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

NCT02555566 | Completed

• 1 other identifier: 2013/150/HP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplant Recipients

Outcome Measures

Primary Outcomes (1)

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

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

  12 Months after transplantation

Secondary Outcomes (11)

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

  3 Months after transplantation

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

  6 Months after transplantation

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

  36 Months after transplantation

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

  3 Months after transplantation

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

  6 Months after transplantation

Study Arms (1)

Kidney transplant recipients

EXPERIMENTAL

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.

Procedure: Blood sampling; Procedure: flow-mediated distal stimulation of the forearm radial artery by cutaneous heating

Interventions

Blood sampling PROCEDURE

Blood sampling is done for Kidney transplant recipients for evaluation of the polymorphisms and EETs dosage

Kidney transplant recipients

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

Kidney transplant recipients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 to 75 yo
• Caucasian (because of different CYP epoxygenase polymorphisms)
• Patient having read, understood and approved the informed consent
• Efficient contraception in child-bearing aged women
• Regular health insurance

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

Related Publications (1)

• Duflot T, Laurent C, Soudey A, Fonrose X, Hamzaoui M, Iacob M, Bertrand D, Favre J, Etienne I, Roche C, Coquerel D, Le Besnerais M, Louhichi S, Tarlet T, Li D, Brunel V, Morisseau C, Richard V, Joannides R, Stanke-Labesque F, Lamoureux F, Guerrot D, Bellien J. Preservation of epoxyeicosatrienoic acid bioavailability prevents renal allograft dysfunction and cardiovascular alterations in kidney transplant recipients. Sci Rep. 2021 Feb 12;11(1):3739. doi: 10.1038/s41598-021-83274-1.

  PMID: 33580125 RESULT

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Dominique GUERROT, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 21, 2015
• Study Start: March 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 27, 2026

Record last verified: 2016-12

Locations

FR (1)