Soluble CD146 and Proteinuria in Chronic Renal Disease

NCT ID: NCT03341949

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2023-05-26

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.

Conditions

Chronic Renal Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patient with chronic kidney disease

Determination of the Cluster of Differentiation 146 (CD146)

Group Type: EXPERIMENTAL

Recurring blood sample

Intervention Type: BIOLOGICAL

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

Interventions

Recurring blood sample

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Olivier ARNAUD, Director

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

ID RCB

Identifier Type: REGISTRY

Identifier Source: secondary_id

2017-12

Identifier Type: -

Identifier Source: org_study_id