Back to resultsSoluble CD146 and Proteinuria in Chronic Renal Disease (CPinMRC)
Primary Purpose
Chronic Renal Failure
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Recurring blood sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Renal Failure
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
Sites / Locations
- Assistance Publique Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with chronic kidney disease
Arm Description
Determination of the Cluster of Differentiation 146 (CD146)
Outcomes
Primary Outcome Measures
Serum CD146s assay
determining the blood concentration of CD146s is correlated with proteinuria regardless of glomerular filtration rate (GFR).
The dosage of proteinuria
determining the blood concentration of CD146s is correlated with proteinuria regardless of glomerular filtration rate (GFR).
Secondary Outcome Measures
Full Information
NCT ID
NCT03341949
First Posted
November 9, 2017
Last Updated
May 26, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03341949
Brief Title
Soluble CD146 and Proteinuria in Chronic Renal Disease
Acronym
CPinMRC
Official Title
Soluble CD146 and Proteinuria in Chronic Renal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
May 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with chronic kidney disease
Arm Type
Experimental
Arm Description
Determination of the Cluster of Differentiation 146 (CD146)
Intervention Type
Biological
Intervention Name(s)
Recurring blood sample
Intervention Description
An additional tube will be collected for the assay of CD146s as part of the research
Primary Outcome Measure Information:
Title
Serum CD146s assay
Description
determining the blood concentration of CD146s is correlated with proteinuria regardless of glomerular filtration rate (GFR).
Time Frame
12 months
Title
The dosage of proteinuria
Description
determining the blood concentration of CD146s is correlated with proteinuria regardless of glomerular filtration rate (GFR).
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier ARNAUD, Director
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Learn more about this trial
Soluble CD146 and Proteinuria in Chronic Renal Disease
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