Geriatric Assessment for Older Kidney Transplantation Candidates

Evaluation gériatrique Avant Transplantation rénale

Geriatric assessment is now widely used to decide whether older patients with chronic kidney disease should be put on the kidney transplantation waiting list. This study aims to evaluate the association between Geriatric assessment and inscription on kidney transplantation.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Other: Geriatric assessment

Detailed Description

There is a high proportion of older patients among patients with kidney failure, raising the question of the access to kidney transplantation within these patients. Geriatric assessment is now widely used to decide whether older patients with chronic kidney disease should be put on the kidney transplantation waiting list.

This study aims to evaluate the association between Geriatric assessment and inscription on kidney transplantation. Secondary objectives includes the analysis of the association between Geriatric assessment and:

• post-kidney transplantation outcomes
• quality of life.

It also includes the evolution of Geriatric assessment while still on waiting list and after kidney transplantation.

This study takes place in an University Hospital in Caen, France. This hospital is the only one performing kidney transplantation in the three French departments around. Candidates for kidney transplantation older than 70 years are systematically evaluated by a trained nurse and a geriatrician to perform a comprehensive geriatric assessment, evaluating cognitive functions, risk of fall, nutrition, frailty, functional status, and depressive symptoms. These patients are followed-up each year while still on the waiting list, and once after kidney transplantation. All patients evaluated within this consultation are proposed to enter the study. Patients are excluded in case of refusal or if they are unable to provide informed consent. The inclusion began in January 2019.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Cédric Villain, MD, PhD; Phone Number: +33 2 31 06 30 51; Email: villain-c@chu-caen.fr

Study Locations

• France
  • Caen, France, 14033
    • Recruiting
    • CAEN University Hospital
    • Contact: Cédric Villain, MD, PhD; Phone Number: +33231063051; Email: villain-c@chu-caen.fr
    • Principal Investigator: Cédric Villain, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic kidney disease stages 4-5 treated or not by dialysis or kidney transplantation

Description

Inclusion Criteria:

• All patients addressed for Geriatric assessment before inscription on kidney transplantation waiting list in Caen University Hospital, France

Exclusion Criteria:

• Patient refusal
• Patient unable to provide informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inscription on kidney transplantation waiting list	Inscription on kidney transplantation waiting list	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospitalization in the year following kidney transplantation	Units: days	1 year after kidney transplantation
Delayed renal recovery following kidney transplantation	Dialysis requirement during the first week after kidney transplantation	1 week after kidney transplantation
Mortality	Death in the year following kidney transplantation	1 year after kidney transplantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of quality of life while on waiting list and after kidney transplantation	Assessed by the SF12 score before and in the year after kidney transplantation	1 year after kidney transplantation
Evolution of cognitive functions while on waiting list and after kidney transplantation	Cognitive functions assessed by MMSE score	1 year after kidney transplantation
Evolution of executive functions while on waiting list and after kidney transplantation	Executive functions assessed by BREF test	1 year after kidney transplantation
Evolution of mood while on waiting list and after kidney transplantation	Mood assessed by the mini GDS scale	1 year after kidney transplantation
Evolution of frailty while on waiting list and after kidney transplantation	Frailty assessed by the Rockwood scale	1 year after kidney transplantation
Evolution of functionnal status while on waiting list and after kidney transplantation	Functionnal status assessed by activities of daily living scales	1 year after kidney transplantation
Evolution of functionnal status while on waiting list and after kidney transplantation	Functionnal status assessed by the walk speed in m/s	1 year after kidney transplantation

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Cédric Villain, MD, PhD, Department of Geriatrics, Caen University Hospital, Caen, France

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: chronic kidney disease; kidney transplantation; comprehensive geriatric assessment
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 1154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data would be available on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No