Blood sampling
OtherAt BKPyV reactivation, at 1 month, 3 months and 12 months
NCT Number: NCT06988072
The human pathogen BK polyomavirus (BKPyV) is a ubiquitous, small, non-enveloped DNA virus that infects over 90% of people, typically in childhood with mild or no symptoms. Following primary infection, BKPyV establishes latency predominantly in the reno-urinary tract, and can occasionally be detected in the urine without any concomitant clinical symptoms. However, among kidney transplant recipients (KTR), due to impaired cellular and humoral immunity, uncontrolled viral replication in renal tubular epithelial cells (RPTE) can occur, leading to high-level BKPyV DNAemia and significant damage to the reno-urinary system (ie polyomavirus-associated nephropathy). In the absence of any effective antiviral drug, the mainstay of therapy for significant BKPyV replication among KTR is reducing immunosuppressive drugs, despite the subsequent of risk of graft rejection. Current efforts to identify new monitoring and therapeutical strategies need to be supported by a better understanding of the dynamics of BKPyV-specific immune responses following transplantation.
Although adaptive cellular and humoral immune responses play a crucial role in the control of BKPyV reactivation among healthy individuals, immunosuppression and transplantation disrupt immune homeostasis and reshape the immune response landscape both in terms of function and fitness to new stimuli. Consequently, pre-transplant prediction of patients who will be able to control post-transplant BKPyV reactivation or who will develop BKPyV-related complications remains challenging. This knowledge gap stems from insufficient studies on the comprehensive analysis of immune responses during BKPyV reactivation. In particular, most studies to date have not investigated the role of NK cells in this context, despite their potent antiviral activity, heterogenous repertoire in each patient and their recently uncovered adaptive properties.
The hypothesis is that among KTR with de novo BKPyV DNAemia, the comprehensive analysis of anti-BKPyV immune responses (including both the description of NK cell repertoire and adaptive immune), could allow
* A better stratification of KTR at-risk for BKPyV-related complications using accessible immune biomarkers. * The identification of the most efficient strategies of immunosuppression management for the control of BKPyV DNAemia, that could be further evaluated in a prospective cohort. * The identification of immunological correlates for the control of BKPyV DNAemia, which aim at providing a foundation for the development of future immunotherapeutic strategies.
Trial opening soon.
Get Notified7 year and older
All sexes
Observational
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Additional criteria for kidney transplant recipients with BKPyV DNAemia:
Additional criteria for kidney transplant recipients without BKPyV DNAemia:
Additional criteria for healthy donors (controls):
Exclusion criteria
At BKPyV reactivation, at 1 month, 3 months and 12 months
Time frame: At inclusion
NK cells circulating repertoire defects associated with BKPyV-DNAemia Extensive characterization of the phenotype of circulating NK cells among kidney transplant recipients with de novo BKPyV DNAemia to predict the clinically relevant outcome "BKPyV reactivation control"
Time frame: At 1 month
NK cells circulating repertoire defects associated with BKPyV-DNAemia Extensive characterization of the phenotype of circulating NK cells among kidney transplant recipients with de novo BKPyV DNAemia to predict the clinically relevant outcome "BKPyV reactivation control"
Time frame: At 3 months
NK cells circulating repertoire defects associated with BKPyV-DNAemia Extensive characterization of the phenotype of circulating NK cells among kidney transplant recipients with de novo BKPyV DNAemia to predict the clinically relevant outcome "BKPyV reactivation control"
Time frame: At 12 months
NK cells circulating repertoire defects associated with BKPyV-DNAemia Extensive characterization of the phenotype of circulating NK cells among kidney transplant recipients with de novo BKPyV DNAemia to predict the clinically relevant outcome "BKPyV reactivation control"
Time frame: Up to 12 months
Cytotoxicity assays of NK cells in response to antigenic stimulation (pre-specified BKPyV peptides) and co-culture models (BKPyV-infected RPTEC) At each available timepoint
Time frame: Up to 12 months
Viral neutralization assays (humoral responses) and anti-BKPyV ELISPOT assays (T cell responses) At each available timepoint
Time frame: Up to 12 months
Correlation between the main changes in immunosuppressive treatment carried out after the appearance and BKPyV viremia and the anti-BKPyV immune response assessed by the immunological biomarkers
Time frame: Up to 12 months
Time frame: Up to 12 months
Time frame: Up to 12 months
Time frame: Up to 12 months
Whole genome sequencing (WGS) of BKPyV on consecutive plasma sample among patients with BKPyV DNAemia (characterization of major and minor viral subpopulations, identification of coinfections) At eaxh available timetpoint
Time frame: Up to 12 months
NK cells cytotoxicity assessments against allogenic endothelial cells after stimulation by BKPyV (infected cells and/or BKPyV isolated peptides)
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Official Title Étude Des réponses Immunes Anti-BKPyV Chez Les Patients transplantés rénaux Avec BKPyV virémie
Acronym: NEPHRO-BK
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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