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NCT06825234 | NOT YET RECRUITING | Chronic Kidney Disease Stage 5

Prognostic Value of a Multidimensional Assessment for Survival in Elderly Patients With CKD 4B/5
Sponsor:

Besancon University Hospital Center

Brief Summary:

The aim of this study is to determine a multidimensional signature (integrating frailty and patient-reported outcomes measures (PROMs) at entry into stage 4B/5 CKD) to improve prediction of renal death (dialysis, transplantation, conservative management, death).

Condition or disease

Chronic Kidney Disease Stage 5

Chronic Kidney Disease Stage 4B

Detailed Description:

In 2019, 4,263 patients starting dialysis in France were aged 75 years or older. This elderly population, often with comorbidities, poses a number of challenges for nephrologists, both in terms of initiation and modalities of dialysis and access to transplantation. Dialysis may offer little benefit in terms of survival, often at the cost of a significant impact on quality of life and number of hospitalisations. There is a current trend to offer conservative treatment as an alternative to dialysis. However, there are no objective criteria to guide this decision and the uremic syndrome may distort certain clinical perceptions. The aim of this study is to determine whether an assessment that incorporates multiple dimensions, including those of frailty, can help the clinician determine the best course of treatment for the patient.

Study Type : OBSERVATIONAL
Estimated Enrollment : 390 participants
Official Title : Prognostic Value of a Multidimensional Assessment for Survival in Elderly Patients With CKD 4B/5
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2028-12
Estimated Study Completion Date : 2028-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patients with CKD stage 4B or 5 (first consultation with GFR \< 20 mL/min /1.73 m2 in CKD-EPI 2009).
  • * Fluency in French
  • * Membership of a French social security scheme
  • * Non-opposition from the subject to participate in the study
Exclusion Criteria
  • * Subjects with limited legal capacity.
  • * Subjects still in the exclusion period of another study, or according to the national registry of clinical trial participants.
  • * Subjects with no social security coverage.
  • * Subjects judged by the investigator to be unlikely to comply with study procedures
  • * Subjects unable to understand the reasons for the study; psychiatric disorders judged by the investigator to be incompatible with inclusion in the study.
Prognostic Value of a Multidimensional Assessment for Survival in Elderly Patients With CKD 4B/5

Location Details

NCT06825234

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

France,

Besançon University Hospital

Besançon, France, 25000

Not yet recruiting

France,

Tours University Hospital

Tours, France, 37044