NCT03438058

Brief Summary

This project will involve a systematic literature review and meta-analysis of studies assessing the impact of complement-activating anti-Human Leukocyte Antigen (HLA) donor specific antibodies (DSA) on the allograft survival rate and on the rejection rate. This meta-analysis will assess the role of complement activating anti-HLA DSAs across the entire transplant field including kidney, liver, lung and heart transplant recipient's studies.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
7,547

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Status
completed

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

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

February 1, 2018

Last Update Submit

February 15, 2018

Conditions

Organ Transplant Recipients

Keywords

Solid Organ TransplantationGraft survivalRejectionComplement-activating anti-HLA DSAMeta-analysisPrognosis

Outcome Measures

Primary Outcomes (1)

  • Allograft Survival rate

    To assess the impact of complement-activating anti-Human Leukocyte Antigen (HLA) donor specific antibodies (DSA) on the allograft survival rate in solid organ transplant patients (Heart, Kidney, Lung, Liver and Small Bowel transplant recipients)

    death censored allograft survival at minimum 1 year of follow up

Secondary Outcomes (1)

  • Allograft Rejection rate

    rejection rate during follow up (at minimum 3 months post transplantation) or rejection defined by biopsy at inclusion

Study Arms (3)

With complement-activating anti-HLA DSAs

Patients with complement-activating anti-HLA DSAs either C1q, C3d, C4d and IgG subclass

Other: Graft survival and/or Rejection appearance

Without complement-activating anti-HLA DSAs

Patients with anti-HLA DSAs but without the ability to activate the complement (either C1q, C3d, C4d and IgG subclass)

Other: Graft survival and/or Rejection appearance

Without DSAs and without complement-activating DSAs

Matching group of patients without DSAs and without complement-activating DSAs

Other: Graft survival and/or Rejection appearance

Interventions

Graft survival and/or Rejection appearanceOTHER
With complement-activating anti-HLA DSAsWithout DSAs and without complement-activating DSAsWithout complement-activating anti-HLA DSAs

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The eligible studies include all solid organ transplant patients (kidney, liver, lung, heart, and intestinal transplantation), both adult or paediatric patients in which complement-activating anti-HLA DSAs have been measured (either C1q, C3d, and C4d or their IgG3 subclass). In those studies data on allograft survival and rejection rate have to be measure.

You may qualify if:

  • Study design:
  • Studies of any relevant design and in any language on the impact of complement-activating anti-HLA DSAs on long-term graft survival and/or the risk of rejection will be initially selected.
  • eligible studies: The eligible studies include all solid organ transplant patients (kidney, liver, lung, heart, and intestinal transplantation), both adult or paediatric patients.
  • Measurement:
  • Anti-HLA DSAs detect by the single antigen Luminex bead technique (SAB) will be required for the DSA detection technique. Complement-activating anti-HLA DSAs will be defined according to their ability to bind C1q, C3d, and C4d or their IgG3 subclass.

You may not qualify if:

  • Animal studies
  • Ex vivo studies
  • Methodological studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bouquegneau A, Loheac C, Aubert O, Bouatou Y, Viglietti D, Empana JP, Ulloa C, Murad MH, Legendre C, Glotz D, Jackson AM, Zeevi A, Schaub S, Taupin JL, Reed EF, Friedewald JJ, Tyan DB, Susal C, Shapiro R, Woodle ES, Hidalgo LG, O'Leary J, Montgomery RA, Kobashigawa J, Jouven X, Jabre P, Lefaucheur C, Loupy A. Complement-activating donor-specific anti-HLA antibodies and solid organ transplant survival: A systematic review and meta-analysis. PLoS Med. 2018 May 25;15(5):e1002572. doi: 10.1371/journal.pmed.1002572. eCollection 2018 May.

    PMID: 29799874DERIVED

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Carmen Lefaucheur, PhD

    Paris Translational Research Center for Organ Transplantation

    PRINCIPAL INVESTIGATOR

  • Alexandre Loupy, PhD

    Paris Translational Research Center for Organ Transplantation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Alexandre Loupy

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 19, 2018

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

February 1, 2018

Last Updated

February 19, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

No access to the individual participant data