Renal TransplantTHYMO BNCT02894606
Influence of Thymoglobuline on Phenotypic and Functional Profiles of B Lymphocytes in Renal Transplant Recipients
An observational study of Renal Transplant, run by University Hospital, Brest at 2 sites in France.
Trial summary
The investigators expect to better characterise B cell subpopulation and functional properties early after graft, to analyse effect of induction therapy (thymoglobulin versus basiliximab) on B cells, and to compare this B cell profiles with those obtained in our previous study in patients with chronic Antibody… 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?
- Thymoglobulin Induction and Basiliximab Induction
- How many people
- 49 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Feb 2015to 22 May 2018
- 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: kidney graft recipients from two French renal transplantation centers
Who may be able to join
- Age >18 years old
- Recipient of a renal allograft
- Patient receiving either basiliximab or thymoglobulin as in induction therapy for renal transplant
- Patient presenting a low immunologic risk
- Patient not opposed to his (her) study participation
Who cannot join
- Patient participating in a clinical trial
Trial locations and contacts
2 sites in 1 country.
About this study
The investigators expect to better characterise B cell subpopulation and functional properties early after graft, to analyse effect of induction therapy (thymoglobulin versus basiliximab) on B cells, and to compare this B cell profiles with those obtained in our previous study in patients with chronic Antibody Mediated Rejection (cAMR)
- Conditions
- Renal Transplant
- Being tested
- Thymoglobulin Induction, Basiliximab Induction
- Keywords
- Kidney Transplant, Immunology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymoglobulin InductionDrug
The choice of the induction therapy is not a procedure of the study. This choice is made by the practioner, based on the graft recipient profile. This is a predefined group, the Thymoglobulin treatment is not an intervention in the study but must be considered as an exposure that is defined before the patient enters the study.
Basiliximab InductionDrug
The choice of the induction therapy is not a procedure of the study. This choice is made by the practioner, based on the graft recipient profile. This is a predefined group, the Basiliximab treatment is not an intervention in the study but must be considered as an exposure that is defined before the patient enters the study.
| Study group | Role | What they receive |
|---|---|---|
| Thymoglobulin Induction | Patient receiving thymoglobulin as an induction therapy for renal transplant Receives: Drug: Thymoglobulin Induction | |
| Basiliximab Induction | Patient receiving basiliximab as an induction therapy for renal transplant Receives: Drug: Basiliximab Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The distribution of mature blood B cells subpopulations will be compared between the 2 groups
Measured: one year after renal transplant
Proliferation of freshly isolated cells T in presence of autologous B cells will be compared between the 2 groups.
Measured: one year after renal transplant
Secondary outcomes (1)
Serum B-cell activating factor (BAFF) concentration comparison between the two groups
Measured: one year after renal transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start9 Feb 2015
- Primary completion22 May 2018
- Study completion22 May 2018
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.
- More trials run by University Hospital, BrestThe 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
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yannick Le meur, Study director, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894606
- Sponsor's protocol ID
- THYMO B (RB 13.072)
- Acronym
- THYMO B
- 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
- Influence of Thymoglobuline on Phenotypic and Functional Profiles of B Lymphocytes in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT02894606
- Acronym / sponsor ID
- THYMO B / THYMO B (RB 13.072)
- Conditions
- Renal Transplant
- Keywords
- Kidney Transplant, Immunology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 9 Feb 2015 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 9 Sep 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 investigators expect to better characterise B cell subpopulation and functional properties early after graft, to analyse effect of induction therapy (thymoglobulin versus basiliximab) on B cells, and to compare this B cell profiles with those obtained in our previous study in patients with chronic Antibody Mediated Rejection (cAMR)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thymoglobulin Induction | – | Drug: Thymoglobulin InductionPatient receiving thymoglobulin as an induction therapy for renal transplant |
| Basiliximab Induction | – | Drug: Basiliximab InductionPatient receiving basiliximab as an induction therapy for renal transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- kidney graft recipients from two French renal transplantation centers
Key inclusion criteria (5 listed)
- Age >18 years old
- Recipient of a renal allograft
- Patient receiving either basiliximab or thymoglobulin as in induction therapy for renal transplant
- Patient presenting a low immunologic risk
- Patient not opposed to his (her) study participation
Key exclusion criteria (1 listed)
- Patient participating in a clinical trial
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 |
|---|---|---|
| Thymoglobulin InductionThe choice of the induction therapy is not a procedure of the study. This choice is made by the practioner, based on the graft recipient profile. This is a predefined group, the Thymoglobulin treatment is not an intervention in the study but must be considered as an exposure that is defined before the patient enters the study. | Drug | Thymoglobulin Induction |
| Basiliximab InductionThe choice of the induction therapy is not a procedure of the study. This choice is made by the practioner, based on the graft recipient profile. This is a predefined group, the Basiliximab treatment is not an intervention in the study but must be considered as an exposure that is defined before the patient enters the study. | Drug | Basiliximab Induction |
Primary outcome
The distribution of mature blood B cells subpopulations will be compared between the 2 groups
Time frame: one year after renal transplant
Proliferation of freshly isolated cells T in presence of autologous B cells will be compared between the 2 groups.
Time frame: one year after renal transplant
1 secondary outcome
Serum B-cell activating factor (BAFF) concentration comparison between the two groups
Time frame: one year after renal transplant
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 study director
University Hospital, Brest
2 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 2 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 5 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 2 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?
The distribution of mature blood B cells subpopulations will be compared between the 2 groups (time frame: one year after renal transplant). The study lists 2 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.