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

NCT06219798 | Recruiting DMC

• 1 other identifier: Pathway CKD 4 and 5
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Function Issue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Patients survival rate

  Every 6 months for 24 months

• Renal survival rate

  Every 6 months for 24 months

• Haemoglobin levels

  Every 6 months for 24 months

• Plasma Calcium levels

  Every 6 months for 24 months

• Plasma Phosphate levels

  Every 6 months for 24 months

Study Arms (3)

Name of Arm 1: Study group

Description: Full participation (medical + dietitian+ specialist nurse)

Diagnostic Test: GFR

Name of Arm 2: Control 1

Description: Partial participation (medical+ dietitian OR specialist nurse)

Diagnostic Test: GFR

Name of Arm 3: Control 2

Description: No participation (medical visit only)

Diagnostic Test: GFR

Interventions

GFR DIAGNOSTIC_TEST

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

Also known as: Renal outcome

Name of Arm 1: Study group; Name of Arm 2: Control 1; Name of Arm 3: Control 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association d' Utilisation du Rein Artificiel SANTE: lead

Study Sites (1)

Aura Sante

Chamalières, Auvergne, 63400, France

RECRUITING

Central Study Contacts

Hélène PAGES

CONTACT

07 56 05 21 24; h.pages@aurasante.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: January 23, 2024
• Study Start: April 9, 2024
• Primary Completion: May 22, 2024
• Study Completion: June 7, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)