Kidney Function IssueEPSERNCT06219798
Evaluation of a Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease
An observational study of Kidney Function Issue, run by Association d' Utilisation du Rein Artificiel SANTE 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
- Kidney Function Issue
- What is being tested?
- GFR
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2024to 7 Jun 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: 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 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.
France1 site, 1 recruiting
- Recruiting
Aura Sante
Chamalières, Auvergne, 63400
Hélène PAGES, 0667517741, pages.ln43@gmail.com
About this study
Official title: Evaluation of a Multidisciplinary Care Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease
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.
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.
- Conditions
- Kidney Function Issue
- Being tested
- GFR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFRDiagnostic test
Also called Renal outcome
Exit of the study due to death, dialysis, or transplantation
| Study group | Role | What they receive |
|---|---|---|
| Name of Arm 1: Study group | Description: Full participation (medical + dietitian+ specialist nurse) Receives: Diagnostic Test: GFR | |
| Name of Arm 2: Control 1 | Description: Partial participation (medical+ dietitian OR specialist nurse) Receives: Diagnostic Test: GFR | |
| Name of Arm 3: Control 2 | Description: No participation (medical visit only) Receives: Diagnostic Test: GFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate
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
Measured: Every 6 months for 24 months
Secondary outcomes (10)
Patients survival rate
Number of deaths during the sudy period
Measured: Every 6 months for 24 months
Renal survival rate
Number of patients initiating dialysis during the study period
Measured: Every 6 months for 24 months
Haemoglobin levels
Evolution of haemoglobin levels during the study period in gram/dL
Measured: Every 6 months for 24 months
Plasma Calcium levels
Evolution of plasma calcium levels during the study period in mg/dL
Measured: Every 6 months for 24 months
Plasma Phosphate levels
Evolution of plasma phosphate levels during the study period in mg/dL
Measured: Every 6 months for 24 months
Plasma parathyroid hormone levels
Evolution of plasma parathyroid hormone levels during the study period in pg/ml
Measured: Every 6 months for 24 months
Plasma alcaline reserve levels
Evolution of plasma alcaline reserve levels during the study period in mmol/l
Measured: Every 6 months for 24 months
24h salt consumption
Evolution of salt consumption during the study period in g/24h
Measured: Every 6 months for 24 months
24h protein consumption
Evolution of protein consumption during the study period in g/24h
Measured: Every 6 months for 24 months
Quality of life score
Scores from Evaluation Quality of life,5 dimensions, 5 levels (EQ-5D-5L), the higher the score the better the outcome
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start9 Apr 2024
- Primary completion22 May 2024
- Study completion7 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Function IssueStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association d' Utilisation du Rein Artificiel SANTE
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PAGES Helene, Association d' Utilisation du Rein Artificiel SANTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219798
- Sponsor's protocol ID
- Pathway CKD 4 and 5
- Acronym
- EPSER
- Status last verified
- May 2024
- First submitted
- 20 Nov 2023
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The chief investigator is going solely to include and analyse data without sharing them with anybody else
Publications
Pages H, Kosmadakis G, Kanouni FE, Necoara A, Baudenon J, Deville C, Enache I, Murat-Ringot A, Verot E. Evaluation of multidisciplinary care pathways on kidney function in patients with advanced chronic kidney disease: multicenter study. J Nephrol. 2025 Dec;38(9):2775-2784. doi: 10.1007/s40620-025-02365-8. Epub 2025 Oct 27.
PubMed 41145944
Study at a glance
From the registry record, last updated by the sponsor on 24 May 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
- NCT06219798
- Acronym / sponsor ID
- EPSER / Pathway CKD 4 and 5
- Conditions
- Kidney Function Issue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Association d' Utilisation du Rein Artificiel SANTEUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 7 Jun 2024 (estimated)
- First posted
- 23 Jan 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.
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
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Name of Arm 1: Study group | – | Diagnostic Test: GFRDescription: Full participation (medical + dietitian+ specialist nurse) |
| Name of Arm 2: Control 1 | – | Diagnostic Test: GFRDescription: Partial participation (medical+ dietitian OR specialist nurse) |
| Name of Arm 3: Control 2 | – | Diagnostic Test: GFRDescription: 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
- 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 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 |
|---|---|---|
| GFRAlso: Renal outcomeExit of the study due to death, dialysis, or transplantation | Diagnostic test | Name of Arm 1: Study group, Name of Arm 2: Control 1, Name of Arm 3: Control 2 |
Primary outcome
Glomerular filtration rate
Time frame: Every 6 months for 24 months
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
10 secondary outcomes
Patients survival rate
Time frame: Every 6 months for 24 months
Renal survival rate
Time frame: Every 6 months for 24 months
Haemoglobin levels
Time frame: Every 6 months for 24 months
Plasma Calcium levels
Time frame: Every 6 months for 24 months
Plasma Phosphate levels
Time frame: Every 6 months for 24 months
Plasma parathyroid hormone levels
Time frame: Every 6 months for 24 months
Plasma alcaline reserve levels
Time frame: Every 6 months for 24 months
24h salt consumption
Time frame: Every 6 months for 24 months
24h protein consumption
Time frame: Every 6 months for 24 months
Quality of life score
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Derived from this study: PubMed 41145944Pages H, Kosmadakis G, Kanouni FE, Necoara A, Baudenon J, Deville C, Enache I, Murat-Ringot A, Verot E. Evaluation of multidisciplinary care pathways on kidney function in patients with advanced chronic kidney disease: multicenter study. J Nephrol. 2025 Dec;38(9):2775-2784. doi: 10.1007/s40620-025-02365-8. Epub 2025 Oct 27.
- Individual participant dataSharing planned: No. The chief investigator is going solely to include and analyse data without sharing them with anybody else
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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.
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 Kidney Function Issue, run by Association d' Utilisation du Rein Artificiel SANTE 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 24 May 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 Hélène PAGES (07 56 05 21 24, h.pages@aurasante.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular filtration rate (time frame: Every 6 months for 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06219798, which also lists 1 linked publication.
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 24 May 2024.