Role of Epoxyeicosatrienoic Acids in Chronic Allograft Nephropathy - The TRANSPLANT-EETs Study
NCT ID: NCT02555566
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2014-03-31
2016-12-31
Brief Summary
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The main goal of the investigators' study is to evaluate whether genetic polymorphisms of specific enzymes responsible for the bioavailability of EETs are associated with post-transplant kidney function.
To this end, 80 kidney transplant recipients will be included. Prespecified genetic polymorphisms of CYP 2J2, CYP 2C8, CYP 2C9, CYP 2C9, CYP 2C19 and EPHX2 will be determined. Kidney function will be recorded 3, 6, 12 and 36 months after transplantation. Flow-mediated dilatation, EETs and circulating biomarkers of endothelial function will be measured in the radial artery.
The expected results of this study to provide preliminary evidence supporting a beneficial role of an increase in the bioavailability of EETs in kidney transplant recipients.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Kidney transplant recipients
blood sampling is done for determination of EPHX Lys55Arg and other polymorphisms status in Kidney transplant recipients.
flow-mediated distal stimulation of the forearm radial artery by cutaneous heating is assessed for evaluation of EEts level in Kidney transplant recipients.
Blood sampling
Blood sampling is done for Kidney transplant recipients for evaluation of the polymorphisms and EETs dosage
flow-mediated distal stimulation of the forearm radial artery by cutaneous heating
Flow-mediated distal stimulation of the forearm radial artery by cutaneous heating for Kidney transplant recipients
Interventions
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Blood sampling
Blood sampling is done for Kidney transplant recipients for evaluation of the polymorphisms and EETs dosage
flow-mediated distal stimulation of the forearm radial artery by cutaneous heating
Flow-mediated distal stimulation of the forearm radial artery by cutaneous heating for Kidney transplant recipients
Eligibility Criteria
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Inclusion Criteria
* Caucasian (because of different CYP epoxygenase polymorphisms)
* First kidney transplantation performed in Rouen University Hospital after 2000, and at least 12 months before inclusion
* Patient having read, understood and approved the informed consent
* Efficient contraception in child-bearing aged women
* Regular health insurance
Exclusion Criteria
* Previous kidney transplantation
* History of psychiatric, psychologic or sensorial disorder preventing the patient from correctly understanding the protocol
* History of bilateral arm or forearm arteriovenous fistula
* Counter-indication to trinitrin
* Insufficient understanding of written or spoken French language
* Liberty-deprived patient
* Pregnancy or absence of contraception in child-bearing aged women
* Patient enrolled in another research protocol within 2 weeks before inclusion
18 Years
75 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Dominique GUERROT, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Rouen University Hospital
Rouen, , France
Countries
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Other Identifiers
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2013/150/HP
Identifier Type: -
Identifier Source: org_study_id