NCT05395247

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

6 years

First QC Date

February 8, 2022

Last Update Submit

February 7, 2024

Conditions

Keywords

chronic kidney diseasekidney transplantationcomprehensive geriatric assessment

Outcome Measures

Primary Outcomes (1)

  • Inscription on kidney transplantation waiting list

    Inscription on kidney transplantation waiting list

    6 months

Secondary Outcomes (3)

  • Length of hospitalization in the year following kidney transplantation

    1 year after kidney transplantation

  • Delayed renal recovery following kidney transplantation

    1 week after kidney transplantation

  • Mortality

    1 year after kidney transplantation

Other Outcomes (7)

  • Evolution of quality of life while on waiting list and after kidney transplantation

    1 year after kidney transplantation

  • Evolution of cognitive functions while on waiting list and after kidney transplantation

    1 year after kidney transplantation

  • Evolution of executive functions while on waiting list and after kidney transplantation

    1 year after kidney transplantation

  • +4 more other outcomes

Interventions

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.

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patient refusal
  • Patient unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, 14033, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth StatusDemographyPopulation CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Cédric Villain, MD, PhD

    Department of Geriatrics, Caen University Hospital, Caen, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cédric Villain, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 8, 2022

First Posted

May 27, 2022

Study Start

January 1, 2019

Primary Completion

December 31, 2024

Study Completion

January 1, 2025

Last Updated

February 8, 2024

Record last verified: 2024-02

Locations