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

NCT06825234 | Not Yet Recruiting

• 1 other identifier: 2024/912
• Study Type: observational
• Target: 390
• Locations: 1 country
• Sites: 2

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).

Conditions

Chronic Kidney Disease Stage 5; Chronic Kidney Disease Stage 4B

Keywords

Frailty; Patient-Related Outcomes; Personalised care

Outcome Measures

Primary Outcomes (1)

• Overall survival

  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.

  24 months

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population consisted of patients aged 75 years and older with stage 4B/5 chronic kidney disease (GFR\<20ml/min/1.73m²), who spoke French and were under the usual care of the nephrology units involved in the study.

You may qualify if:

• 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

You may not qualify if:

• Subjects with limited legal capacity.
• Subjects with no social security coverage.
• Subjects judged by the investigator to be unlikely to comply with study procedures

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (2)

Besançon University Hospital

Besançon, 25000, France

Location

Tours University Hospital

Tours, 37044, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Frailty

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Charline Vauchy, PhD.

CONTACT

+33381218875; cvauchy@chu-besancon.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 1, 2025

Record last verified: 2024-11

Locations

FR (2)