Chronic Kidney Disease - REAL Life Study in Alsace

Chronic Kidney Diseases Clinical Trial

— CKD-REAL  

Official title:

Chronic Kidney Disease - REAL Life Study in Alsace

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05527626
• Other study ID #: 8517
• Status: Recruiting
• Start date: February 17, 2022
• Est. completion date: August 1, 2027

Study information

• Verified date: November 2023
• Source: University Hospital, Strasbourg, France
• Contact: Peggy PERRIN, MD
• Phone: 33 3 69 55 13 26
• Email: peggy.perrin[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: August 1, 2027
• Est. primary completion date: August 1, 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
France	Service Néphrologie-Dialyse-Transplantation - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retroanalysis of the risk factors in patients with severe chronic kidney disease	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