- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05765630
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) (INNOV-CKD test)
March 9, 2023 updated by: Assistance Publique Hopitaux De Marseille
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
115
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stephane BURTEY, Pr.
- Phone Number: +33(0)634603257
- Email: stephane.burtey@univ-amu.fr
Study Contact Backup
- Name: Alexandra GIULIANI
- Phone Number: +33(0)491382870
- Email: alexandra.giuliani@ap-hm.fr
Study Locations
-
-
-
Marseille, France, 13008
- Recruiting
- Assistance Publique Hopitaux de Marseille
-
Principal Investigator:
- BURTEY STEPHANE
-
Principal Investigator:
- BONELLO LAURENT
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Healthy patients
|
BLOOD SAMPLES
|
Experimental: CKD patients not receiving antiplatelet agents
|
BLOOD SAMPLES
|
Experimental: CKD patients receiving antiplatelet agents
|
BLOOD SAMPLES
|
Experimental: Patients with constitutional thrombopathy with RAP1B activation defect
|
BLOOD SAMPLES
|
Experimental: Patients with ACS in the previous month treated with antiplatelet agents
|
BLOOD SAMPLES
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reproducibility of pat EMV
Time Frame: 1 year
|
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.
|
1 year
|
Repeatability
Time Frame: 1 year
|
Coefficient of variation will be determined for different levels of concentration of the analytes (aRap1b resting and activates states and pat EMV)
|
1 year
|
Analytical specificity
Time Frame: 1 year
|
Best threshold values between samples containing the analyte (aRap1B) compared to negative samples which do not contain the analyte.
|
1 year
|
Range of values in each group
Time Frame: 1 year
|
Mean, standard deviation, median, interquartile range
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Laurent BONELLO, Pr., Service cardiologie Hopital Nord
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 8, 2023
Primary Completion (Anticipated)
March 1, 2024
Study Completion (Anticipated)
March 1, 2024
Study Registration Dates
First Submitted
February 1, 2023
First Submitted That Met QC Criteria
March 9, 2023
First Posted (Actual)
March 13, 2023
Study Record Updates
Last Update Posted (Actual)
March 13, 2023
Last Update Submitted That Met QC Criteria
March 9, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCAPHM20_0328
- 2020-A01264-35_ (Other Identifier: IDRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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