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Completed

NCT Number: NCT02555566

Role of Epoxyeicosatrienoic Acids in Chronic Allograft Nephropathy - The TRANSPLANT-EETs Study

Endothelial lesions within the transplanted kidney are a major determinant of chronic allograft nephropathy. Epoxyeicosatrienoic acids (EETs) are endothelium-derived hyperpolarizing factors with anti-inflammatory, antiproliferative and vasodilator properties.

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.

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Key information

Conditions

Kidney Transplant Recipients

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged 18 to 75 yo
  • 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

  • Primary non-function, or allograft loss before 1 year
  • 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

Treatment and study plan

blood sampling

Procedure

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

Procedure

Flow-mediated distal stimulation of the forearm radial artery by cutaneous heating for Kidney transplant recipients

Primary outcomes

  1. Difference between patients with the EPHX2 Lys55Arg polymorphism and patients without in estimated Glomerular Filtration Rate (eGFR)

    Time frame: 12 Months after transplantation

    eGFR Scores range from 0 [kidney failure] to >90 [normal function]

Secondary outcomes

  1. Difference between patients with the EPHX2 Lys55Arg polymorphism and patients without in estimated Glomerular Filtration Rate (eGFR)

    Time frame: 3 Months after transplantation

    eGFR Scores range from 0 [kidney failure] to >90 [normal function]

  2. Difference between patients with the EPHX2 Lys55Arg polymorphism and patients without in estimated Glomerular Filtration Rate (eGFR)

    Time frame: 6 Months after transplantation

    eGFR Scores range from 0 [kidney failure] to >90 [normal function]

  3. Difference between patients with the EPHX2 Lys55Arg polymorphism and patients without in estimated Glomerular Filtration Rate (eGFR)

    Time frame: 36 Months after transplantation

    eGFR Scores range from 0 [kidney failure] to >90 [normal function]

  4. Difference between patients with specified polymorphisms and patients without in estimated Glomerular Filtration Rate (eGFR)

    Time frame: 3 Months after transplantation

    eGFR Scores range from 0 [kidney failure] to >90 [normal function]

  5. Difference between patients with specified polymorphisms and patients without in estimated Glomerular Filtration Rate (eGFR)

    Time frame: 6 Months after transplantation

    eGFR Scores range from 0 [kidney failure] to >90 [normal function]

  6. Difference between patients with specified polymorphisms and patients without in estimated Glomerular Filtration Rate (eGFR)

    Time frame: 12 Months after transplantation

    eGFR Scores range from 0 [kidney failure] to >90 [normal function]

  7. Difference between patients with specified polymorphisms and patients without in estimated Glomerular Filtration Rate (eGFR)

    Time frame: 36 Months after transplantation

    eGFR Scores range from 0 [kidney failure] to >90 [normal function]

  8. Difference between blood EETs concentration at baseline and after distal cutaneous heating for patients with the specified polymorphisms.

    Time frame: Day 1

    EEts plasma concentration is measured using liquid chromatography coupled to tandem mass spectrometry before and after distal cutaneous heating. Unit is ng per mL

  9. Difference between blood EETs concentration at baseline and after distal cutaneous heating for patients without the specified polymorphisms.

    Time frame: Day 1

    EEts plasma concentration is measured using liquid chromatography coupled to tandem mass spectrometry before and after distal cutaneous heating. Unit is ng per mL

  10. Difference between variation of diameter of the forearm radial artery after distal cutaneous heating for patients with the specified polymorphisms.

    Time frame: Day 1

    Variation of diameter of the radial artery is measured in millimeter.

  11. Difference between variation of diameter of the forearm radial artery after distal cutaneous heating for patients without the specified polymorphisms.

    Time frame: Day 1

    Variation of diameter of the radial artery is measured in millimeter.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Role of Epoxyeicosatrienoic Acids in Chronic Allograft Nephropathy

Acronym: TRANSPLANTEETs

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 21, 2015
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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