Cohort Follow-up: Progression and Consequences of Chronic... | NCT04070885

Studies
Cohort Follow-up: Progression and Consequences of Chronic Kidney Disease.

NCT04070885

Sponsor

University Hospital, Bordeaux

Status

Completed

Last Update Posted

Aug 28, 2019Actual

Enrollment

210Actual

Phase

Not provided

Conditions

Chronic Renal Diseases
Renal Function Disorder

Interventions

Blood sample
Urine sample

Countries

Not provided

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

Aug 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

Jan 5, 2011Actual

Primary Completion Date

Mar 20, 2015Actual

Completion Date

Mar 20, 2015Actual

First Submitted Date

Aug 22, 2019

First Submission Date that Met QC Criteria

Aug 26, 2019

First Posted Date

Aug 28, 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

Aug 26, 2019

Last Update Posted Date

Aug 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study aims to conduct a prospective collection of clinical and para-clinical data in patients with Chronic Renal Diseases to identify disease progression factors, markers of renal function, and the pathophysiology of Chronic Renal Diseases complications.

Detailed Description

Chronic Renal Diseases have a growing incidence and prevalence in France, with significant consequences in terms of morbidity and mortality, especially cardiovascular, and Public Health.

It is necessary to know better:

the mechanisms leading to the progression of the Chronic Renal Diseases
markers to quantify renal function and progression of the Chronic Renal Diseases
the pathophysiology of Chronic Renal Diseases complications, cardiovascular, nutritional, or mineral metabolism in particular.

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

Retention

Enrollment

210Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Procedure	A dry tube of 7 ml of blood, two 4 ml EDTA tubes, a 4 ml heparinized tube and an 8.5 ml ACD-A tube will be collected from the patient.
Urine sample	Procedure	The urine will be taken from three 15 ml tubes.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Estimated Glomerular Filtration Rate measurement	by isotope technique	At 1 year after inclusion
Estimated Glomerular Filtration Rate measurement	by isotope technique	At 2 year after inclusion
Measured Glomerular Filtration Rate	by isotope technique	At 1 year after inclusion
Measured Glomerular Filtration Rate	by isotope technique	At 2 years after inclusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Chronic Renal Disease, stage 2 to 5, non-dialysis patients over the age of 18,
followed in the Nephrology Department of the Bordeaux University Hospital
agreeing to participate in NephroTest
affiliated with social security.

Exclusion Criteria:

Patients under 18 years
Patients with acute or rapidly progressive renal failure
Patients with severe comorbidities or comorbidities that are life-threatening in the short term (<1 year)
Patients who did not give their written consent to be included in the study
Major incapacitated patients and psychiatric patients admitted to hospital

Accepts Healthy Volunteers

Not provided

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

The participation in NephroTest will be offered to eligible patients by the doctors of the Nephrology Department, during consultations or as a result of hospitalization.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian COMBE, Pr	University Hospital, Bordeaux	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided

Description

A dry tube of 7 ml of blood, two 4 ml ethylene-diamine-tetra-acetic acid tubes, a 4 ml heparinized tube and an 8.5 ml citrate dextrose acid tube will be collected from the patient.

The urine will be taken from three 15 ml tubes.