Clinical trial NCT06219798: Evaluation of a Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease
Official title: Evaluation of a Multidisciplinary Care Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Function Issue
Lead sponsor: Association d' Utilisation du Rein Artificiel SANTE
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Glomerular filtration rate
timeFrame: Every 6 months for 24 months
Secondary outcomes:
measure: Patients survival rate
timeFrame: Every 6 months for 24 months
measure: Renal survival rate
timeFrame: Every 6 months for 24 months
measure: Haemoglobin levels
timeFrame: Every 6 months for 24 months
measure: Plasma Calcium levels
timeFrame: Every 6 months for 24 months
measure: Plasma Phosphate levels
timeFrame: Every 6 months for 24 months
measure: Plasma parathyroid hormone levels
timeFrame: Every 6 months for 24 months
measure: Plasma alcaline reserve levels
timeFrame: Every 6 months for 24 months
measure: 24h salt consumption
timeFrame: Every 6 months for 24 months
measure: 24h protein consumption
timeFrame: Every 6 months for 24 months
measure: Quality of life score
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Chamalières
country: France
facility: Aura Sante
state: Auvergne
Study officials:
References: