Soluble CD146 and Proteinuria in Chronic Renal Disease (CPinMRC)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Renal Failure
• Intervention / Treatment: Biological: Recurring blood sample

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with chronic kidney disease; Determination of the Cluster of Differentiation 146 (CD146)	Biological: Recurring blood sample; An additional tube will be collected for the assay of CD146s as part of the research

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: Jean-Olivier ARNAUD, Director, Assistance Publique Hopitaux de Marseille

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2018
• Primary Completion (Actual): February 27, 2020
• Study Completion (Actual): May 26, 2023

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 13, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Urological Manifestations; Disease Attributes; Renal Insufficiency; Urination Disorders; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Proteinuria
• Other Study ID Numbers: 2017-12; ID RCB (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No