Renal-urinary ImpairmentBKV-PneumoNCT04164576
Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients
An observational study of Renal-urinary Impairment and Graft Rejection, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
BK virus (BKV) is a ubiquitous virus that infects more than 80% of the population. In case of immunosuppression, BKV can replicate and induce nephropathies in renal transplant recipients or haemorrhagic cystitis in bone marrow transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal-urinary Impairment, Graft Rejection, Infection Episodes
- What is being tested?
- Transplant patients
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2020to Jun 2027
- 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: Lung transplant recipients between 30 June 2018 and 31 December 2022 at the University Hospital of Strasbourg
Who may be able to join
- Lung transplant recipients in Strasbourg University Hospital between 30 June 2018 and 31 December 2022
- Male or female patients, age over 18 years
- Patient having provided informed written consent to take part in the study
- Patient affiliated to Social Security
Who cannot join
- Patient deprived of liberty, by judicial or administrative decision
- Patient under legal guardianship
- Impossibility to give complete information about this study to the patient
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
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Samira FAFI-KREMER, +33 369551438, samira.fafi-kremer@chru-strasbourg.fr
Samira FAFI-KREMER
About this study
BK virus (BKV) is a ubiquitous virus that infects more than 80% of the population. In case of immunosuppression, BKV can replicate and induce nephropathies in renal transplant recipients or haemorrhagic cystitis in bone marrow transplant recipients. The disruption of the balance between BKV replication and immune control is considered the key element in the development of these pathologies. During lung transplantation, patients undergo intense immunosuppression that favors the reactivation of persistent viruses such as EBV, CMV and probably BKV. Although the data on EBV and CMV reactivation are very clear and allow optimal management, the prevalence of BKV replication and its clinical impact in lung transplant recipients remains unknown at this time.
The aim of this study is to know the incidence and clinical impact of BKV replication in lung transplant recipients. Moreover, the results will help to better understand the interaction between the virus and his host, with a focus on the humoral and cellular immune response against BKV. The results could possibly enable to define predictive markers of BKV replication and of its evolution.
- Being tested
- Transplant patients
- Keywords
- Lung transplantation, BKV, Nephropathy, Immunosuppression
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplant patientsGenetic
Study the specific immunity against Polyomavirus
What is being measured
The primary outcome is the main question the study is designed to answer.
BKV viral load in urine (viruria) and in plasma (viremia)
In cases of positive viral load, the viral genome will be sequenced to identify the replicative genotype.
Measured: 3 years
Secondary outcomes (1)
Quantification of anti-BKV neutralizing antibodies
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study startJan 2020 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal-urinary ImpairmentStudies 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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164576
- Sponsor's protocol ID
- 7547
- Acronym
- BKV-Pneumo
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2019
- Last updated
- 15 Nov 2019
- 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 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT04164576
- Acronym / sponsor ID
- BKV-Pneumo / 7547
- Keywords
- Lung transplantation, BKV, Nephropathy, Immunosuppression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Nov 2019 (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) is a ubiquitous virus that infects more than 80% of the population. In case of immunosuppression, BKV can replicate and induce nephropathies in renal transplant recipients or haemorrhagic cystitis in bone marrow transplant recipients. The disruption of the balance between BKV replication and immune control is considered the key element in the development of these pathologies. During lung transplantation, patients undergo intense immunosuppression that favors the reactivation of persistent viruses such as EBV, CMV and probably BKV. Although the data on EBV and CMV reactivation are very clear and allow optimal management, the prevalence of BKV replication and its clinical impact in lung transplant recipients remains unknown at this time.
The aim of this study is to know the incidence and clinical impact of BKV replication in lung transplant recipients. Moreover, the results will help to better understand the interaction between the virus and his host, with a focus on the humoral and cellular immune response against BKV. The results could possibly enable to define predictive markers of BKV replication and of its evolution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung transplant recipients between 30 June 2018 and 31 December 2022 at the University Hospital of Strasbourg
Key inclusion criteria (4 listed)
- Lung transplant recipients in Strasbourg University Hospital between 30 June 2018 and 31 December 2022
- Male or female patients, age over 18 years
- Patient having provided informed written consent to take part in the study
- Patient affiliated to Social Security
Key exclusion criteria (3 listed)
- Patient deprived of liberty, by judicial or administrative decision
- Patient under legal guardianship
- Impossibility to give complete information about this study to the patient
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 |
|---|---|---|
| Transplant patientsStudy the specific immunity against Polyomavirus | Genetic | – |
Primary outcome
BKV viral load in urine (viruria) and in plasma (viremia)
Time frame: 3 years
In cases of positive viral load, the viral genome will be sequenced to identify the replicative genotype.
1 secondary outcome
Quantification of anti-BKV neutralizing antibodies
Time frame: 3 years
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 15 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Les Hôpitaux Universitaires de Strasbourg
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 Renal-urinary Impairment and Graft Rejection, 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 4 inclusion and 3 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 15 Nov 2019. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BKV viral load in urine (viruria) and in plasma (viremia) (time frame: 3 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 15 Nov 2019.