NCT03341949

Brief Summary

Chronic renal disease (CKD) is defined as a decrease in glomerular filtration rate (GFR) and / or proteinuria or albuminuria (a protein present in urine). Albuminuria is considered a marker of endothelial dysfunction. Proteinuria and / or albuminuria are recognized as cardiovascular risk factors in both diabetic and non-diabetic populations, independently of GFR. It is also a marker of progression of kidney disease. cluster of differentiation 146 (CD146) is an endothelial adhesion molecule with preferential localization in the junction. Soluble CD146 (or CD146s). CD146s is a biomarker of endothelial dysfunction that is easy to assay. The increase in CD146 levels was described during the MRC, especially in diabetic patients with significant proteinuria. In two independent cohorts of patients with CDR, CD146s did not correlate with creatinine or GFR but appeared to correlate with proteinuria. The aim of our study is to determine whether the blood concentration of CD146s is correlated with proteinuria independently of GFR. For this purpose, we propose this study in the kidney nephrology and transplantation center of Conception Hospital, with the objective of highlighting the link between proteinuria and serum CD146 levels in patients with CKD, whatever their renal function and / or underlying pathology. 205 patients will be included over two years with dosing of CD146s and proteinuria at the same time. These 205 patients will be recruited at each stage of the CKD (41 in each arm). CD146s could be a new biomarker predicting the risk of renal function impairment or cardiovascular risk independent of renal function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

February 28, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2020

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2023

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

November 9, 2017

Last Update Submit

May 26, 2023

Conditions

Chronic Renal Failure

Outcome Measures

Primary Outcomes (2)

  • Serum CD146s assay

    determining the blood concentration of CD146s is correlated with proteinuria regardless of glomerular filtration rate (GFR).

    12 months

  • The dosage of proteinuria

    determining the blood concentration of CD146s is correlated with proteinuria regardless of glomerular filtration rate (GFR).

    12 months

Study Arms (1)

Patient with chronic kidney disease

EXPERIMENTAL

Determination of the Cluster of Differentiation 146 (CD146)

Biological: Recurring blood sample

Interventions

Recurring blood sampleBIOLOGICAL

An additional tube will be collected for the assay of CD146s as part of the research

Patient with chronic kidney disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult subject aged 18 years or over
  • Subject capable of giving informed consent
  • Patient with chronic kidney disease (stage 1 to 5 CKD regardless of etiology)

You may not qualify if:

  • Pregnant or lactating woman
  • Person deprived of liberty or hospitalized without consent
  • Major under legal protection or unable to express his consent
  • Refusal of the patient
  • Patient with a history of kidney transplantation
  • Evolutionary cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Olivier ARNAUD, Director

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2017

First Posted

November 14, 2017

Study Start

February 28, 2018

Primary Completion

February 27, 2020

Study Completion

May 26, 2023

Last Updated

May 30, 2023

Record last verified: 2023-05

Locations

FR(1)