Soluble CD146 and Proteinuria in Chronic Renal Disease

Chronic Renal Failure Clinical Trial

— CPinMRC  

Official title:

Soluble CD146 and Proteinuria in Chronic Renal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341949
• Other study ID #: 2017-12
• Secondary ID: ID RCB
• Status: Completed
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: May 26, 2023

Study information

• Verified date: May 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: May 26, 2023
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Proteinuria
• Renal Insufficiency, Chronic

Intervention

Biological:
• Recurring blood sample
An additional tube will be collected for the assay of CD146s as part of the research

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum CD146s assay	determining the blood concentration of CD146s is correlated with proteinuria regardless of glomerular filtration rate (GFR).	12 months
Primary	The dosage of proteinuria	determining the blood concentration of CD146s is correlated with proteinuria regardless of glomerular filtration rate (GFR).	12 months