Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 2:08 PM
Study NCT ID:
NCT06825234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-01
First Post:
2025-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Value of a Multidimensional Assessment for Survival in Elderly Patients With CKD 4B/5
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Study Overview
Official Title:
Prognostic Value of a Multidimensional Assessment for Survival in Elderly Patients With CKD 4B/5
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROFILER
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: