BK Virus NephropathyBKSEREINNCT04506060
Evaluation of Renal Pretransplant Serology for BK Virus on the Risk of Post-transplant Viral Reactivation
An observational study of BK Virus Nephropathy and Risk Factor, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Due to the increasing importance of BKV infection on the survival of kidney transplants, a better knowledge, in the pretransplant phase, of the risk factors leading to viral reactivation could allow the follow-up physician to be more vigilant and better prevent this pathology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BK Virus Nephropathy, Risk Factor, Kidney Transplantation
- What is being tested?
- serum withdrawal
- How many people
- 378 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Renal transplant patients with regular virological follow-up (blood and urine for BKV) during the first year after transplantation
Who may be able to join
- adult kidney transplanted patients
- Renal transplant patients with regular virological follow-up (blood and urine for BKV) during the first year after transplantation.
Who cannot join
- Renal transplant patients with no follow-up for one year after transplantation (transplant failure, return to dialysis, death, follow-up outside the transplant centre)
Trial locations and contacts
1 site in 1 country.
About this study
Due to the increasing importance of BKV infection on the survival of kidney transplants, a better knowledge, in the pretransplant phase, of the risk factors leading to viral reactivation could allow the follow-up physician to be more vigilant and better prevent this pathology. There are no commercial tests for BKV serology. In the virology laboratory, the investigators have developed the technique for producing "Virus-like particles" (VLP) that mimics the antigenic structure of the BK virus. The investigators plan to evaluate seroreactivity to the five BK virus serotypes in the recipient of a kidney transplant as a pretransplant and to compare this data with the detection or not of viral reactivation in the recipient during the first post-transplant year.
- Conditions
- BK Virus Nephropathy, Risk Factor, Kidney Transplantation
- Being tested
- serum withdrawal
- Keywords
- BK Virus Nephropathy, risk factor, kidney transplantation, viral serology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum withdrawalOther
Serum of the transplant patient. In the transplanted patient, the search for the BK virus is traditionally carried out during visits in the first year after transplantation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient
Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient. Optical density of serum antibody titer will be obtained by Elisa.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BK Virus NephropathyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506060
- Sponsor's protocol ID
- PI2020_843_0101
- Acronym
- BKSEREIN
- Status last verified
- Jun 2026
- First submitted
- 6 Aug 2020
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Renal Pretransplant Serology for BK Virus on the Risk of Post-transplant Viral Reactivation
- ClinicalTrials.gov ID
- NCT04506060
- Acronym / sponsor ID
- BKSEREIN / PI2020_843_0101
- Conditions
- BK Virus Nephropathy, Risk Factor, Kidney Transplantation
- Keywords
- BK Virus Nephropathy, risk factor, kidney transplantation, viral serology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 10 Aug 2020 (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.
Due to the increasing importance of BKV infection on the survival of kidney transplants, a better knowledge, in the pretransplant phase, of the risk factors leading to viral reactivation could allow the follow-up physician to be more vigilant and better prevent this pathology. There are no commercial tests for BKV serology. In the virology laboratory, the investigators have developed the technique for producing "Virus-like particles" (VLP) that mimics the antigenic structure of the BK virus. The investigators plan to evaluate seroreactivity to the five BK virus serotypes in the recipient of a kidney transplant as a pretransplant and to compare this data with the detection or not of viral reactivation in the recipient during the first post-transplant year.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal transplant patients with regular virological follow-up (blood and urine for BKV) during the first year after transplantation
Key inclusion criteria (2 listed)
- adult kidney transplanted patients
- Renal transplant patients with regular virological follow-up (blood and urine for BKV) during the first year after transplantation.
Key exclusion criteria (1 listed)
- Renal transplant patients with no follow-up for one year after transplantation (transplant failure, return to dialysis, death, follow-up outside the transplant centre)
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 |
|---|---|---|
| serum withdrawalSerum of the transplant patient. In the transplanted patient, the search for the BK virus is traditionally carried out during visits in the first year after transplantation. | Other | – |
Primary outcome
Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient
Time frame: one year
Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient. Optical density of serum antibody titer will be obtained by Elisa.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Nephropathy and Risk Factor, run by Centre Hospitalier Universitaire, Amiens 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 2 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: finished, as of the sponsor's last update on 24 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient (time frame: one year). 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 24 Jun 2026.