Chronic Renal DiseaseBioClaCKNCT03274921
Biomarkers of Cardiovascular Complications in Chronic Kidney Disease
An observational study of Chronic Renal Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Identification of new retention solutes associated with cardiovascular (CV) toxicity in Chronic Kidney Disease (CKD) patients will help to better understand the pathophysiological mechanisms at stake and to prevent CKD-associated mortality and morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Disease
- What is being tested?
- Biological determination
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2017to 30 Jun 2020
- Phase
- Observational
- 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
Study population: Cohort of patients consulting in University Hospital toulouse
Who may be able to join
- patient with stage 4 or 5 CKD.
Who cannot join
- patient with stage 1, 2 or 3 CKD
- patient with solid tumor
- patient with malignant blood disease
- patient with acute kidney disease in the past 3 months
- patient with acute glomerulonephritis in the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of BIOmarkers for Detection and Understanding of Cardiovascular Complications in Chronic Kidney Disease
Identification of new retention solutes associated with cardiovascular (CV) toxicity in Chronic Kidney Disease (CKD) patients will help to better understand the pathophysiological mechanisms at stake and to prevent CKD-associated mortality and morbidity. For a molecule to be defined as a toxic retention solute, plasma accumulation in the course of CKD has to be demonstrated but also proof needs to be made that plasma accumulation during CKD is indeed associated with an increased risk of CV complications. Moreover, precise determination of the plasma concentration has to be performed in order to later study in vitro and in vivo the toxic mechanisms involved. Based on previous results of plasma proteome analysis using mass spectrometry, a previous study has selected 10 promising protein candidates. These proteins accumulated in the plasma of patients during CKD progression and are known to be associated with CV events in non-CKD patients. The objective of the present study is now to 1) evaluate the association of the plasma accumulation of the 10 retention solutes with CV complications in CKD patients and 2) determine their plasma concentration using ELISA. One hundred and seventy six patients with advanced CKD will be included and divided in 2 groups: 44 patients with history of CV complications in the past 4 years and 132 patients free of any CV complications.
- Conditions
- Chronic Renal Disease
- Being tested
- Biological determination
- Keywords
- cardiovascular complications, biomarkers
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological determinationDiagnostic test
Evaluation of plasma accumulation of the 10 retention solutes with CV complications in CKD patients
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular complication | patients with history of CV complications in the past 4 years had biological determination Receives: Diagnostic Test: Biological determination | |
| No cardiovascular complication | patients free of any CV complications had biological determination Receives: Diagnostic Test: Biological determination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma accumulation of new retention solutes
evaluate the plasma accumulation of the 10 retention solutes using mass spectrometry
Measured: Day 0
Secondary outcomes (1)
determine their plasma concentration
determine their plasma concentration using ELISA
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start1 Sep 2017
- Primary completion31 Dec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanislas FAGUER, MD, Principal investigator, University Hosptial Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274921
- Sponsor's protocol ID
- RC31/16/8250
- Other IDs
- University Hospital Toulouse
- Acronym
- BioClaCK
- Status last verified
- Jul 2020
- First submitted
- 1 Sep 2017
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of BIOmarkers for Detection and Understanding of Cardiovascular Complications in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03274921
- Acronym / sponsor ID
- BioClaCK / RC31/16/8250
- Conditions
- Chronic Renal Disease
- Keywords
- cardiovascular complications, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 7 Sep 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.
Identification of new retention solutes associated with cardiovascular (CV) toxicity in Chronic Kidney Disease (CKD) patients will help to better understand the pathophysiological mechanisms at stake and to prevent CKD-associated mortality and morbidity. For a molecule to be defined as a toxic retention solute, plasma accumulation in the course of CKD has to be demonstrated but also proof needs to be made that plasma accumulation during CKD is indeed associated with an increased risk of CV complications. Moreover, precise determination of the plasma concentration has to be performed in order to later study in vitro and in vivo the toxic mechanisms involved. Based on previous results of plasma proteome analysis using mass spectrometry, a previous study has selected 10 promising protein candidates. These proteins accumulated in the plasma of patients during CKD progression and are known to be associated with CV events in non-CKD patients. The objective of the present study is now to 1) evaluate the association of the plasma accumulation of the 10 retention solutes with CV complications in CKD patients and 2) determine their plasma concentration using ELISA. One hundred and seventy six patients with advanced CKD will be included and divided in 2 groups: 44 patients with history of CV complications in the past 4 years and 132 patients free of any CV complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular complication | – | Diagnostic Test: Biological determinationpatients with history of CV complications in the past 4 years had biological determination |
| No cardiovascular complication | – | Diagnostic Test: Biological determinationpatients free of any CV complications had biological determination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of patients consulting in University Hospital toulouse
Key inclusion criteria (1 listed)
- patient with stage 4 or 5 CKD.
Key exclusion criteria (5 listed)
- patient with stage 1, 2 or 3 CKD
- patient with solid tumor
- patient with malignant blood disease
- patient with acute kidney disease in the past 3 months
- patient with acute glomerulonephritis in the past 6 months.
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 |
|---|---|---|
| Biological determinationEvaluation of plasma accumulation of the 10 retention solutes with CV complications in CKD patients | Diagnostic test | Cardiovascular complication, No cardiovascular complication |
Primary outcome
Plasma accumulation of new retention solutes
Time frame: Day 0
evaluate the plasma accumulation of the 10 retention solutes using mass spectrometry
1 secondary outcome
determine their plasma concentration
Time frame: Day 0
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 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Stanislas FAGUER, MD principal investigator
University Hosptial Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Renal Disease, run by University Hospital, Toulouse 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 1 inclusion and 5 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 Jul 2020. 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?
Plasma accumulation of new retention solutes (time frame: Day 0). 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 Jul 2020.