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Evaluation of a Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease

Evaluation of a Multidisciplinary Care Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06219798
Acronym
EPSER
Enrollment
300
Registered
2024-01-23
Start date
2024-04-09
Completion date
2024-06-07
Last updated
2024-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Function Issue

Brief 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 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.

Interventions

DIAGNOSTIC_TESTGFR

Exit of the study due to death, dialysis, or transplantation

Sponsors

Association d' Utilisation du Rein Artificiel SANTE
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Glomerular filtration rateEvery 6 months for 24 monthsThe 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

Secondary

MeasureTime frameDescription
Renal survival rateEvery 6 months for 24 monthsNumber of patients initiating dialysis during the study period
Haemoglobin levelsEvery 6 months for 24 monthsEvolution of haemoglobin levels during the study period in gram/dL
Plasma Calcium levelsEvery 6 months for 24 monthsEvolution of plasma calcium levels during the study period in mg/dL
Plasma Phosphate levelsEvery 6 months for 24 monthsEvolution of plasma phosphate levels during the study period in mg/dL
Patients survival rateEvery 6 months for 24 monthsNumber of deaths during the sudy period
Plasma alcaline reserve levelsEvery 6 months for 24 monthsEvolution of plasma alcaline reserve levels during the study period in mmol/l
24h salt consumptionEvery 6 months for 24 monthsEvolution of salt consumption during the study period in g/24h
24h protein consumptionEvery 6 months for 24 monthsEvolution of protein consumption during the study period in g/24h
Quality of life scorethrough study completion, an average of 6 monthsScores from Evaluation Quality of life,5 dimensions, 5 levels (EQ-5D-5L), the higher the score the better the outcome
Plasma parathyroid hormone levelsEvery 6 months for 24 monthsEvolution of plasma parathyroid hormone levels during the study period in pg/ml

Countries

France

Contacts

Primary ContactHélène PAGES
h.pages@aurasante.com07 56 05 21 24

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026