Chronic Kidney Disease stage4NCT06495385
Evaluation of a Multidisciplinary Care Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease
An observational study of Chronic Kidney Disease stage4 and Chronic Kidney Disease Stage 5, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The number of incident and prevalent patients with end stage renal disease on dialysis treatment is increasing in France and worldwide. A quarter of dialysis patients are initiating dialysis urgently through central venous catheters and the number of patients registered in the waiting list for renal transplantation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5
- What is being tested?
- Evolution of renal function, Measurement of haemoglobin levels and Measurement of biological parameters
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 535 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2024to Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced chronic kidney disease will be included.
Who may be able to join
- All stage 4 and 5 Chronic Kidney Disease patients that were included in the program from 01/01/2021 to 31/12/2021 in the clinics of AURA SANTE
Who cannot join
- Patients without a medical follow up during this year (2021)
- Patients with insufficient or no data during the 24 month of follow up period
- Active treatment with corticosteroids, cytotoxic or immunosuppressive drugs, ongoing infection, autoimmune disease or active tumor process.
Trial locations and contacts
1 site in 1 country.
About this study
The number of incident and prevalent patients with end stage renal disease on dialysis treatment is increasing in France and worldwide. A quarter of dialysis patients are initiating dialysis urgently through central venous catheters and the number of patients registered in the waiting list for renal transplantation before dialysis initiation is very low. This is also reflected in the very low number of pre-emptive renal transplantations.
In order to reduce the number of dialysis patients, the French state has induced a national program proposing a multidisciplinary care pathway including the nephrology visits and at least one consultation with a dietitian and a specialist renal nurse in all patients with Chronic Kidney Disease stage 4 and 5.
Read the detailed description
The aim of this single-center retrospective study is to evaluate the influence of the complete, partial or no participation in this program on the evolution of renal function and clinicobiological parameters in this group of patients.
- Being tested
- Evolution of renal function, Measurement of haemoglobin levels, Measurement of biological parameters, Measure sodium and protein consumption, Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)
- Keywords
- Multidisciplinary Care, Pathway, Chronic Kidney disease, Patients' education
- 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.
Evolution of renal functionDiagnostic test
Plasma creatinine levels and glomerular filtration rate estimated using the CKD-Epi formula adjusted for 1.73 m2 body surface area will be measured.
Measurement of haemoglobin levelsDiagnostic test
Haemoglobin levels will be measured.
Measurement of biological parametersDiagnostic test
Plasma levels of urea, calcium, phosphorus and parathyroid hormone, as well as alkaline reserve, will be measured.
Measure sodium and protein consumptionDiagnostic test
24-hour urine volume, proteinuria, urea and sodium, will be measured.
Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)Behavioural
The descriptive system comprises five dimensions: mobility, personal care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, mild problems, moderate problems, severe problems and extreme problems. The figures for the five dimensions can be combined into a 5-digit number describing the patient's state of health. Scores close to 1 indicate "the best health you can imagine" and those close to 0 "the worst health you can imagine".
| Study group | Role | What they receive |
|---|---|---|
| Study group | Full participation (medical + dietitian+ specialist nurse) Receives: Diagnostic Test: Evolution of renal function; Diagnostic Test: Measurement of haemoglobin levels; Diagnostic Test: Measurement of biological parameters; Diagnostic Test: Measure sodium and protein consumption; Behavioral: Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L) | |
| Control 1 | Partial participation (medical+ dietitian OR specialist nurse) Receives: Diagnostic Test: Evolution of renal function; Diagnostic Test: Measurement of haemoglobin levels; Diagnostic Test: Measurement of biological parameters; Diagnostic Test: Measure sodium and protein consumption; Behavioral: Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L) | |
| Control 2 | No participation (medical visit only) Receives: Diagnostic Test: Evolution of renal function; Diagnostic Test: Measurement of haemoglobin levels; Diagnostic Test: Measurement of biological parameters; Diagnostic Test: Measure sodium and protein consumption; Behavioral: Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of estimated Glomerular filtration rate with the CKD-EPI formula adjusted for 1.73m2 of body surface area for the three groups
The estimated Glomerular filtration rate is estimated with the CKD-EPI formula adjusted for 1.73m2 of body surface area and produced in ml/min/1.73m2 of body surface area. The CKD-EPI formula used is as follows: The conversion of serum creatinine level for the CKD-EPI formula was done as follows: creatinine level (mg/dl) = creatinine level (μmol/l) × 0.01131222 (considering that 1 mg/dl creatinine = 88.4 μmol/l creatinine). A GFR of 60 or more is within the normal range. A GFR below 60 may indicate kidney disease.
Measured: Month : 6, 12, 18 and 24
Secondary outcomes (11)
Evolution of renal survival over the follow up period for every group
Renal survival is measured as a percentage of remaining patients from baseline.
Measured: Month : 6, 12, 18 and 24
Evolution of patients' survival for every group during the study period
Patients survival is measured as a percentage of remaining patients from baseline.
Measured: Month : 6, 12, 18 and 24
Evolution of preemptive transplantation during the study period for the three study groups
The number of preventive transplants will be compared in each group.
Measured: Month : 6, 12, 18 and 24
Evolution of biological parameters : Haemoglobin
Haemoglobin levels are measured as gram/dL.
Measured: Month : 6, 12, 18 and 24
Evolution of biological parameters : plasma calcium
Plasma Calcium levels are measured as mg/dL.
Measured: Month : 6, 12, 18 and 24
Evolution of biological parameters : phosphate
Plasma Phosphate levels are measured as mg/dL.
Measured: Month : 6, 12, 18 and 24
Evolution of biological parameters : parathyroid hormone
Plasma parathyroid hormone levels are measured in pg/ml.
Measured: Month : 6, 12, 18 and 24
Evolution of biological parameters : alkaline reserve levels
Plasma alkaline reserve levels are measured in mmol/l.
Measured: Month : 6, 12, 18 and 24
Evolution of dietary parameters : salt consumption
24h salt consumption are measured in g/24h.
Measured: Month : 6, 12, 18 and 24
Evolution of dietary parameters : protein consumption
24h protein consumption are measured in g/24h.
Measured: Month : 6, 12, 18 and 24
Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)
The descriptive system comprises five dimensions: mobility, personal care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, mild problems, moderate problems, severe problems and extreme problems. The figures for the five dimensions can be combined into a 5-digit number describing the patient's state of health. Scores close to 1 indicate "the best health you can imagine" and those close to 0 "the worst health you can imagine".
Measured: Month : 6, 12, 18 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start9 Apr 2024
- Primary completion22 May 2024
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease stage4Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- 535 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène PAGES, nurse, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495385
- Sponsor's protocol ID
- IRBN1502023/CHUSTE
- Status last verified
- Jul 2024
- First submitted
- 26 Jan 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Multidisciplinary Care Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06495385
- Acronym / sponsor ID
- IRBN1502023/CHUSTE
- Keywords
- Multidisciplinary Care, Pathway, Chronic Kidney disease, Patients' education
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 535 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- Sep 2024 (estimated)
- First posted
- 10 Jul 2024 (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.
The number of incident and prevalent patients with end stage renal disease on dialysis treatment is increasing in France and worldwide. A quarter of dialysis patients are initiating dialysis urgently through central venous catheters and the number of patients registered in the waiting list for renal transplantation before dialysis initiation is very low. This is also reflected in the very low number of pre-emptive renal transplantations.
In order to reduce the number of dialysis patients, the French state has induced a national program proposing a multidisciplinary care pathway including the nephrology visits and at least one consultation with a dietitian and a specialist renal nurse in all patients with Chronic Kidney Disease stage 4 and 5.
Detailed description
The aim of this single-center retrospective study is to evaluate the influence of the complete, partial or no participation in this program on the evolution of renal function and clinicobiological parameters in this group of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Evolution of renal function, Diagnostic Test: Measurement of haemoglobin levels, Diagnostic Test: Measurement of biological parameters, Diagnostic Test: Measure sodium and protein consumption, Behavioral: Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)Full participation (medical + dietitian+ specialist nurse) |
| Control 1 | – | Diagnostic Test: Evolution of renal function, Diagnostic Test: Measurement of haemoglobin levels, Diagnostic Test: Measurement of biological parameters, Diagnostic Test: Measure sodium and protein consumption, Behavioral: Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)Partial participation (medical+ dietitian OR specialist nurse) |
| Control 2 | – | Diagnostic Test: Evolution of renal function, Diagnostic Test: Measurement of haemoglobin levels, Diagnostic Test: Measurement of biological parameters, Diagnostic Test: Measure sodium and protein consumption, Behavioral: Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)No participation (medical visit only) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced chronic kidney disease will be included.
Key inclusion criteria (1 listed)
- All stage 4 and 5 Chronic Kidney Disease patients that were included in the program from 01/01/2021 to 31/12/2021 in the clinics of AURA SANTE
Key exclusion criteria (3 listed)
- Patients without a medical follow up during this year (2021)
- Patients with insufficient or no data during the 24 month of follow up period
- Active treatment with corticosteroids, cytotoxic or immunosuppressive drugs, ongoing infection, autoimmune disease or active tumor process.
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 |
|---|---|---|
| Evolution of renal functionPlasma creatinine levels and glomerular filtration rate estimated using the CKD-Epi formula adjusted for 1.73 m2 body surface area will be measured. | Diagnostic test | Control 1, Control 2, Study group |
| Measurement of haemoglobin levelsHaemoglobin levels will be measured. | Diagnostic test | Control 1, Control 2, Study group |
| Measurement of biological parametersPlasma levels of urea, calcium, phosphorus and parathyroid hormone, as well as alkaline reserve, will be measured. | Diagnostic test | Control 1, Control 2, Study group |
| Measure sodium and protein consumption24-hour urine volume, proteinuria, urea and sodium, will be measured. | Diagnostic test | Control 1, Control 2, Study group |
| Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)The descriptive system comprises five dimensions: mobility, personal care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, mild problems, moderate problems, severe problems and extreme problems. The figures for the five dimensions can be combined into a 5-digit number describing the patient's state of health. Scores close to 1 indicate "the best health you can imagine" and those close to 0 "the worst health you can imagine". | Behavioural | Control 1, Control 2, Study group |
Primary outcome
Evolution of estimated Glomerular filtration rate with the CKD-EPI formula adjusted for 1.73m2 of body surface area for the three groups
Time frame: Month : 6, 12, 18 and 24
The estimated Glomerular filtration rate is estimated with the CKD-EPI formula adjusted for 1.73m2 of body surface area and produced in ml/min/1.73m2 of body surface area. The CKD-EPI formula used is as follows: The conversion of serum creatinine level for the CKD-EPI formula was done as follows: creatinine level (mg/dl) = creatinine level (μmol/l) × 0.01131222 (considering that 1 mg/dl creatinine = 88.4 μmol/l creatinine). A GFR of 60 or more is within the normal range. A GFR below 60 may indicate kidney disease.
11 secondary outcomes
Evolution of renal survival over the follow up period for every group
Time frame: Month : 6, 12, 18 and 24
Evolution of patients' survival for every group during the study period
Time frame: Month : 6, 12, 18 and 24
Evolution of preemptive transplantation during the study period for the three study groups
Time frame: Month : 6, 12, 18 and 24
Evolution of biological parameters : Haemoglobin
Time frame: Month : 6, 12, 18 and 24
Evolution of biological parameters : plasma calcium
Time frame: Month : 6, 12, 18 and 24
Evolution of biological parameters : phosphate
Time frame: Month : 6, 12, 18 and 24
Evolution of biological parameters : parathyroid hormone
Time frame: Month : 6, 12, 18 and 24
Evolution of biological parameters : alkaline reserve levels
Time frame: Month : 6, 12, 18 and 24
Evolution of dietary parameters : salt consumption
Time frame: Month : 6, 12, 18 and 24
Evolution of dietary parameters : protein consumption
Time frame: Month : 6, 12, 18 and 24
Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)
Time frame: Month : 6, 12, 18 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Hélène PAGES, nurse principal investigator
CHU de Saint-Etienne
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 Disease stage4 and Chronic Kidney Disease Stage 5, run by Centre Hospitalier Universitaire de Saint Etienne 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 3 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 10 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of estimated Glomerular filtration rate with the CKD-EPI formula adjusted for 1.73m2 of body surface area for the three groups (time frame: Month : 6, 12, 18 and 24). 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 10 Jul 2024.