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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04164576
Acronym
BKV-Pneumo
Enrollment
120
Registered
2019-11-15
Start date
2020-01-31
Completion date
2027-06-30
Last updated
2019-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Rejection, Infection Episodes, Renal-urinary Impairment

Keywords

Lung transplantation, BKV, Nephropathy, Immunosuppression

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.

Interventions

GENETICTransplant patients

Study the specific immunity against Polyomavirus

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Lung transplant recipients in Strasbourg University Hospital between 30 June 2018 and 31 December 2022 * Male or female patients, age over 18 years * Patient having provided informed written consent to take part in the study * Patient affiliated to Social Security

Exclusion criteria

* Patient deprived of liberty, by judicial or administrative decision * Patient under legal guardianship * Impossibility to give complete information about this study to the patient

Design outcomes

Primary

MeasureTime frameDescription
BKV viral load in urine (viruria) and in plasma (viremia)3 yearsIn cases of positive viral load, the viral genome will be sequenced to identify the replicative genotype.

Secondary

MeasureTime frame
Quantification of anti-BKV neutralizing antibodies3 years

Other

MeasureTime frameDescription
Quantification of BKV specific T lymphocytes3 years
TTV viral load in plasma3 yearsEvaluation of the viral load of TTV (reflection of global immunosuppression) or its genotype (established by sequencing).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026