Geriatric Assessment for Older Kidney Transplantation Candidates

Chronic Kidney Diseases Clinical Trial

Official title:

Evaluation gériatrique Avant Transplantation rénale

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05395247
• Other study ID #: 1154
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: University Hospital, Caen
• Contact: Cédric Villain, MD, PhD
• Phone: +33 2 31 06 30 51
• Email: villain-c[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 1, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Geriatric assessment
Geriatric assessment by a trained nurse and a geriatrician for older kidney transplantation candidates in Caen University Hospital. The geriatric assessment includes a evaluation of cognitive functions, depressive symptoms, risk of fall, nutrition, frailty, and functional status.

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Evolution of cognitive functions while on waiting list and after kidney transplantation	Cognitive functions assessed by MMSE score	1 year after kidney transplantation
Other	Evolution of executive functions while on waiting list and after kidney transplantation	Executive functions assessed by BREF test	1 year after kidney transplantation
Other	Evolution of mood while on waiting list and after kidney transplantation	Mood assessed by the mini GDS scale	1 year after kidney transplantation
Other	Evolution of frailty while on waiting list and after kidney transplantation	Frailty assessed by the Rockwood scale	1 year after kidney transplantation
Other	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
Other	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
Primary	Inscription on kidney transplantation waiting list	Inscription on kidney transplantation waiting list	6 months
Secondary	Length of hospitalization in the year following kidney transplantation	Units: days	1 year after kidney transplantation
Secondary	Delayed renal recovery following kidney transplantation	Dialysis requirement during the first week after kidney transplantation	1 week after kidney transplantation
Secondary	Mortality	Death in the year following kidney transplantation	1 year after kidney transplantation