Kidney Transplant RecipientsTRANSPLANTEETsNCT02555566
Role of Epoxyeicosatrienoic Acids in Chronic Allograft Nephropathy - The TRANSPLANT-EETs Study
A study testing Blood sampling and flow-mediated distal stimulation of the forearm radial artery by cutaneous heating in people with Kidney Transplant Recipients, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplant Recipients
- What is being tested?
- Blood sampling and flow-mediated distal stimulation of the forearm radial artery by cutaneous heating
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Liberty-deprived patient
- Pregnancy or absence of contraception in child-bearing aged women
- Patient enrolled in another research protocol within 2 weeks before inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Epoxyeicosatrienoic Acids in Chronic Allograft Nephropathy
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.
Read more
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
- Being tested
- Blood sampling, flow-mediated distal stimulation of the forearm radial artery by cutaneous heating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
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 heatingProcedure or surgery
Flow-mediated distal stimulation of the forearm radial artery by cutaneous heating for Kidney transplant recipients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood sampling; Procedure: flow-mediated distal stimulation of the forearm radial artery by cutaneous heating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 12 Months after transplantation
Secondary outcomes (11)
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]
Measured: 3 Months after transplantation
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]
Measured: 6 Months after transplantation
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]
Measured: 36 Months after transplantation
Difference between patients with specified polymorphisms and patients without in estimated Glomerular Filtration Rate (eGFR)
eGFR Scores range from 0 [kidney failure] to >90 [normal function]
Measured: 3 Months after transplantation
Difference between patients with specified polymorphisms and patients without in estimated Glomerular Filtration Rate (eGFR)
eGFR Scores range from 0 [kidney failure] to >90 [normal function]
Measured: 6 Months after transplantation
Difference between patients with specified polymorphisms and patients without in estimated Glomerular Filtration Rate (eGFR)
eGFR Scores range from 0 [kidney failure] to >90 [normal function]
Measured: 12 Months after transplantation
Difference between patients with specified polymorphisms and patients without in estimated Glomerular Filtration Rate (eGFR)
eGFR Scores range from 0 [kidney failure] to >90 [normal function]
Measured: 36 Months after transplantation
Difference between blood EETs concentration at baseline and after distal cutaneous heating for patients with the specified polymorphisms.
EEts plasma concentration is measured using liquid chromatography coupled to tandem mass spectrometry before and after distal cutaneous heating. Unit is ng per mL
Measured: Day 1
Difference between blood EETs concentration at baseline and after distal cutaneous heating for patients without the specified polymorphisms.
EEts plasma concentration is measured using liquid chromatography coupled to tandem mass spectrometry before and after distal cutaneous heating. Unit is ng per mL
Measured: Day 1
Difference between variation of diameter of the forearm radial artery after distal cutaneous heating for patients with the specified polymorphisms.
Variation of diameter of the radial artery is measured in millimeter.
Measured: Day 1
Difference between variation of diameter of the forearm radial artery after distal cutaneous heating for patients without the specified polymorphisms.
Variation of diameter of the radial artery is measured in millimeter.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startMar 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique GUERROT, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555566
- Sponsor's protocol ID
- 2013/150/HP
- Acronym
- TRANSPLANTEETs
- Status last verified
- Dec 2016
- First submitted
- 17 Sep 2015
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33580125
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Epoxyeicosatrienoic Acids in Chronic Allograft Nephropathy
- ClinicalTrials.gov ID
- NCT02555566
- Acronym / sponsor ID
- TRANSPLANTEETs / 2013/150/HP
- Conditions
- Kidney Transplant Recipients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients | Experimental | Procedure: Blood sampling, Procedure: flow-mediated distal stimulation of the forearm radial artery by cutaneous heatingblood 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sampling is done for Kidney transplant recipients for evaluation of the polymorphisms and EETs dosage | Procedure or surgery | Kidney transplant recipients |
| flow-mediated distal stimulation of the forearm radial artery by cutaneous heatingFlow-mediated distal stimulation of the forearm radial artery by cutaneous heating for Kidney transplant recipients | Procedure or surgery | Kidney transplant recipients |
Primary outcome
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]
11 secondary outcomes
Difference between patients with the EPHX2 Lys55Arg polymorphism and patients without in estimated Glomerular Filtration Rate (eGFR)
Time frame: 3 Months after transplantation
Difference between patients with the EPHX2 Lys55Arg polymorphism and patients without in estimated Glomerular Filtration Rate (eGFR)
Time frame: 6 Months after transplantation
Difference between patients with the EPHX2 Lys55Arg polymorphism and patients without in estimated Glomerular Filtration Rate (eGFR)
Time frame: 36 Months after transplantation
Difference between patients with specified polymorphisms and patients without in estimated Glomerular Filtration Rate (eGFR)
Time frame: 3 Months after transplantation
Difference between patients with specified polymorphisms and patients without in estimated Glomerular Filtration Rate (eGFR)
Time frame: 6 Months after transplantation
Difference between patients with specified polymorphisms and patients without in estimated Glomerular Filtration Rate (eGFR)
Time frame: 12 Months after transplantation
Difference between patients with specified polymorphisms and patients without in estimated Glomerular Filtration Rate (eGFR)
Time frame: 36 Months after transplantation
Difference between blood EETs concentration at baseline and after distal cutaneous heating for patients with the specified polymorphisms.
Time frame: Day 1
Difference between blood EETs concentration at baseline and after distal cutaneous heating for patients without the specified polymorphisms.
Time frame: Day 1
Difference between variation of diameter of the forearm radial artery after distal cutaneous heating for patients with the specified polymorphisms.
Time frame: Day 1
Difference between variation of diameter of the forearm radial artery after distal cutaneous heating for patients without the specified polymorphisms.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Results publication: PubMed 33580125Duflot 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.
Related trials for Kidney Transplant Recipients
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
Not yet recruitingPhase 2/3
Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus
Kidney Transplant Recipient
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique GUERROT, Pr principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and flow-mediated distal stimulation of the forearm radial artery by cutaneous heating in people with Kidney Transplant Recipients, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between patients with the EPHX2 Lys55Arg polymorphism and patients without in estimated Glomerular Filtration Rate (eGFR) (time frame: 12 Months after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02555566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.