Renal InsufficiencyBCDENCT00847275
Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
A study testing Exclusive nephrology follow-up and Geriatric follow-up in people with Renal Insufficiency, run by Nantes University Hospital at 1 site in France.
Trial summary
The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly patients aged over 75 years with renal insufficiency stage 5 will be included in the study after signed informed consent. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Exclusive nephrology follow-up and Geriatric follow-up
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2008to Jan 2015
- Phase
- Interventional
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged of 75 years old or more,
- Chronic kidney disease stage 5 defined by :
- either an estimated GFR (MDRD) ≤ 15ml/mn/1,73 m² in a non-dialysis patient whatever the duration of previous monitoring by the nephrologist("Pre-dialysis cohort"),
- or a dialysis treatment started for more than 3 months and less than one year, whatever the duration of pre-dialysis follow-up by the nephrologist("post-dialysis cohort"),
- Signed and dated informed consent.
Who cannot join
- Moderately severe to severe dementia (MMS ≤ 15),
- Major depression and/or GDS-15 > 10/15,
- Severe dependency (ADL < 3/6),
- Psychosis, mutism or aphasia,
- Malignancy or any pathology with life expectancy < one year,
- Ongoing specialized geriatric care
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes
Vincent ESNAULT, Profesor, 0492038876, esnault.v@chu-nice.fr
ESNAULT Vincent, Profesor
About this study
Official title: Behaviour and Cognitive Evaluation for Dialysis Elderly Patients
The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly patients aged over 75 years with renal insufficiency stage 5 will be included in the study after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in the "exclusive nephrology follow-up" arm will continue their usual follow-up; 250 patients in the "geriatric follow-up" arm will have both their usual nephrology follow-up and a geriatric follow-up.The aim of the study is to determine if a systematized gerontologist evaluation delay the occurrence of a composite primary endpoint : death, dementia, depression and severe dependency. The hypothesis is that the functional and vital prognosis of a patient with renal insufficiency depends not only on common and classical factors but also on cognitive and psychological functions and dependence, particularly in elderly patients.
- Conditions
- Renal Insufficiency
- Being tested
- Exclusive nephrology follow-up, Geriatric follow-up
- Keywords
- Elderly patients, renal insufficiency, gerontologic evaluation
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exclusive nephrology follow-upOther
250 patients will be included and randomized in the "exclusive nephrology follow-up" arm will continue their usual nephrology follow-up with consultations every 6 months during 3 years for dialysis patients or with consultations every 6 months before dialysis, 3 months after starting dialysis and every 6 months for a total duration of 3 years for non-dialysis patients. In addition to their nephrology consultations, patients will benefit from a geriatric evaluation with MMS, GDS and ADL scoring.
Geriatric follow-upOther
250 patients will be included and randomized in "geriatric follow-up" arm will continue their usual nephrology follow-up with consultations every 6 months during 3 years for dialysis patients or with consultations every 6 months before dialysis, 3 months after starting dialysis and every 6 months for a total duration of 3 years for non-dialysis patients. Patients randomized in the "geriatric follow-up" arm will also have more complete tests to evaluate cognitive functions (memory, language and movements), psychological functions (depression and anxiety) and dependency in activities of daily living. Other tests will allow evaluate vision, audition, mobility and nutritional status.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | "Exclusive nephrology follow-up" arm Receives: Other: Exclusive nephrology follow-up |
| 2 | Experimental | "Geriatric follow-up" arm Receives: Other: Geriatric follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
First outcome reached among: - death, - occurrence of a severe dementia (MMS < 10),- major depression detected by GDS-15 > 10/15 and confirmed by DSM-IV criteria,- severe dependency (ADL < 3/6).
Measured: 3 years
Secondary outcomes (1)
Secondary outcomes are: - cognitive, psychic and autonomy scores,- cardiovascular morbidity and mortality,- biological follow-up of chronic kidney disease including haemoglobin level.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startJul 2008
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Vincent ESNAULT, Profesor, Study chair, Centre Hospitalier Universitaire de NiceChristian COMBE, Profesor, Study chair, University Hospital, BordeauxMuriel RAINFRAY, Profesor, Study chair, University Hospital, BordeauxTugdual TANQUEREL, Doctor, Study chair, CHU BrestArmelle TILLY-GENTRIC, Profesor, Study chair, CHU de BrestMokhtar AMRANDI, Doctor, Study chair, CH CholetJacques d'AVIGNEAU, Doctor, Study chair, CH CholetPatrice DETEIX, Profesor, Study chair, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847275
- Sponsor's protocol ID
- 06/12-K
- Acronym
- BCDE
- Status last verified
- Jan 2010
- First submitted
- 17 Feb 2009
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behaviour and Cognitive Evaluation for Dialysis Elderly Patients
- ClinicalTrials.gov ID
- NCT00847275
- Acronym / sponsor ID
- BCDE / 06/12-K
- Conditions
- Renal Insufficiency
- Keywords
- Elderly patients, renal insufficiency, gerontologic evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 19 Feb 2009 (estimated)
- 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.
The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly patients aged over 75 years with renal insufficiency stage 5 will be included in the study after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in the "exclusive nephrology follow-up" arm will continue their usual follow-up; 250 patients in the "geriatric follow-up" arm will have both their usual nephrology follow-up and a geriatric follow-up.The aim of the study is to determine if a systematized gerontologist evaluation delay the occurrence of a composite primary endpoint : death, dementia, depression and severe dependency. The hypothesis is that the functional and vital prognosis of a patient with renal insufficiency depends not only on common and classical factors but also on cognitive and psychological functions and dependence, particularly in elderly patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: Exclusive nephrology follow-up"Exclusive nephrology follow-up" arm |
| 2 | Experimental | Other: Geriatric follow-up"Geriatric follow-up" arm |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients aged of 75 years old or more,
- Chronic kidney disease stage 5 defined by :
- either an estimated GFR (MDRD) ≤ 15ml/mn/1,73 m² in a non-dialysis patient whatever the duration of previous monitoring by the nephrologist("Pre-dialysis cohort"),
- or a dialysis treatment started for more than 3 months and less than one year, whatever the duration of pre-dialysis follow-up by the nephrologist("post-dialysis cohort"),
- Signed and dated informed consent.
Key exclusion criteria (6 listed)
- Moderately severe to severe dementia (MMS ≤ 15),
- Major depression and/or GDS-15 > 10/15,
- Severe dependency (ADL < 3/6),
- Psychosis, mutism or aphasia,
- Malignancy or any pathology with life expectancy < one year,
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 |
|---|---|---|
| Exclusive nephrology follow-up250 patients will be included and randomized in the "exclusive nephrology follow-up" arm will continue their usual nephrology follow-up with consultations every 6 months during 3 years for dialysis patients or with consultations every 6 months before dialysis, 3 months after starting dialysis and every 6 months for a total duration of 3 years for non-dialysis patients. In addition to their nephrology consultations, patients will benefit from a geriatric evaluation with MMS, GDS and ADL scoring. | Other | 1 |
| Geriatric follow-up250 patients will be included and randomized in "geriatric follow-up" arm will continue their usual nephrology follow-up with consultations every 6 months during 3 years for dialysis patients or with consultations every 6 months before dialysis, 3 months after starting dialysis and every 6 months for a total duration of 3 years for non-dialysis patients. Patients randomized in the "geriatric follow-up" arm will also have more complete tests to evaluate cognitive functions (memory, language and movements), psychological functions (depression and anxiety) and dependency in activities of daily living. Other tests will allow evaluate vision, audition, mobility and nutritional status. | Other | 2 |
Primary outcome
First outcome reached among: - death, - occurrence of a severe dementia (MMS < 10),- major depression detected by GDS-15 > 10/15 and confirmed by DSM-IV criteria,- severe dependency (ADL < 3/6).
Time frame: 3 years
1 secondary outcome
Secondary outcomes are: - cognitive, psychic and autonomy scores,- cardiovascular morbidity and mortality,- biological follow-up of chronic kidney disease including haemoglobin level.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2010.
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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.
Vincent ESNAULT, Profesor study chair
Centre Hospitalier Universitaire de Nice
Christian COMBE, Profesor study chair
University Hospital, Bordeaux
Muriel RAINFRAY, Profesor study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exclusive nephrology follow-up and Geriatric follow-up in people with Renal Insufficiency, run by Nantes University Hospital 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 5 inclusion and 6 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 26 Jan 2010. 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. Some participants in this study may receive a placebo. 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 Vincent ESNAULT, Profesor (0492038876, esnault.v@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First outcome reached among: - death, - occurrence of a severe dementia (MMS < 10),- major depression detected by GDS-15 > 10/15 and confirmed by DSM-IV criteria,- severe dependency (ADL < 3/6). (time frame: 3 years). 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 26 Jan 2010.