Clinical trial NCT05395247: Geriatric Assessment for Older Kidney Transplantation Candidates
Official title: Evaluation gériatrique Avant Transplantation rénale
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Keywords: chronic kidney disease
kidney transplantation
comprehensive geriatric assessment
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease stages 4-5 treated or not by dialysis or kidney transplantation

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inscription on kidney transplantation waiting list
timeFrame: 6 months
Secondary outcomes:
measure: Length of hospitalization in the year following kidney transplantation
timeFrame: 1 year after kidney transplantation
measure: Delayed renal recovery following kidney transplantation
timeFrame: 1 week after kidney transplantation
measure: Mortality
timeFrame: 1 year after kidney transplantation
Other outcomes:
measure: Evolution of quality of life while on waiting list and after kidney transplantation
timeFrame: 1 year after kidney transplantation
measure: Evolution of cognitive functions while on waiting list and after kidney transplantation
timeFrame: 1 year after kidney transplantation
measure: Evolution of executive functions while on waiting list and after kidney transplantation
timeFrame: 1 year after kidney transplantation
measure: Evolution of mood while on waiting list and after kidney transplantation
timeFrame: 1 year after kidney transplantation
measure: Evolution of frailty while on waiting list and after kidney transplantation
timeFrame: 1 year after kidney transplantation
measure: Evolution of functionnal status while on waiting list and after kidney transplantation
timeFrame: 1 year after kidney transplantation
measure: Evolution of functionnal status while on waiting list and after kidney transplantation
timeFrame: 1 year after kidney transplantation
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
affiliation: Department of Geriatrics, Caen University Hospital, Caen, France
name: Cédric Villain, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: