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Clinical Trials/NCT06219798
NCT06219798
Recruiting
Not Applicable

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

Association d' Utilisation du Rein Artificiel SANTE1 site in 1 country300 target enrollmentApril 9, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kidney Function Issue
Sponsor
Association d' Utilisation du Rein Artificiel SANTE
Enrollment
300
Locations
1
Primary Endpoint
Glomerular filtration rate
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 9, 2024
End Date
June 7, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Association d' Utilisation du Rein Artificiel SANTE
Responsible Party
Principal Investigator
Principal Investigator

PAGES Helene

Principal Investigator

Association d' Utilisation du Rein Artificiel SANTE

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

Outcomes

Primary Outcomes

Glomerular filtration rate

Time Frame: Every 6 months for 24 months

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

Secondary Outcomes

  • 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 alcaline reserve levels(Every 6 months for 24 months)
  • 24h salt consumption(Every 6 months for 24 months)
  • Plasma Phosphate levels(Every 6 months for 24 months)
  • Plasma parathyroid hormone levels(Every 6 months for 24 months)
  • 24h protein consumption(Every 6 months for 24 months)
  • Quality of life score(through study completion, an average of 6 months)

Study Sites (1)

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