Chronic Kidney DiseasesNCT05395247
Geriatric Assessment for Older Kidney Transplantation Candidates
An observational study of Chronic Kidney Diseases, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Geriatric assessment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
Study population: Patients with chronic kidney disease stages 4-5 treated or not by dialysis or kidney transplantation
Who may be able to join
- All patients addressed for Geriatric assessment before inscription on kidney transplantation waiting list in Caen University Hospital, France
Who cannot join
- Patient refusal
- Patient unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, 14033
Cédric Villain, MD, PhD, +33231063051, villain-c@chu-caen.fr
Cédric Villain, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Geriatric assessment
- Keywords
- chronic kidney disease, kidney transplantation, comprehensive geriatric assessment
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric assessmentOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Inscription on kidney transplantation waiting list
Inscription on kidney transplantation waiting list
Measured: 6 months
Secondary outcomes (3)
Length of hospitalization in the year following kidney transplantation
Units: days
Measured: 1 year after kidney transplantation
Delayed renal recovery following kidney transplantation
Dialysis requirement during the first week after kidney transplantation
Measured: 1 week after kidney transplantation
Mortality
Death in the year following kidney transplantation
Measured: 1 year after kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Jan 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cédric VILLAIN, University Hospital, Caen
- Investigators
- Cédric Villain, MD, PhD, Principal investigator, Department of Geriatrics, Caen University Hospital, Caen, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395247
- Sponsor's protocol ID
- 1154
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data would be available on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation gériatrique Avant Transplantation rénale
- ClinicalTrials.gov ID
- NCT05395247
- Acronym / sponsor ID
- 1154
- Conditions
- Chronic Kidney Diseases
- Keywords
- chronic kidney disease, kidney transplantation, comprehensive geriatric assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients with chronic kidney disease stages 4-5 treated or not by dialysis or kidney transplantation
Key inclusion criteria (1 listed)
- All patients addressed for Geriatric assessment before inscription on kidney transplantation waiting list in Caen University Hospital, France
Key exclusion criteria (2 listed)
- Patient refusal
- Patient unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric assessmentGeriatric 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. | Other | – |
Primary outcome
Inscription on kidney transplantation waiting list
Time frame: 6 months
Inscription on kidney transplantation waiting list
3 secondary outcomes
Length of hospitalization in the year following kidney transplantation
Time frame: 1 year after kidney transplantation
Delayed renal recovery following kidney transplantation
Time frame: 1 week after kidney transplantation
Mortality
Time frame: 1 year after kidney transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: Undecided. Data would be available on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cédric Villain, MD, PhD principal investigator
Department of Geriatrics, Caen University Hospital, Caen, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cédric Villain, MD, PhD (+33 2 31 06 30 51, villain-c@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inscription on kidney transplantation waiting list (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.