Chronic Renal FailureINNOV-CKD testNCT05765630
Evaluation of Two New Innovative Haemostasis Tests: Measurement of the Active Form of GTP-bound Rap1b (aRap1b) in Platelets and the Pro and Antithrombotic Balance of Circulating Endothelial Microvesicles (patEMV) (INNOV-CKD Test)
A study testing BLOOD SAMPLES in people with Chronic Renal Failure, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The aim of this PROJECT is to develop two biomarkers to assess the thrombotic and hemorrhagic risk of patients with chronic renal failure (CKD) treated with antiplatelet drugs following the occurrence of an acute coronary syndrome (ACS). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- BLOOD SAMPLES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2023to Mar 2024
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects (group 1): DFG>70 ml/mn/1.73m2 in CKD-EPi, Age 18-85 years old, Consent required, Affiliated to social security.
- Antiplatelet agents-naïve CKD patients (group 2): DFG<30 ml/mn/1.73m2 in CKD-EPi, Age 18-85 years old, Consent required, Affiliated to social security.
- CKD patients receiving antiplatelet agents (group 3): DFG<30 ml/mn/1.73m2 in CKD-EPi, receiving antiplatelet agents, Age 18-85 years old, consent required, Affiliated with social security.
- Patients with constitutional platelet dysfunction (group 4): DFG>70 ml/min/1.73m2 in CKD-EPi, Age 18-85 years old, Consent required, Social Security Affiliated, Constitutional haemorrhagic syndrome
- Coronary patients (group 5): DFG>70 ml/mn/1.73m2 in CKD-EPi, Age 18-85 years old, Consent required, Social Security Affiliated, Acute Coronary Syndrome in the previous month requiring AAP.
Who cannot join
- For all the groups : subjects refusing to participate in the study, pregnant or breastfeeding women, minors (except for special consent), adults subject to a legal protection measure or unable to express their consent (persons under guardianship or curatorship), persons deprived of their rights of liberty by judicial or administrative decision (persons in a situation of social fragility), persons at the end of life.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13008
BURTEY STEPHANE
BONELLO LAURENT
About this study
The aim of this PROJECT is to develop two biomarkers to assess the thrombotic and hemorrhagic risk of patients with chronic renal failure (CKD) treated with antiplatelet drugs following the occurrence of an acute coronary syndrome (ACS). These biomarkers will help to adapt antiplatelet therapy on an individual basis (intensity, duration of antiplatelet treatment) and thus reduce the risk of thrombotic and hemorrhagic events in this particularly fragile population. The methods for measuring these two highly innovative biomarkers are currently being developed. The first biomarker corresponds to the measurement of an intraplatelet molecule, Rap1b in its active form (aRap1b). The second biomarker is the measurement of the pro-antithrombotic balance of circulating endothelial microvesicles (patEMV), a reflection of endothelial dysfunction. An automated method for biomarker measurement will be developed in partnership with the industrial partners Stago and BioCytex during the project.
- Conditions
- Chronic Renal Failure
- Being tested
- BLOOD SAMPLES
- 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.
BLOOD SAMPLESBiological
BLOOD SAMPLES
| Study group | Role | What they receive |
|---|---|---|
| Healthy patients | Active comparator | Not described Receives: Biological: BLOOD SAMPLES |
| CKD patients not receiving antiplatelet agents | Experimental | Not described Receives: Biological: BLOOD SAMPLES |
| CKD patients receiving antiplatelet agents | Experimental | Not described Receives: Biological: BLOOD SAMPLES |
| Patients with constitutional thrombopathy with RAP1B activation defect | Experimental | Not described Receives: Biological: BLOOD SAMPLES |
| Patients with ACS in the previous month treated with antiplatelet agents | Experimental | Not described Receives: Biological: BLOOD SAMPLES |
What is being measured
The primary outcome is the main question the study is designed to answer.
aRap1b assay reproducibility
intraclass correlation coefficient and its 95% confidence interval (CI) for assessing the reproducibility over time of aRap1b-GTP for subjects from groups 1, 2, 3, and 5.
Measured: 1 year
Secondary outcomes (4)
Reproducibility of pat EMV
intraclass correlation coefficient and its 95% confidence interval (CI) for assessing the reproducibility over time of microvesicle derived functional assays for subjects from groups 1, 2, 3, and 5.
Measured: 1 year
Repeatability
Coefficient of variation will be determined for different levels of concentration of the analytes (aRap1b resting and activates states and pat EMV)
Measured: 1 year
Analytical specificity
Best threshold values between samples containing the analyte (aRap1B) compared to negative samples which do not contain the analyte.
Measured: 1 year
Range of values in each group
Mean, standard deviation, median, interquartile range
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start8 Mar 2023
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent BONELLO, Pr., Principal investigator, Service cardiologie Hopital Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765630
- Sponsor's protocol ID
- RCAPHM20_0328
- Other IDs
- 2020-A01264-35_
- Acronym
- INNOV-CKD test
- Status last verified
- Mar 2023
- First submitted
- 1 Feb 2023
- Last updated
- 13 Mar 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 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two New Innovative Haemostasis Tests: Measurement of the Active Form of GTP-bound Rap1b (aRap1b) in Platelets and the Pro and Antithrombotic Balance of Circulating Endothelial Microvesicles (patEMV) (INNOV-CKD Test)
- ClinicalTrials.gov ID
- NCT05765630
- Acronym / sponsor ID
- INNOV-CKD test / RCAPHM20_0328
- Conditions
- Chronic Renal Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 13 Mar 2023 (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.
The aim of this PROJECT is to develop two biomarkers to assess the thrombotic and hemorrhagic risk of patients with chronic renal failure (CKD) treated with antiplatelet drugs following the occurrence of an acute coronary syndrome (ACS). These biomarkers will help to adapt antiplatelet therapy on an individual basis (intensity, duration of antiplatelet treatment) and thus reduce the risk of thrombotic and hemorrhagic events in this particularly fragile population. The methods for measuring these two highly innovative biomarkers are currently being developed. The first biomarker corresponds to the measurement of an intraplatelet molecule, Rap1b in its active form (aRap1b). The second biomarker is the measurement of the pro-antithrombotic balance of circulating endothelial microvesicles (patEMV), a reflection of endothelial dysfunction. An automated method for biomarker measurement will be developed in partnership with the industrial partners Stago and BioCytex during the project.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy patients | Active comparator | Biological: BLOOD SAMPLES |
| CKD patients not receiving antiplatelet agents | Experimental | Biological: BLOOD SAMPLES |
| CKD patients receiving antiplatelet agents | Experimental | Biological: BLOOD SAMPLES |
| Patients with constitutional thrombopathy with RAP1B activation defect | Experimental | Biological: BLOOD SAMPLES |
| Patients with ACS in the previous month treated with antiplatelet agents | Experimental | Biological: BLOOD SAMPLES |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy subjects (group 1): DFG>70 ml/mn/1.73m2 in CKD-EPi, Age 18-85 years old, Consent required, Affiliated to social security.
- Antiplatelet agents-naïve CKD patients (group 2): DFG<30 ml/mn/1.73m2 in CKD-EPi, Age 18-85 years old, Consent required, Affiliated to social security.
- CKD patients receiving antiplatelet agents (group 3): DFG<30 ml/mn/1.73m2 in CKD-EPi, receiving antiplatelet agents, Age 18-85 years old, consent required, Affiliated with social security.
- Patients with constitutional platelet dysfunction (group 4): DFG>70 ml/min/1.73m2 in CKD-EPi, Age 18-85 years old, Consent required, Social Security Affiliated, Constitutional haemorrhagic syndrome
- Coronary patients (group 5): DFG>70 ml/mn/1.73m2 in CKD-EPi, Age 18-85 years old, Consent required, Social Security Affiliated, Acute Coronary Syndrome in the previous month requiring AAP.
Key exclusion criteria (1 listed)
- For all the groups : subjects refusing to participate in the study, pregnant or breastfeeding women, minors (except for special consent), adults subject to a legal protection measure or unable to express their consent (persons under guardianship or curatorship), persons deprived of their rights of liberty by judicial or administrative decision (persons in a situation of social fragility), persons at the end of life.
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 |
|---|---|---|
| BLOOD SAMPLESBLOOD SAMPLES | Biological | CKD patients not receiving antiplatelet agents, CKD patients receiving antiplatelet agents, Healthy patients, Patients with ACS in the previous month treated with antiplatelet agents, Patients with constitutional thrombopathy with RAP1B activation defect |
Primary outcome
aRap1b assay reproducibility
Time frame: 1 year
intraclass correlation coefficient and its 95% confidence interval (CI) for assessing the reproducibility over time of aRap1b-GTP for subjects from groups 1, 2, 3, and 5.
4 secondary outcomes
Reproducibility of pat EMV
Time frame: 1 year
Repeatability
Time frame: 1 year
Analytical specificity
Time frame: 1 year
Range of values in each group
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 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.
Laurent BONELLO, Pr. principal investigator
Service cardiologie Hopital Nord
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BLOOD SAMPLES 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephane BURTEY, Pr. (+33(0)634603257, stephane.burtey@univ-amu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aRap1b assay reproducibility (time frame: 1 year). 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 13 Mar 2023.