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

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Function Issue
• Intervention / Treatment: Diagnostic test: GFR

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Hélène PAGES; Phone Number: 07 56 05 21 24; Email: h.pages@aurasante.com

Study Locations

• France
  • Auvergne
    • Chamalières, Auvergne, France, 63400
      • Recruiting
      • AURA Santé
      • Contact: Hélène PAGES; Phone Number: 0667517741; Email: pages.ln43@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Name of Arm 1: Study group; Description: Full participation (medical + dietitian+ specialist nurse)	Diagnostic test: GFR; Exit of the study due to death, dialysis, or transplantation; Other Names: Renal outcome
Name of Arm 2: Control 1; Description: Partial participation (medical+ dietitian OR specialist nurse)	Diagnostic test: GFR; Exit of the study due to death, dialysis, or transplantation; Other Names: Renal outcome
Name of Arm 3: Control 2; Description: No participation (medical visit only)	Diagnostic test: GFR; Exit of the study due to death, dialysis, or transplantation; Other Names: Renal outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Every 6 months for 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients survival rate	Number of deaths during the sudy period	Every 6 months for 24 months
Renal survival rate	Number of patients initiating dialysis during the study period	Every 6 months for 24 months
Haemoglobin levels	Evolution of haemoglobin levels during the study period in gram/dL	Every 6 months for 24 months
Plasma Calcium levels	Evolution of plasma calcium levels during the study period in mg/dL	Every 6 months for 24 months
Plasma Phosphate levels	Evolution of plasma phosphate levels during the study period in mg/dL	Every 6 months for 24 months
Plasma parathyroid hormone levels	Evolution of plasma parathyroid hormone levels during the study period in pg/ml	Every 6 months for 24 months
Plasma alcaline reserve levels	Evolution of plasma alcaline reserve levels during the study period in mmol/l	Every 6 months for 24 months
24h salt consumption	Evolution of salt consumption during the study period in g/24h	Every 6 months for 24 months
24h protein consumption	Evolution of protein consumption during the study period in g/24h	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	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Association d' Utilisation du Rein Artificiel SANTE

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Actual): May 22, 2024
• Study Completion (Estimated): June 7, 2024

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: Pathway CKD 4 and 5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The chief investigator is going solely to include and analyse data without sharing them with anybody else

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No