Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients

Not yet recruiting

• Conditions: Renal-urinary Impairment; Graft Rejection; Infection Episodes

• Registration Number: NCT04164576
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

BK virus (BKV) is a ubiquitous virus that infects more than 80% of the population. In case of immunosuppression, BKV can replicate and induce nephropathies in renal transplant recipients or haemorrhagic cystitis in bone marrow transplant recipients. The disruption of the balance between BKV replication and immune control is considered the key element in the development of these pathologies. During lung transplantation, patients undergo intense immunosuppression that favors the reactivation of persistent viruses such as EBV, CMV and probably BKV. Although the data on EBV and CMV reactivation are very clear and allow optimal management, the prevalence of BKV replication and its clinical impact in lung transplant recipients remains unknown at this time.

The aim of this study is to know the incidence and clinical impact of BKV replication in lung transplant recipients. Moreover, the results will help to better understand the interaction between the virus and his host, with a focus on the humoral and cellular immune response against BKV. The results could possibly enable to define predictive markers of BKV replication and of its evolution.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-12
• Last Update Submitted: 2019-11-12
• Study First Posted: 2019-11-15
• Last Update Posted: 2019-11-15
• Study Start: 2020-01
• Primary Completion: 2020-01
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BKV viral load in urine (viruria) and in plasma (viremia)	3 years	In cases of positive viral load, the viral genome will be sequenced to identify the replicative genotype.

Secondary Outcome Measures

Name	Time	Method
Quantification of anti-BKV neutralizing antibodies	3 years

Trial Locations

Locations (1)

Les Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France