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

Not yet recruiting

• Conditions: Chronic Kidney Disease Stage 5; Chronic Kidney Disease Stage 4B

• Registration Number: NCT06825234
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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).

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 Timeline

• Status Verified: 2024-11
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Study First Posted: 2025-02-13
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-01
• Study Start: 2025-06
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 390

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	24 months	Time between first visit (entry into stage 4B/5) and death from any cause. Living patients will be censored at the date of last news. Entry into CKD 4B/5 is defined as the first kidney disease follow-up visit for which the patient has an eGFR strictly below 20 ml/min/1.73m2.

Trial Locations

Locations (2)

Besançon University Hospital; 🇫🇷 Besançon, France

Tours University Hospital; 🇫🇷 Tours, France