Renal TransplantBHLNCT03016455
B Cell Lymphocyte in Humoral Rejection and Alloimmunisation
An observational study of Renal Transplant, run by University Hospital, Brest at 13 sites in France.
Trial summary
This study aims to better characterise B cell phenotype and functional abnormalities in kidney transplant patients producing donor specific antibody (DSA) and in those with chronic antibody mediated rejection (cAMR) and to search for a predictive tool (biomarker). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant
- What is being tested?
- Presence of DSA w/ cAMR, Presence of DSA w/o cAMR and No DSA No cAMR
- How many people
- 116 participants
- Where
- 13 sitesFrance
- Study dates
- 13 Jun 2013to 12 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: 100 kidney graft recipients with DSA or cAMR (renal dysfunction, positive DSA, allograft nephropathy), and 25 stable patients of 13 French transplantation centres.
Who may be able to join
- Non stable patients :
- Patient older than 18 years old.
- Patient which is the recipient of a renal transplant
- Patient who develops anti donor antibodies after the transplantation and / or suffering from a histologically-proven antibody mediated rejection.
- Patient who has signed an informed consent form
- Stable patients :
Show all 11Show fewer
- Patient older than 18 years old.
- Patient that is the recipient of a renal transplant for more than one year
- Patient who has accepted to participate in the Brest Kidney graft recipient collection
- Patient that is not suffering from any rejection, that has a good renal function and a low proteinuria
- Patient that has not developed any DSA.
Who cannot join
- Patients that has not signed the consent form.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CHU Amiens
Amiens, 80054
Chu Angers
Angers, 49933
CHU Brest
Brest, 29200
CHU CAEN
Caen, 14033
Chu Clermont Ferrand
Clermont-Ferrand, 63003
CHU Limoges
Limoges, 87042
APHP Hôpital Necker
Paris, 75743
CHU Poitiers
Poitiers, 86021
CHU Reims
Reims, 51092
CHU Rennes
Rennes, 35033
CHU Rouen
Rouen, 76230
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
CHU Tours
Tours, 37044
About this study
This study aims to better characterise B cell phenotype and functional abnormalities in kidney transplant patients producing donor specific antibody (DSA) and in those with chronic antibody mediated rejection (cAMR) and to search for a predictive tool (biomarker). The functional analysis will help to better understand B cell-dependant mechanisms implied in T cell proliferation and better target future treatments.
Read the detailed description
The principal objective is to better understand the B cell dependant mechanisms of the chronic antibody mediated rejection (cAMR). A particular focus will be done on the mechanisms that could explain the natural history of chronic humoral mediated rejection and of pathways from DSA negative status toward DSA positive status and from DSA positive status to histological lesions. The following will be undergone for three categories of patients (stable patients, DSA positive patients without cAMR and DSA positive patients with cAMR) :
- A phenotypic analysis of B cells of patients suffering from chronic humoral rejection or who are simply DSA positive.
- A functional analysis in autologous cultures in order to confirm our preliminary results.
- A functional analysis in a heterologous proliferation test aiming at a better understanding of the absence of B cell regulation of T cell proliferation in patients suffering from cAMR.
- A cytokine analysis (IL10, alpha-tumor necrosis factor, gamma-interferon dosing), for a better understanding of the mechanisms that are involved in the regulation of the T cell response that is induced by the B cells.
- Conditions
- Renal Transplant
- Being tested
- Presence of DSA w/ cAMR, Presence of DSA w/o cAMR, No DSA No cAMR
- Keywords
- Kidney Transplant, Immunology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presence of DSA w/ cAMROther
Presence of DSA w/o cAMROther
No DSA No cAMROther
| Study group | Role | What they receive |
|---|---|---|
| DSA positive patients without cAMR | Presence of DSA w/o cAMR Receives: Other: Presence of DSA w/o cAMR | |
| DSA positive patients with cAMR | Presence of DSA w/ cAMR Receives: Other: Presence of DSA w/ cAMR | |
| Stable patients | No DSA No cAMR Receives: Other: No DSA No cAMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the ratio (percentage and absolute values) of mature LB subpopulations (LBm1 to LBm5) and of memory LB by specific labellings
Measured: At the inclusion day
Evaluation of the proliferation of freshly isolated cells T in presence of autologous B cells
Measured: At the inclusion day
Evaluation of the proliferation of T cells in a heterologous test
aiming at a better understanding of the absence of B cell regulation of T cell proliferation in patients suffering from cAMR
Measured: At the inclusion day
cytokine analysis(IL10, alpha-Tumor Necrosis FActor, gamma-Interferon dosing)
for a better understanding of the mechanisms that are involved in the regulation of the T cell response that is induced by the B cells.
Measured: At the inclusion day
Secondary outcomes (2)
Correlation between phenotypic and functional evaluations, and clinical outcome
Measured: One year post inclusion
comparison of the B cell subpopulations before and after rituximab treatment
In a subgroup of patients, the ones that will happen to be treated by rituximab for a rejection episode.
Measured: One year post inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start13 Jun 2013
- Primary completion12 Dec 2016
- Study completion12 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yannick LE MEUR, MD PhD, Study director, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016455
- Sponsor's protocol ID
- BHL (RB 12.047)
- Acronym
- BHL
- Status last verified
- Jun 2026
- First submitted
- 30 Aug 2016
- Last updated
- 8 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B Cell Lymphocyte in Humoral Rejection and Alloimmunisation
- ClinicalTrials.gov ID
- NCT03016455
- Acronym / sponsor ID
- BHL / BHL (RB 12.047)
- Conditions
- Renal Transplant
- Keywords
- Kidney Transplant, Immunology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 13 Jun 2013 (actual)
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 12 Dec 2016 (actual)
- First posted
- 10 Jan 2017 (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.
This study aims to better characterise B cell phenotype and functional abnormalities in kidney transplant patients producing donor specific antibody (DSA) and in those with chronic antibody mediated rejection (cAMR) and to search for a predictive tool (biomarker). The functional analysis will help to better understand B cell-dependant mechanisms implied in T cell proliferation and better target future treatments.
Detailed description
The principal objective is to better understand the B cell dependant mechanisms of the chronic antibody mediated rejection (cAMR). A particular focus will be done on the mechanisms that could explain the natural history of chronic humoral mediated rejection and of pathways from DSA negative status toward DSA positive status and from DSA positive status to histological lesions. The following will be undergone for three categories of patients (stable patients, DSA positive patients without cAMR and DSA positive patients with cAMR) :
- A phenotypic analysis of B cells of patients suffering from chronic humoral rejection or who are simply DSA positive.
- A functional analysis in autologous cultures in order to confirm our preliminary results.
- A functional analysis in a heterologous proliferation test aiming at a better understanding of the absence of B cell regulation of T cell proliferation in patients suffering from cAMR.
- A cytokine analysis (IL10, alpha-tumor necrosis factor, gamma-interferon dosing), for a better understanding of the mechanisms that are involved in the regulation of the T cell response that is induced by the B cells.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DSA positive patients without cAMR | – | Other: Presence of DSA w/o cAMRPresence of DSA w/o cAMR |
| DSA positive patients with cAMR | – | Other: Presence of DSA w/ cAMRPresence of DSA w/ cAMR |
| Stable patients | – | Other: No DSA No cAMRNo DSA No cAMR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 kidney graft recipients with DSA or cAMR (renal dysfunction, positive DSA, allograft nephropathy), and 25 stable patients of 13 French transplantation centres.
Key inclusion criteria (11 listed)
- Non stable patients :
- Stable patients :
Key exclusion criteria (1 listed)
- Patients that has not signed the consent form.
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 |
|---|---|---|
| Presence of DSA w/ cAMR | Other | DSA positive patients with cAMR |
| Presence of DSA w/o cAMR | Other | DSA positive patients without cAMR |
| No DSA No cAMR | Other | Stable patients |
Primary outcome
Evaluation of the ratio (percentage and absolute values) of mature LB subpopulations (LBm1 to LBm5) and of memory LB by specific labellings
Time frame: At the inclusion day
Evaluation of the proliferation of freshly isolated cells T in presence of autologous B cells
Time frame: At the inclusion day
Evaluation of the proliferation of T cells in a heterologous test
Time frame: At the inclusion day
aiming at a better understanding of the absence of B cell regulation of T cell proliferation in patients suffering from cAMR
cytokine analysis(IL10, alpha-Tumor Necrosis FActor, gamma-Interferon dosing)
Time frame: At the inclusion day
for a better understanding of the mechanisms that are involved in the regulation of the T cell response that is induced by the B cells.
2 secondary outcomes
Correlation between phenotypic and functional evaluations, and clinical outcome
Time frame: One year post inclusion
comparison of the B cell subpopulations before and after rituximab treatment
Time frame: One year post inclusion
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 8 Jun 2026.
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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.
Yannick LE MEUR, MD PhD study director
University Hospital, Brest
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplant, run by University Hospital, Brest at 13 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 11 inclusion and 1 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
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?
Evaluation of the ratio (percentage and absolute values) of mature LB subpopulations (LBm1 to LBm5) and of memory LB by specific labellings (time frame: At the inclusion day). The study lists 4 primary outcomes in all. 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 8 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.