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)

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: Chronic Renal Failure
• Intervention / Treatment: Biological: BLOOD SAMPLES

• Study Type: Interventional
• Enrollment (Anticipated): 115
• Phase: Not Applicable

Contacts and Locations

• 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

• France
  • Marseille, France, 13008
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
    • Principal Investigator: BURTEY STEPHANE
    • Principal Investigator: BONELLO LAURENT

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy patients	Biological: BLOOD SAMPLES; BLOOD SAMPLES
Experimental: CKD patients not receiving antiplatelet agents	Biological: BLOOD SAMPLES; BLOOD SAMPLES
Experimental: CKD patients receiving antiplatelet agents	Biological: BLOOD SAMPLES; BLOOD SAMPLES
Experimental: Patients with constitutional thrombopathy with RAP1B activation defect	Biological: BLOOD SAMPLES; BLOOD SAMPLES
Experimental: Patients with ACS in the previous month treated with antiplatelet agents	Biological: BLOOD SAMPLES; BLOOD SAMPLES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	1 year
Analytical specificity	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	Mean, standard deviation, median, interquartile range	1 year

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: Laurent BONELLO, Pr., Service cardiologie Hopital Nord

Study record dates

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: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• 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