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

April 30, 2025 updated by: Centre Hospitalier Universitaire de Besancon
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).

Study Overview

Status

Not yet recruiting

Conditions

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

Enrollment (Estimated)

390

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 Locations

  • France
      • Besançon, France, 25000
        • Besançon University Hospital
        • Contact:
          • Charline Vauchy, PhD
        • Principal Investigator:
          • Melchior Chabannes, MD.
      • Tours, France, 37044
        • Tours University Hospital
        • Principal Investigator:
          • Bénédicte Sautenet, Prof.

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

  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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.
24 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Besancon

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 (Estimated)

June 1, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

February 13, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/912

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.

Subscribe