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NCT Number: NCT06988072

Study of Anti-BKPyV Immune Responses in Kidney Transplant Patients With BKPyV Viremia

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.

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Key information

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • No objection to participation in the research study (from patients or legal guardians)
  • Affiliated to the French national social security system
  • Age ≥ 7 years old
  • Weight ≥ 12 kg

Additional criteria for kidney transplant recipients with BKPyV DNAemia:

  • Patients who underwent kidney transplantation within 12 months prior to inclusion, regardless of the initial indication
  • Detectable de novo BKPyV DNAemia within the first 12 months post-transplantation

Additional criteria for kidney transplant recipients without BKPyV DNAemia:

  • Patients who underwent kidney transplantation within 12 months prior to inclusion, regardless of the initial indication
  • No detectable de novo BKPyV DNAemia within the first 12 months post-transplantation

Additional criteria for healthy donors (controls):

  • Age ≥ 18 years old
  • Blood donation to the EFS
  • Consent for the use of their blood donation for research purposes.

Exclusion criteria

  • Objection to participation in the research study

Treatment and study plan

Blood sampling

Other

At BKPyV reactivation, at 1 month, 3 months and 12 months

Primary outcomes

  1. Number of circulating NK cells

    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"

  2. Number of circulating NK cells

    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"

  3. Number of circulating NK cells

    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"

  4. Number of circulating NK cells

    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"

Secondary outcomes

  1. Frequency of Functional Impact of BKPyV Reactivation on NK Cell Effector Functions

    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

  2. Frequency of T- and B-cell specific functional responses in patients with de novo BKPyV reactivation

    Time frame: Up to 12 months

    Viral neutralization assays (humoral responses) and anti-BKPyV ELISPOT assays (T cell responses) At each available timepoint

  3. Correlation between the main changes in immunosuppressive treatment and the anti-BPyV immune response

    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

  4. Correlation between the main changes in immunosuppressive treatment and the control of BKPyV viremia

    Time frame: Up to 12 months

  5. Correlation between the main changes in immunosuppressive treatment and the occurrence of BKPyV nephropathy

    Time frame: Up to 12 months

  6. Correlation between the main changes in immunosuppressive treatment and the occurrence of rejection

    Time frame: Up to 12 months

  7. BKPyV viral diversity evolution during clinical course of infection

    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

  8. Impact of BKPyV reactivation on alloreactive properties of NK cells

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Julien Gras, MD

CONTACT

[email protected]

+33142494991 ext. +33

Jérôme Lambert, MD PhD

CONTACT

[email protected]

+33142499742 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Official Title Étude Des réponses Immunes Anti-BKPyV Chez Les Patients transplantés rénaux Avec BKPyV virémie

Acronym: NEPHRO-BK

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 23, 2025
Registry last updated
May 23, 2025

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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