Factors Influencing Risk of Progression of Chronic Kidney Disease (FAIR-PROGRESS)

Factors Influencing Risk of Progression of Chronic Kidney Disease in Patients With Severe Renal Failure

The aim of this study is to identify typical patterns of renal function evolution in patients with stage 4 chronic kidney disease, regularly followed in nephrology consultation and included in a French cohort.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease stage4

• Study Type: Observational
• Enrollment (Actual): 1300

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • Centre Hospitalier Universitaire de Besançon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult population with chronic renal failure, before replacement therapy, followed in 9 nephrology departments of Bourgogne Franche-Comté.

Description

Inclusion Criteria:

• Patients meeting the inclusion criteria of the ND-CRIS cohort (long-term follow-up in one of the centers participating in the research, with a GFR <60mL/min /1.73m2)
• Patients included in the ND-CRIS cohort on the date when the estimate of their GFR is strictly less than 30mL/min/1.73m2 and greater than or equal to 15mL/min/1.73m2 (MDRD equation).

Patients should have at least two measurements of GFR <30mL/min/1.73m2 to be included, at least one of them greater than or equal to 15mL/min/1.73m2. The date of the first GFR <30mL/min/ 1.73m2 will be considered as the date of origin.

Exclusion Criteria:

• Patients with GFR ≥30mL / min / 1.73m2 or <15mL / min / 1.73m2
• Patients who do not meet the inclusion criteria of ND-CRIS cohort (dialysis patients, transplant patients, unfollowed patients)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of estimated Glomerular Filtration Rate (GFR) according to MDRD equation (modification of diet in renal disease) at each visit		up to 3 years
Time between inclusion and occurrence of the "progression" event	progression: initiation of an extra-renal purification technique or reduction of GFR of at least 5 mL / min / 1.73m2 compared to inclusion in FAIR-PROGRESS	up to 3 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2012
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: API/2017/87

Drug and device information, study documents

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