Soluble CD146 and Proteinuria in Chronic Renal Disease

Not Applicable

Completed

• Conditions: Chronic Renal Failure
• Interventions: Biological: Recurring blood sample

• Registration Number: NCT03341949
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-13
• Study First Posted: 2017-11-14
• Study Start: 2018-02-28
• Primary Completion: 2020-02-27
• Status Verified: 2023-05
• Study Completion: 2023-05-26
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with chronic kidney disease	Recurring blood sample	Determination of the Cluster of Differentiation 146 (CD146)

Primary Outcome Measures

Name	Time	Method
Serum CD146s assay	12 months	determining the blood concentration of CD146s is correlated with proteinuria regardless of glomerular filtration rate (GFR).
The dosage of proteinuria	12 months	determining the blood concentration of CD146s is correlated with proteinuria regardless of glomerular filtration rate (GFR).

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France