MD
        • Sub-Investigator:
          • Thierry Krummel, MD
        • Sub-Investigator:
          • Marc Astrié, MD
        • Sub-Investigator:
          • Sophie Caillard, MD
        • Sub-Investigator:
          • Anne-Laure Faller, MD
        • Sub-Investigator:
          • Clotilde Muller, MD
        • Sub-Investigator:
          • François Chantrel, MD
        • Sub-Investigator:
          • Yves Dimitrov, MD
        • Sub-Investigator:
          • Alexandre Klein, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Major subject (≥18 years) with a chronic renal disease

Description

Inclusion criteria:

  • Major subject (≥18 years)
  • Subject included in the MRC package (GFR <30 ml/min/1.73 m2)
  • Subject who has not expressed opposition, after information, to the reuse of his or her data for the purpose of this research

Exclusion criteria:

- Subject having expressed his opposition to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retroanalysis of the risk factors in patients with severe chronic kidney disease
Time Frame: Files analysed retrospectively from October 01, 2019 to February 31, 2027 will be examined
Analysis of risk factors in patients with severe chronic kidney disease by retrospectively analyzing health data contained in patient medical records
Files analysed retrospectively from October 01, 2019 to February 31, 2027 will be examined

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Peggy PERRIN, MD, Service Néphrologie-Dialyse-Transplantation - CHU de Strasbourg - France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2022

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8517

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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