DSA Intragraft in Lung Transplantation: Diagnostic and Prognostic Value in Antibody Mediated Rejection

Antibody Mediated Rejection Clinical Trial

Official title:

Intérêt Diagnostique et Pronostique de la présence d'Anticorps spécifiques du Donneur Intra-greffon Dans le Rejet Humoral en Transplantation Pulmonaire

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03702257
• Other study ID #: 7039
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2019
• Est. completion date: February 22, 2026

Study information

• Verified date: February 2022
• Source: University Hospital, Strasbourg, France
• Contact: Sandrine HIRSCHI
• Phone: +33 3 69 55 11 78
• Email: sandrine.hirschi[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The diagnosis of AMR in lung transplant recipients is difficult and often comes too late, because of lack of standardized definition. The diagnosis is nowadays based on an expert multidisciplinary approach involving clinical, histopathological and immunological criteria. Hypothesis: the presence of intragraft donor specific antibodies (gDSAs) could be used as a new diagnostic tool for AMR in lung transplant recipients Study Objectives: to evaluate, in lung transplant patients with circulating DSAs, the diagnostic value of gDSAs in AMR and to analyze its prognostic value on graft outcome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 22, 2026
• Est. primary completion date: February 22, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patient older than 18 years
• Transplanted pulmonary or cardiopulmonary patient
• And developing circulating anti-HLA antibodies directed against the graft or "DSA" at a threshold > 1000 of MFI in the 30 days preceding the inclusion visit
• Affiliation to the French social security
• Patient able to understand the objectives and risks related to research and to give informed, dated and signed consent

Exclusion criteria:

• Patient whose anti-HLA antibodies are not directed against the graft (no DSA)
• Contraindication to performing a bronchial fibroscopy with transbronchial biopsies
• Treatment with intravenous immunoglobulin (less than 1 month before inclusion) or Rituximab (less than 6 months before inclusion)
• Plasma exchanges (less than 3 months before inclusion)
• Risk of bleeding predictable (crushing disorder, impossibility of stopping the offending treatments)
• Impossibility of giving the subject informed information
• Subject under the protection of justice Subject under guardianship or curatorship
• Pregnancy
• Breastfeeding

Related Conditions & MeSH terms

• Antibody Mediated Rejection
• Donor Specific Antibodies
• Lung Transplant Recipient

Intervention

Procedure:
• bronchoscopy.
gDSAs are studied on cryopreserved biopsies obtained during bronchoscopy. The technique is the one described by Visentin J.

Locations

Country	Name	City	State
France	Hôpital Marie Lannelongue	Le Plessis Robinson
France	CHU Nord	Marseille
France	Hôpital Bichat	Paris
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of AMR	Sensitivity and specificity of the presence of gDSA for the diagnosis of AMR in lung transplant recipients with circulating DSA, as established by an expert pathologist panel and in accordance with recent international recommendations	2 years
Secondary	Comparaison in gDSA+ vs gDSAs- patients	Incidence of graft loss	2 years