BK PolyomavirusNEPHRO-BKNCT06988072
Study of Anti-BKPyV Immune Responses in Kidney Transplant Patients With BKPyV Viremia
An observational study of BK Polyomavirus and Kidney Transplant, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- BK Polyomavirus, Kidney Transplant
- What is being tested?
- blood sampling
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2025to 30 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study population: kidney transplant recipients with de novo BKPyV DNAemia within the first 12 months post-transplantation, including adult and pediatric patients. Control subjects: control subjects will be matched to the study patients (criteria below with a ratio of 1-1-1): * Healthy adult donors from the National blood bak (Etablissement Français du Sang - EFS): these control patients will be matched to study population patients on age (± 5ans) and sex * Kidney transplant recipients without BKPyV DNAemia, enrolled within the active cohorts of the participating centers: these control patients will be matched to study population patients on age (± 5ans), enrolling center, time since transplantation (± 3 months), and sex.
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- Objection to participation in the research study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Official Title Étude Des réponses Immunes Anti-BKPyV Chez Les Patients transplantés rénaux Avec BKPyV virémie
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.
Read more
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.
- Conditions
- BK Polyomavirus, Kidney Transplant
- Being tested
- blood sampling
- Keywords
- Polyomavirus hominis 1, Natural killer cells, T-lymphocytes, Neutralizing antibodies, Adaptative immunity, Immunologic memory, Innate immunity recognition, Trained immunity, Immune repertoire, Biomarkers, BKPyV-association nephropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
At BKPyV reactivation, at 1 month, 3 months and 12 months
blood samplingOther
once
blood samplingOther
once
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant recipients with de novo BKPyV DNAemia | kidney transplant recipients with de novo BKPyV DNAemia within the first 12 months post-transplantation, including adult and pediatric patients Receives: Other: blood sampling | |
| Control subjects : Healthy adult donors from the National blood bak | Not described Receives: Other: blood sampling | |
| Control subjects : Kidney transplant recipients without BKPyV DNAemia | Not described Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of circulating NK cells
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"
Measured: At inclusion
Number of circulating NK cells
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"
Measured: At 1 month
Number of circulating NK cells
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"
Measured: At 3 months
Number of circulating NK cells
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"
Measured: At 12 months
Secondary outcomes (8)
Frequency of Functional Impact of BKPyV Reactivation on NK Cell Effector Functions
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
Measured: Up to 12 months
Frequency of T- and B-cell specific functional responses in patients with de novo BKPyV reactivation
Viral neutralization assays (humoral responses) and anti-BKPyV ELISPOT assays (T cell responses) At each available timepoint
Measured: Up to 12 months
Correlation between the main changes in immunosuppressive treatment and the anti-BPyV immune response
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
Measured: Up to 12 months
Correlation between the main changes in immunosuppressive treatment and the control of BKPyV viremia
Measured: Up to 12 months
Correlation between the main changes in immunosuppressive treatment and the occurrence of BKPyV nephropathy
Measured: Up to 12 months
Correlation between the main changes in immunosuppressive treatment and the occurrence of rejection
Measured: Up to 12 months
BKPyV viral diversity evolution during clinical course of infection
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
Measured: Up to 12 months
Impact of BKPyV reactivation on alloreactive properties of NK cells
NK cells cytotoxicity assessments against allogenic endothelial cells after stimulation by BKPyV (infected cells and/or BKPyV isolated peptides)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start30 May 2025 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BK PolyomavirusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988072
- Sponsor's protocol ID
- APHP241147
- Acronym
- NEPHRO-BK
- Status last verified
- May 2025
- First submitted
- 4 Apr 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Official Title Étude Des réponses Immunes Anti-BKPyV Chez Les Patients transplantés rénaux Avec BKPyV virémie
- ClinicalTrials.gov ID
- NCT06988072
- Acronym / sponsor ID
- NEPHRO-BK / APHP241147
- Conditions
- BK Polyomavirus, Kidney Transplant
- Keywords
- Polyomavirus hominis 1, Natural killer cells, T-lymphocytes, Neutralizing antibodies, Adaptative immunity, Immunologic memory, Innate immunity recognition, Trained immunity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients with de novo BKPyV DNAemia | – | Other: blood samplingkidney transplant recipients with de novo BKPyV DNAemia within the first 12 months post-transplantation, including adult and pediatric patients |
| Control subjects : Healthy adult donors from the National blood bak | – | Other: blood sampling |
| Control subjects : Kidney transplant recipients without BKPyV DNAemia | – | Other: blood sampling |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population: kidney transplant recipients with de novo BKPyV DNAemia within the first 12 months post-transplantation, including adult and pediatric patients. Control subjects: control subjects will be matched to the study patients (criteria below with a ratio of 1-1-1): * Healthy adult donors from the National blood bak (Etablissement Français du Sang - EFS): these control patients will be matched to study population patients on age (± 5ans) and sex * Kidney transplant recipients without BKPyV DNAemia, enrolled within the active cohorts of the participating centers: these control patients will be matched to study population patients on age (± 5ans), enrolling center, time since transplantation (± 3 months), and sex.
Key inclusion criteria (14 listed)
- 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
- Patients who underwent kidney transplantation within 12 months prior to inclusion, regardless of the initial indication
Key exclusion criteria (1 listed)
- Objection to participation in the research study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingAt BKPyV reactivation, at 1 month, 3 months and 12 months | Other | Kidney transplant recipients with de novo BKPyV DNAemia |
| blood samplingonce | Other | Control subjects : Healthy adult donors from the National blood bak |
| blood samplingonce | Other | Control subjects : Kidney transplant recipients without BKPyV DNAemia |
Primary outcome
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"
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"
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"
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"
8 secondary outcomes
Frequency of Functional Impact of BKPyV Reactivation on NK Cell Effector Functions
Time frame: Up to 12 months
Frequency of T- and B-cell specific functional responses in patients with de novo BKPyV reactivation
Time frame: Up to 12 months
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 and the control of BKPyV viremia
Time frame: Up to 12 months
Correlation between the main changes in immunosuppressive treatment and the occurrence of BKPyV nephropathy
Time frame: Up to 12 months
Correlation between the main changes in immunosuppressive treatment and the occurrence of rejection
Time frame: Up to 12 months
BKPyV viral diversity evolution during clinical course of infection
Time frame: Up to 12 months
Impact of BKPyV reactivation on alloreactive properties of NK cells
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for BK Polyomavirus
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
BK Virus Infection, BKV Infection
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
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Enrolling by invitationObservational study
ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
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Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis
Transplantation Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of BK Polyomavirus and Kidney Transplant, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien Gras, MD (+33142494991 ext. +33, julien.gras@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of circulating NK cells (time frame: At inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.