Kidney TransplantationGARRENCT02147210
Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1
An observational study of Kidney Transplantation, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The principal purpose is the study of the regulation of the expression of ephrin-B1 by immunofluorescence in kidney biopsies of patients with Chronic transplant glomerulopathy (CTG) compared to biopsies prior to the CTG, in same patients. Level of fluorescence in CTG biopsy will be the experimental reference value. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- biological analysis
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Dec 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Biopsies from patients corresponding to eligibility criteria (see below) will be selected from the list of kidney transplant patients followed up in the Toulouse University Hospital. They will be divided into two groups matched for age, sex and time of kidney transplantation (n = 30 for each group). Iterative biopsies are conserved in the collection of tissue samples of the CHU
Who may be able to join
- Kidney transplant patient for whom renal biopsies are stored in the "collection of the University Hospital Toulouse" (collection N° DC-2009-989) and who received information on the purpose of the study, use of biopsies and who has not manifested any opposition.
- Kidney transplant patient with iterative biopsies with at least: post-surgery biopsy D0 (or early post-transplant biopsy D7 and at least one biopsy protocol. - Age> 18 years Case group: - Kidney transplant patient, followed up by "organ transplant unity" of CHU Toulouse, with antecedent of CMR progressing to CTG between 2006 and 2013. Control group: - Kidney transplant patient, followed up by "organ transplant unity" of CHU Toulouse, with antecedent of CMR without progressing to CTG between 2006 and 2013
Who cannot join
- patient with uncontrolled hypertension - patient with diabetes mellitus -
- patient treated or who was treated with mTOR inhibitor - recurrence of the initial glomerular pathology - de novo glomerulopathy - patient including in another study with an exclusion period still going
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Anatomie Pathologique et Histologie-Cytologie Hôpital Rangueil
Toulouse, 31059
About this study
The principal purpose is the study of the regulation of the expression of ephrin-B1 by immunofluorescence in kidney biopsies of patients with Chronic transplant glomerulopathy (CTG) compared to biopsies prior to the CTG, in same patients. Level of fluorescence in CTG biopsy will be the experimental reference value.
Read the detailed description
Chronic transplant glomerulopathy (CTG) is a specific lesion of kidney transplantation and a poor prognostic factor affecting transplant survival. Diagnosis remains only microscopic and lesions are irreversible. Recent studies prove that there is a strong correlation between CTG and antibody mediated rejection (AMR) with a possible link with chronic aggression of the endothelial cell. However, for unknown reason, all AMR does not lead to a CTG. Our recent data on mice demonstrated that ephrin-B1 is expressed in the glomerular endothelial cells and knockout mice for the gene encoding ephrin-B1 develop progressively ultrastructural glomerular lesions close to modifications observed in CTG, as well as proteinuria and chronic renal failure, suggesting that ephrin B1 could participate to CTG. Moreover, in a preliminary study on human kidney transplant biopsy we observed decrease in ephrin-B1 immunofluorescence on glomerulus when CTG, even in low grade. These data, and ultrastructural modifications in Knock Out (KO) mice suggest that early regulation of kidney expression of ephrin-B1 in the glomerulus may occur during the process leading to the CTG as antibody-mediated kidney rejection (AMR).
The purpose of the study is to determinate if ephrin-B1 expression is modified in CTG.
- Conditions
- Kidney Transplantation
- Being tested
- biological analysis
- Keywords
- Chronic transplant glomerulopathy, antibody mediated rejection, Ephrin-B1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological analysisOther
| Study group | Role | What they receive |
|---|---|---|
| 1-Case | patients who developed CTG secondary to antibody-mediated kidney rejection (AMR), diagnosed by microscopic analysis. Receives: Other: biological analysis | |
| 2-Control | patients with antibody-mediated kidney rejection (AMR) but without CTG Receives: Other: biological analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression level of ephrin-B1 in biopsies from kidney transplant
Analysis on all biopsies available from transplantation to Chronic transplant glomerulopathy by immunofluorescence (by anti-C4d)
Measured: Day 1
Secondary outcomes (2)
Level of expression of the gene encoding for ephrin-B1
Analysis on all biopsies available from transplantation to Chronic transplant glomerulopathy by quantitative PCR (qPCR) and normalized to the expression of the gene encoding for GAPDH
Measured: Day 1
Kinetics of expression of ephrin-B1
Analysis on all biopsies available from transplantation to CTG by quantitative PCR (qPCR) and normalized to the expression of the gene encoding for GAPDH
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 posted26 May 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline Guilbeau-Frugier, MD, Principal investigator, Service d'Anatomie Pathologique et Histologie-Cytologie,Rangueil Hospital, University Hospital of ToulouseJean-Michel Senard, Md PhD, Study director, Department of Pharmacology,Toulouse University Hospital and INSERM U1048
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147210
- Sponsor's protocol ID
- 13 194 02
- Other IDs
- AOL 2013
- Acronym
- GARRE
- Status last verified
- Mar 2017
- First submitted
- 19 May 2014
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1
- ClinicalTrials.gov ID
- NCT02147210
- Acronym / sponsor ID
- GARRE / 13 194 02
- Conditions
- Kidney Transplantation
- Keywords
- Chronic transplant glomerulopathy, antibody mediated rejection, Ephrin-B1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 May 2014 (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 principal purpose is the study of the regulation of the expression of ephrin-B1 by immunofluorescence in kidney biopsies of patients with Chronic transplant glomerulopathy (CTG) compared to biopsies prior to the CTG, in same patients. Level of fluorescence in CTG biopsy will be the experimental reference value.
Detailed description
Chronic transplant glomerulopathy (CTG) is a specific lesion of kidney transplantation and a poor prognostic factor affecting transplant survival. Diagnosis remains only microscopic and lesions are irreversible. Recent studies prove that there is a strong correlation between CTG and antibody mediated rejection (AMR) with a possible link with chronic aggression of the endothelial cell. However, for unknown reason, all AMR does not lead to a CTG. Our recent data on mice demonstrated that ephrin-B1 is expressed in the glomerular endothelial cells and knockout mice for the gene encoding ephrin-B1 develop progressively ultrastructural glomerular lesions close to modifications observed in CTG, as well as proteinuria and chronic renal failure, suggesting that ephrin B1 could participate to CTG. Moreover, in a preliminary study on human kidney transplant biopsy we observed decrease in ephrin-B1 immunofluorescence on glomerulus when CTG, even in low grade. These data, and ultrastructural modifications in Knock Out (KO) mice suggest that early regulation of kidney expression of ephrin-B1 in the glomerulus may occur during the process leading to the CTG as antibody-mediated kidney rejection (AMR).
The purpose of the study is to determinate if ephrin-B1 expression is modified in CTG.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Case | – | Other: biological analysispatients who developed CTG secondary to antibody-mediated kidney rejection (AMR), diagnosed by microscopic analysis. |
| 2-Control | – | Other: biological analysispatients with antibody-mediated kidney rejection (AMR) but without CTG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Biopsies from patients corresponding to eligibility criteria (see below) will be selected from the list of kidney transplant patients followed up in the Toulouse University Hospital. They will be divided into two groups matched for age, sex and time of kidney transplantation (n = 30 for each group). Iterative biopsies are conserved in the collection of tissue samples of the CHU
Key inclusion criteria (2 listed)
- Kidney transplant patient for whom renal biopsies are stored in the "collection of the University Hospital Toulouse" (collection N° DC-2009-989) and who received information on the purpose of the study, use of biopsies and who has not manifested any opposition.
- Kidney transplant patient with iterative biopsies with at least: post-surgery biopsy D0 (or early post-transplant biopsy D7 and at least one biopsy protocol. - Age> 18 years Case group: - Kidney transplant patient, followed up by "organ transplant unity" of CHU Toulouse, with antecedent of CMR progressing to CTG between 2006 and 2013. Control group: - Kidney transplant patient, followed up by "organ transplant unity" of CHU Toulouse, with antecedent of CMR without progressing to CTG between 2006 and 2013
Key exclusion criteria (2 listed)
- patient with uncontrolled hypertension - patient with diabetes mellitus -
- patient treated or who was treated with mTOR inhibitor - recurrence of the initial glomerular pathology - de novo glomerulopathy - patient including in another study with an exclusion period still going
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 |
|---|---|---|
| biological analysis | Other | 1-Case, 2-Control |
Primary outcome
Expression level of ephrin-B1 in biopsies from kidney transplant
Time frame: Day 1
Analysis on all biopsies available from transplantation to Chronic transplant glomerulopathy by immunofluorescence (by anti-C4d)
2 secondary outcomes
Level of expression of the gene encoding for ephrin-B1
Time frame: Day 1
Kinetics of expression of ephrin-B1
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 7 Mar 2017.
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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.
Céline Guilbeau-Frugier, MD principal investigator
Service d'Anatomie Pathologique et Histologie-Cytologie,Rangueil Hospital, University Hospital of Toulouse
Jean-Michel Senard, Md PhD study director
Department of Pharmacology,Toulouse University Hospital and INSERM U1048
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by University Hospital, Toulouse 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 2 inclusion and 2 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 7 Mar 2017. 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?
Expression level of ephrin-B1 in biopsies from kidney transplant (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2017.