NCT03954470

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2012

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
Last Updated

May 17, 2019

Status Verified

May 1, 2019

Enrollment Period

6.7 years

First QC Date

May 13, 2019

Last Update Submit

May 16, 2019

Conditions

Chronic Kidney Disease stage4

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with GFR ≥30mL / min / 1.73m2 or \<15mL / min / 1.73m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Besançon

Besançon, 25000, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 17, 2019

Study Start

April 9, 2012

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

May 17, 2019

Record last verified: 2019-05

Locations

FR(1)