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Completed

NCT Number: NCT03016455

B Cell Lymphocyte in Humoral Rejection and Alloimmunisation

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 :
  • 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.

Exclusion criteria

  • Patients that has not signed the consent form.

Treatment and study plan

Presence of DSA w/ cAMR

Other

Presence of DSA w/o cAMR

Other

No DSA No cAMR

Other

Primary outcomes

  1. 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

  2. Evaluation of the proliferation of freshly isolated cells T in presence of autologous B cells

    Time frame: At the inclusion day

  3. 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

  4. 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.

Secondary outcomes

  1. Correlation between phenotypic and functional evaluations, and clinical outcome

    Time frame: One year post inclusion

  2. comparison of the B cell subpopulations before and after rituximab treatment

    Time frame: One year post inclusion

    In a subgroup of patients, the ones that will happen to be treated by rituximab for a rejection episode.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: BHL

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 10, 2017
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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