Factors Influencing Risk of Progression of Chronic Kidney Disease

Chronic Kidney Disease stage4 Clinical Trial

— FAIR-PROGRESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954470
• Other study ID #: API/2017/87
• Status: Completed
• Start date: April 9, 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Kidney Disease stage4
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of estimated Glomerular Filtration Rate (GFR) according to MDRD equation (modification of diet in renal disease) at each visit		up to 3 years
Primary	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