BK Virus InfectionAcMBKNCT05264259
New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies
An observational study of BK Virus Infection, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
BK virus (BKV) infection has a major negative impact on transplant recipients. No BKV-specific antiviral therapy is available, so there is an urgent need to develop new anti-BKV preventive and therapeutic strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BK Virus Infection
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2022to 1 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Adult patient with a posititive serology BK confirmed
Who may be able to join
- BK positive
- adult
- ok to participed to research
Who cannot join
- under guardianship
- under curatorship
- opposed to research
- deprived of liberty
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Virologie - CHU Strasbourg - France
Strasbourg, 67091
Samira FAFI-KREMER, PUPH, 0369551438, samira.fafi-kremer@chru-strasbourg.fr
About this study
BK virus (BKV) infection has a major negative impact on transplant recipients. No BKV-specific antiviral therapy is available, so there is an urgent need to develop new anti-BKV preventive and therapeutic strategies.
- Conditions
- BK Virus Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the isolated monoclonal antibodies to neutralize all 3 BKV genotypes
The neutralization titer will be defined as the dilution of the sample that produced 50% inhibition of pseudovirion infectivity (IC50)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start5 Sep 2022
- Primary completion5 Sep 2022
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BK Virus InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samira FAFI-KREMER, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264259
- Sponsor's protocol ID
- 8521
- Acronym
- AcMBK
- Status last verified
- Aug 2025
- First submitted
- 7 Feb 2022
- Last updated
- 8 Aug 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 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies
- ClinicalTrials.gov ID
- NCT05264259
- Acronym / sponsor ID
- AcMBK / 8521
- Conditions
- BK Virus Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 3 Mar 2022 (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.
BK virus (BKV) infection has a major negative impact on transplant recipients. No BKV-specific antiviral therapy is available, so there is an urgent need to develop new anti-BKV preventive and therapeutic strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Adult patient with a posititive serology BK confirmed
Key inclusion criteria (3 listed)
- BK positive
- adult
- ok to participed to research
Key exclusion criteria (4 listed)
- under guardianship
- under curatorship
- opposed to research
- deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ability of the isolated monoclonal antibodies to neutralize all 3 BKV genotypes
Time frame: 5 years
The neutralization titer will be defined as the dilution of the sample that produced 50% inhibition of pseudovirion infectivity (IC50)
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 8 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for BK Virus Infection
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
EBV Viremia, CMV Viremia
Enrolling by invitationObservational study
ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
Kidney Diseases, Kidney Injury
Active, not recruitingPhase 2
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.
Samira FAFI-KREMER principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BK Virus Infection, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Anne-Sophie U GEY (+33 388116684, anne-sophie.gey@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of the isolated monoclonal antibodies to neutralize all 3 BKV genotypes (time frame: 5 years). 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 8 Aug 2025.