Factors Influencing Risk of Progression of Chronic Kidney... | NCT03954470

Studies
Factors Influencing Risk of Progression of Chronic Kidney Disease

NCT03954470

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

May 17, 2019Actual

Enrollment

1,300Actual

Phase

Not provided

Conditions

Chronic Kidney Disease stage4

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 9, 2012Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

May 13, 2019

First Submission Date that Met QC Criteria

May 16, 2019

First Posted Date

May 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2019

Last Update Posted Date

May 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,300Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample