Disorder Related to Renal TransplantationORLY-EstNCT02843867
Orientation of the Lymphocyte Response to the Occurrence of Atherosclerotic Complications After Kidney Transplantation
An observational study of Disorder Related to Renal Transplantation, run by Centre Hospitalier Universitaire de Besancon at 7 sites in France.
Trial summary
The incidence of atherosclerotic complications is increased after kidney transplantation. Traditional risk factors do not fully explain this increased risk. Atherosclerosis is an inflammatory disease in which all players in the immune response are involved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder Related to Renal Transplantation
- What is being tested?
- blood sample
- How many people
- 1,150 participants
- Where
- 7 sitesFrance
- Study dates
- 28 Nov 2008to 23 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population corresponds to 1000 patients receiving a renal transplant in Hospital of Besançon, Dijon, Nancy, Reims, Clermont-Ferrand, Strasbourg et Kremlin-Bicêtre.
Who may be able to join
- Male or female patients aged over 18 years
- Patients receiving a renal transplant
- Patients able to understand the benefits and risks of testing
- Patients gave written informed consent.
Who cannot join
- Inability to understand the advantages and disadvantages of the study; psychiatric disorders judged by the investigator to be incompatible with the inclusion in the study.
- Immunosuppressive therapy immediately prior to transplantation
- Cancer (except skin cancer) or malignant blood disease being treated; active infection; decompensated cirrhosis [patients had cancer and considered as cured or in remission, patients with virus infection of hepatitis B or hepatitis C and having no cirrhosis may be included].
- This study is strictly non-interventional, participation in another study is not a cons-indication to the inclusion in this study and no exclusion period is required for inclusion in another study after inclusion in this study (Art L. 1121-12 (loi n°2004-806 du 9 Août 2004).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU de Besançon
Besançon, 25000
CHU Clermont-Ferrand, 58 rue Montalembert, 63003 Clermont-Ferrand
Clermont-Ferrand, 63003
CHU Dijon, Hôpital du Bocage, 2 Bd du Maréchal de Lattre de Tassigny, 21079 Dijon cedex
Dijon, 21079
Hôpital du Kremlin Bicêtre 78, rue du Général Leclerc, 94275 Le Kremlin-Bicêtre Cedex
Le Kremlin-Bicêtre, 94275
CHU Brabois, et Vandoeuvre les Nancy
Nancy
CHU Reims, 45 rue Cognacq-Jay 51092 Reims Cedex
Reims, 51092
Hôpital Civil- 1, place de l'hôpital BP426 ; 67091 Strasbourg Cedex
Strasbourg, 67091
About this study
Official title: Influence de l'ORientation de la réponse LYmphocytaire Sur la Survenue de Complications athéromateuses après Transplantation rénale (étude ORLY-EST 2)
The incidence of atherosclerotic complications is increased after kidney transplantation. Traditional risk factors do not fully explain this increased risk. Atherosclerosis is an inflammatory disease in which all players in the immune response are involved. The impact of these immune responses is not well known in immunocompromised patients, particularly among organ transplant. Nevertheless, the work of our group suggest that innate and acquired responses through different mechanisms influencing the evolution of atheromatous disease after transplantation.
The investigators therefore propose to study the impact of the expansion of regulatory T cells on the risk of atherosclerotic complications after transplantation.
Read more
Since November 2008, the investigators began a multicenter, prospective study whose purpose is to study in detail the immunological mechanisms of atherosclerosis after transplantation via immunomonitoring cohort of renal transplant patients in the Grand East Interregion. It was planned to include 500 patients and to date a little more than half have been included. After completion of the blood test, the tubes are routed over the Biomonitoring Platform (CIC-BT 506 Besançon) and the samples are stored in CRB Dijon.
The atherosclerotic events are recorded prospectively. The investigators hope to implement as part of ORLY IS, a second study to determine the impact of an expansion of regulatory T cells on the risk of atherosclerotic events.
Our hypothesis is that a cell rate regulatory T below the median results in an increase of 5% of atherosclerotic complications.
- Being tested
- blood sample
- Keywords
- Transplantation, Immunology, Atherosclerosis
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
36 ml of blood sample at D0 and 1 year after transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of regulatory T cells related to atherosclerotic complications events.
Percentage of regulatory T cells
Measured: 5 or 10 years
Secondary outcomes (2)
Atherosclerotic complications events
Percentage of regulatory T cells
Measured: 5 or 10 years
Genetic determinants (TNF-alpha, IL-6,...) related to cardiovascular events
Percentage of regulatory T cells
Measured: 5 or 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start28 Nov 2008
- Primary completion23 Oct 2020
- Study completion23 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disorder Related to Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- University of Franche-Comté, Etablissement Français du Sang
- Responsible party
- Sponsor
- Investigators
- Didier Ducloux, Pr., Principal investigator, CHRU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843867
- Sponsor's protocol ID
- R/2011/44
- Acronym
- ORLY-Est
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2016
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Identified individual participant data for all outcome measures will be made available within 6 monts of study completion
Publications
Ducloux D, Courivaud C, Bamoulid J, Crepin T, Gaiffe E, Laheurte C, Vauchy C, Rebibou JM, Saas P, Borot S. Immune phenotype predicts new onset diabetes after kidney transplantation. Hum Immunol. 2019 Nov;80(11):937-942. doi: 10.1016/j.humimm.2019.08.006. Epub 2019 Sep 10.
PubMed 31515130Ducloux D, Legendre M, Bamoulid J, Rebibou JM, Saas P, Courivaud C, Crepin T. ESRD-associated immune phenotype depends on dialysis modality and iron status: clinical implications. Immun Ageing. 2018 Jul 17;15:16. doi: 10.1186/s12979-018-0121-z. eCollection 2018.
PubMed 30026783
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence de l'ORientation de la réponse LYmphocytaire Sur la Survenue de Complications athéromateuses après Transplantation rénale (étude ORLY-EST 2)
- ClinicalTrials.gov ID
- NCT02843867
- Acronym / sponsor ID
- ORLY-Est / R/2011/44
- Keywords
- Transplantation, Immunology, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- University of Franche-Comté, Etablissement Français du Sang
- Study start
- 28 Nov 2008 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2030 (estimated)
- First posted
- 26 Jul 2016 (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.
The incidence of atherosclerotic complications is increased after kidney transplantation. Traditional risk factors do not fully explain this increased risk. Atherosclerosis is an inflammatory disease in which all players in the immune response are involved. The impact of these immune responses is not well known in immunocompromised patients, particularly among organ transplant. Nevertheless, the work of our group suggest that innate and acquired responses through different mechanisms influencing the evolution of atheromatous disease after transplantation.
The investigators therefore propose to study the impact of the expansion of regulatory T cells on the risk of atherosclerotic complications after transplantation.
Since November 2008, the investigators began a multicenter, prospective study whose purpose is to study in detail the immunological mechanisms of atherosclerosis after transplantation via immunomonitoring cohort of renal transplant patients in the Grand East Interregion. It was planned to include 500 patients and to date a little more than half have been included. After completion of the blood test, the tubes are routed over the Biomonitoring Platform (CIC-BT 506 Besançon) and the samples are stored in CRB Dijon.
The atherosclerotic events are recorded prospectively. The investigators hope to implement as part of ORLY IS, a second study to determine the impact of an expansion of regulatory T cells on the risk of atherosclerotic events.
Our hypothesis is that a cell rate regulatory T below the median results in an increase of 5% of atherosclerotic complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population corresponds to 1000 patients receiving a renal transplant in Hospital of Besançon, Dijon, Nancy, Reims, Clermont-Ferrand, Strasbourg et Kremlin-Bicêtre.
Key inclusion criteria (4 listed)
- Male or female patients aged over 18 years
- Patients receiving a renal transplant
- Patients able to understand the benefits and risks of testing
- Patients gave written informed consent.
Key exclusion criteria (4 listed)
- Inability to understand the advantages and disadvantages of the study; psychiatric disorders judged by the investigator to be incompatible with the inclusion in the study.
- Immunosuppressive therapy immediately prior to transplantation
- Cancer (except skin cancer) or malignant blood disease being treated; active infection; decompensated cirrhosis [patients had cancer and considered as cured or in remission, patients with virus infection of hepatitis B or hepatitis C and having no cirrhosis may be included].
- This study is strictly non-interventional, participation in another study is not a cons-indication to the inclusion in this study and no exclusion period is required for inclusion in another study after inclusion in this study (Art L. 1121-12 (loi n°2004-806 du 9 Août 2004).
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 sample36 ml of blood sample at D0 and 1 year after transplantation | Other | – |
Primary outcome
Percentage of regulatory T cells related to atherosclerotic complications events.
Time frame: 5 or 10 years
Percentage of regulatory T cells
2 secondary outcomes
Atherosclerotic complications events
Time frame: 5 or 10 years
Genetic determinants (TNF-alpha, IL-6,...) related to cardiovascular events
Time frame: 5 or 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Derived from this study: PubMed 31515130Ducloux D, Courivaud C, Bamoulid J, Crepin T, Gaiffe E, Laheurte C, Vauchy C, Rebibou JM, Saas P, Borot S. Immune phenotype predicts new onset diabetes after kidney transplantation. Hum Immunol. 2019 Nov;80(11):937-942. doi: 10.1016/j.humimm.2019.08.006. Epub 2019 Sep 10.
- Derived from this study: PubMed 30026783Ducloux D, Legendre M, Bamoulid J, Rebibou JM, Saas P, Courivaud C, Crepin T. ESRD-associated immune phenotype depends on dialysis modality and iron status: clinical implications. Immun Ageing. 2018 Jul 17;15:16. doi: 10.1186/s12979-018-0121-z. eCollection 2018.
- Individual participant dataSharing planned: Yes. Identified individual participant data for all outcome measures will be made available within 6 monts of study completion
Related trials for Disorder Related to Renal Transplantation
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
Active, not recruitingPhase 2
Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients
Human Papillomavirus Infection, Human Papillomavirus-Related Carcinoma
RecruitingPhase 2
Safety and Tolerability of IDO-1 Inhibition in the Prevention of EBV-related Pathology in EBV Negative Kidney Transplant Recipients Receiving an Organ From EBV Positive Donors
EBV Infections, Kidney Transplant
Active, not recruiting
Curcumin in Kidney Transplant Recipients
Disorder Related to Renal Transplantation
Active, not recruitingObservational study
Proteinuria and Renal Perfusion in Renal Transplant Recipients
Pre-kidney Transplant, Living Donor Kidney Transplantation
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.
Didier Ducloux, Pr. principal investigator
CHRU de Besançon
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder Related to Renal Transplantation, run by Centre Hospitalier Universitaire de Besancon at 7 sites 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of regulatory T cells related to atherosclerotic complications events. (time frame: 5 or 10 years). 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 NCT02843867, which also lists 2 linked publications.
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 3 Aug 2022.