NCT03016455

Brief 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). The functional analysis will help to better understand B cell-dependant mechanisms implied in T cell proliferation and better target future treatments.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 4, 2017

Status Verified

April 1, 2017

Enrollment Period

4.5 years

First QC Date

August 30, 2016

Last Update Submit

May 2, 2017

Conditions

Renal Transplant

Keywords

Kidney TransplantImmunology

Outcome Measures

Primary Outcomes (4)

  • Evaluation of the ratio (percentage and absolute values) of mature LB subpopulations (LBm1 to LBm5) and of memory LB by specific labellings

    At the inclusion day

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

    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

    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.

    At the inclusion day

Secondary Outcomes (2)

  • Correlation between phenotypic and functional evaluations, and clinical outcome

    One year post inclusion

  • comparison of the B cell subpopulations before and after rituximab treatment

    One year post inclusion

Study Arms (3)

DSA positive patients without cAMR

Presence of DSA w/o cAMR

Other: Presence of DSA w/o cAMR

DSA positive patients with cAMR

Presence of DSA w/ cAMR

Other: Presence of DSA w/ cAMR

Stable patients

No DSA No cAMR

Other: No DSA No cAMR

Interventions

Presence of DSA w/ cAMROTHER
DSA positive patients with cAMR
Presence of DSA w/o cAMROTHER
DSA positive patients without cAMR
No DSA No cAMROTHER
Stable patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • \- Patients that has not signed the consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

CHU Amiens

Amiens, 80054, France

COMPLETED

Chu Angers

Angers, 49933, France

COMPLETED

CHU Brest

Brest, 29200, France

RECRUITING

CHU CAEN

Caen, 14033, France

COMPLETED

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

COMPLETED

CHU Limoges

Limoges, 87042, France

WITHDRAWN

APHP Hôpital Necker

Paris, 75743, France

COMPLETED

CHU Poitiers

Poitiers, 86021, France

COMPLETED

CHU Reims

Reims, 51092, France

COMPLETED

CHU Rennes

Rennes, 35033, France

COMPLETED

CHU Rouen

Rouen, 76230, France

COMPLETED

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

COMPLETED

CHU Tours

Tours, 37044, France

COMPLETED

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Interventions

2-methyl-3-hydroxybutyryl-coenzyme A dehydrogenase

Study Officials

  • Yannick LE MEUR, MD PhD

    University Hospital, Brest

    STUDY DIRECTOR

Central Study Contacts

Yannick LE MEUR, MD PhD

CONTACT

yannick.lemeur@chu-brest.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2016

First Posted

January 10, 2017

Study Start

June 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 4, 2017

Record last verified: 2017-04

Locations

FR(13)