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

Kidney Function Issue Clinical Trial

— EPSER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06219798
• Other study ID #: Pathway CKD 4 and 5
• Status: Recruiting
• Start date: April 9, 2024
• Est. completion date: June 7, 2024

Study information

• Verified date: May 2024
• Source: Association d' Utilisation du Rein Artificiel SANTE
• Contact: Hélène PAGES
• Phone: 07 56 05 21 24
• Email: h.pages[@]aurasante.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 7, 2024
• Est. primary completion date: May 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Function Issue
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• GFR
Exit of the study due to death, dialysis, or transplantation

Locations

Country	Name	City	State
France	Aura Sante	Chamalières	Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
Association d' Utilisation du Rein Artificiel SANTE

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patients survival rate	Number of deaths during the sudy period	Every 6 months for 24 months
Secondary	Renal survival rate	Number of patients initiating dialysis during the study period	Every 6 months for 24 months
Secondary	Haemoglobin levels	Evolution of haemoglobin levels during the study period in gram/dL	Every 6 months for 24 months
Secondary	Plasma Calcium levels	Evolution of plasma calcium levels during the study period in mg/dL	Every 6 months for 24 months
Secondary	Plasma Phosphate levels	Evolution of plasma phosphate levels during the study period in mg/dL	Every 6 months for 24 months
Secondary	Plasma parathyroid hormone levels	Evolution of plasma parathyroid hormone levels during the study period in pg/ml	Every 6 months for 24 months
Secondary	Plasma alcaline reserve levels	Evolution of plasma alcaline reserve levels during the study period in mmol/l	Every 6 months for 24 months
Secondary	24h salt consumption	Evolution of salt consumption during the study period in g/24h	Every 6 months for 24 months
Secondary	24h protein consumption	Evolution of protein consumption during the study period in g/24h	Every 6 months for 24 months
Secondary	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