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NCT Number: NCT04164576

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location contact

Armelle SCHULLER

SUB_INVESTIGATOR

Eva CHATRON

SUB_INVESTIGATOR

Floriane GALLAIS

SUB_INVESTIGATOR

Marianne RIOU

SUB_INVESTIGATOR

Michele PORZIO

SUB_INVESTIGATOR

Morgane SOLIS

SUB_INVESTIGATOR

Romain KESSLER

SUB_INVESTIGATOR

Samira FAFI-KREMER

CONTACT

[email protected]

+33 369551438

Samira FAFI-KREMER

PRINCIPAL_INVESTIGATOR

Sandrine HIRSCHI

SUB_INVESTIGATOR

Tristan DEGOT

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transplant patients

Genetic

Study the specific immunity against Polyomavirus

Primary outcomes

  1. BKV viral load in urine (viruria) and in plasma (viremia)

    Time frame: 3 years

    In cases of positive viral load, the viral genome will be sequenced to identify the replicative genotype.

Secondary outcomes

  1. Quantification of anti-BKV neutralizing antibodies

    Time frame: 3 years

Other outcomes

  1. Quantification of BKV specific T lymphocytes

    Time frame: 3 years

  2. TTV viral load in plasma

    Time frame: 3 years

    Evaluation of the viral load of TTV (reflection of global immunosuppression) or its genotype (established by sequencing).

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: BKV-Pneumo

Important dates

Study start
2020
Primary completion
2020
Study completion
2027
First posted
Nov 15, 2019
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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