Potential Biomarkers of the Severity of Endothelial Damag... | NCT02857556

Studies
Potential Biomarkers of the Severity of Endothelial Damage in End-stage Chronic Kidney Failure

NCT02857556

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Terminated

Last Update Posted

May 3, 2019Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

End-stage Chronic Kidney Failure

Interventions

Blood sample
Retinal photography:
dialyse

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

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of inclusions

Expanded Access Info

Start Date

Apr 17, 2014Actual

Primary Completion Date

Jun 30, 2017Actual

Completion Date

Jun 30, 2017Actual

First Submitted Date

Aug 2, 2016

First Submission Date that Met QC Criteria

Aug 2, 2016

First Posted Date

Aug 5, 2016Estimated

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 2, 2019

Last Update Posted Date

May 3, 2019Actual

Description Module

Brief Summary

The principal objective of this study is to qualify markers of oxidative stress in inflammatory cells (monocytes) in patients with stage 3 kidney failure (diabetic or not), and patients with end-stage kidney failure (diabetic or not), who require dialysis. The evaluation of these markers will be done by the activation and localization of proteins implicated in vascular tone and oxidative stress in monocytes, correlated with the distribution of cholesterol sphingomyelin within planar rafts and caveolae. The aim is to describe their evolution under treatment, which could lead to interventional studies.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group with stage 3 kidney failure (diabetic or not)	Other		Biological: Blood sample Other: Retinal photography:
group with stage 5 kidney failure (diabetic or not)	Other		Biological: Blood sample Other: dialyse

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Biological		group with stage 3 kidney failure (diabetic or not) group with stage 5 kidney failure (diabetic or not)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Activation of 5 proteins relocated in the membrane of monocytes (eNOS, iNOS, gp91phox and receptors of angiotensin II (AT1 and AT2)) within dynamic lipid structures, rafts, measured by western blot-dot blot.		at the beginning of the period Day 0, at 1 month and at 3 months.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient who have been informed about the research
Patients with national health insurance cover
Patients aged between 18 and 75 years
Patients with stage 3 kidney failure (30 ml/min < cl creat < 59 ml/min) diabetic or not
Patients with stage 5 kidney failure (cl creat < 15 ml/mn) diabetic or not and requiring dialysis.

Exclusion Criteria:

Patients under guardianship
Pregnant or breast-feeding women
Infection (including peritonitis in peritoneal dialysis, infection of the catheter insertion site),
Neoplastic disease,
Systemic diseases in flare,
Patients positive for Human Immunodeficience Virus (HIV),
Patients on immunosuppressants
Patients taking antioxidants (selenium, vitamin C and/or E)
Patient on statins

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Dijon Bourgogne		Dijon		21079	France

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