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NCT Number: NCT06825234

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Charline Vauchy, PhD.

CONTACT

[email protected]

+33381218875

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: PROFILER

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 13, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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