Chronic Renal FailureCPinMRCNCT03341949
Soluble CD146 and Proteinuria in Chronic Renal Disease
A study testing Recurring blood sample in people with Chronic Renal Failure, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Recurring blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2018to 26 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Recurring blood sample
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recurring blood sampleBiological
An additional tube will be collected for the assay of CD146s as part of the research
| Study group | Role | What they receive |
|---|---|---|
| Patient with chronic kidney disease | Experimental | Determination of the Cluster of Differentiation 146 (CD146) Receives: Biological: Recurring blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum CD146s assay
determining the blood concentration of CD146s is correlated with proteinuria regardless of glomerular filtration rate (GFR).
Measured: 12 months
The dosage of proteinuria
determining the blood concentration of CD146s is correlated with proteinuria regardless of glomerular filtration rate (GFR).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start28 Feb 2018
- Primary completion27 Feb 2020
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Director, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341949
- Sponsor's protocol ID
- 2017-12
- Other IDs
- ID RCB
- Acronym
- CPinMRC
- Status last verified
- May 2023
- First submitted
- 9 Nov 2017
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble CD146 and Proteinuria in Chronic Renal Disease
- ClinicalTrials.gov ID
- NCT03341949
- Acronym / sponsor ID
- CPinMRC / 2017-12
- Conditions
- Chronic Renal Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with chronic kidney disease | Experimental | Biological: Recurring blood sampleDetermination of the Cluster of Differentiation 146 (CD146) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recurring blood sampleAn additional tube will be collected for the assay of CD146s as part of the research | Biological | Patient with chronic kidney disease |
Primary outcome
Serum CD146s assay
Time frame: 12 months
determining the blood concentration of CD146s is correlated with proteinuria regardless of glomerular filtration rate (GFR).
The dosage of proteinuria
Time frame: 12 months
determining the blood concentration of CD146s is correlated with proteinuria regardless of glomerular filtration rate (GFR).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Olivier ARNAUD, Director study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recurring blood sample in people with Chronic Renal Failure, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum CD146s assay (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.