Kidney TransplantationBKvNCT01109186
Anti-BK Virus Immune Response and Kidney Transplantation
An observational study of Kidney Transplantation, run by Nantes University Hospital at 1 site in France.
Trial summary
BK virus infections are very frequent during months following a kidney transplantation: a viral reactivation is observed for almost 50% of patients during first year. This reactivation leads to a viremia for 10 to 15% of patient during this same period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- biological parameters
- How many people
- 158 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2010to 1 Sep 2015
- 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: Kidney-transplanted person
Who may be able to join
- Kidney-transplanted patient, since less than 30 days
- Older than 18 years old
- Treatment with tacrolimus and mycophénolate mofetil
Who cannot join
- No informed consent
- Pregnant women
- Patient under legal guardianship
- Treated by ciclosporin or mTOR-inhibitor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Specific Immune Cellular Response in the Control of BK Virus Infection: Prospective Study, Monocentric and Longitudinal During the First Nine Months After a Kidney Transplantation
BK virus infections are very frequent during months following a kidney transplantation: a viral reactivation is observed for almost 50% of patients during first year. This reactivation leads to a viremia for 10 to 15% of patient during this same period. The most frequent complication is interstitial nephritis for 2 to 8% of patients (27 patients representing 2.7% during 6 years in Nantes).
An intensive et persisting viral replication, assessed by detection of high blood viral load, could evolved to a viral nephropathy which lead to a very pejorative functional issue for the graft.
Read more
Biological follow-up of these infections lay on the measures of viral load. Their positivity must alert the physician and lead him to modulate immunosuppressive treatment.
Actually, there is no real consensus about the modalities of pharmacological immunosuppression decrease (decrease dose or change of molecule).
Specific lymphocytic anti-BKv evaluated on several cohorts of patients permit to prove:
- weakness of immune cellular response for patient with high viremia
- increase of this response when viral load decrease These studies laid on detection of INFg synthesis by Elispot after stimulation with viral antigens and in vitro cellular expansion.
New prospective and longitudinal data comparing the immune cellular response (systematic and early) after graft between patients controlling or not BKv infection are necessary to improve the comprehension of illness natural history.
The investigators propose to enlarge the investigation of anti-BKv immune cellular response to other functions than IFNg synthesis in the aim of detecting the eventual role of polyfunctional lymphocytes for infection control. Furthermore, the investigators propose to identify better diagnostic and prognostic makers.
- Conditions
- Kidney Transplantation
- Being tested
- biological parameters
- Keywords
- patient with a kidney transplantation since less than 30 days
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological parametersOther
blood sample at M1, M2, M3; M4; M5, M6, M7, M8 and M9 after kidney transplantation
| Study group | Role | What they receive |
|---|---|---|
| kidney-transplanted patients | Not described Receives: Other: biological parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the level of response between patient with a "non-controlled infection" and patients for who the blood viral load is under 103 copBKv/ml.
Analyse the role of T-lymphocytes response in the control of BKv infection
Measured: at 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantation
Secondary outcomes (3)
Analyse of the other causes that could influence the occurence of a viremia higher than 103 copBKv/ml
Other causes for abnormal viremia
Measured: at 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantation
Measurement of histological consequences of a BKv non-controlled infection during the first year post-graft
Determine the frequence of occurence of nephropathy due to BKv for the population with a non-controlled infection
Measured: at 12 months after kidney transplantation
Measurement of increase of immune response due to modifications of immunosuppressive treatment for patient with a non-controlled infection
Comparision between the level of immune response and the time when the first viremia is higher than 103 copBKv/ml and 1, 3 et 6 months after modification of immunosuppressive treatment.
Measured: at 1, 3 et 6 months after modification of immunosuppressive treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study start30 Nov 2010
- Primary completion26 Aug 2014
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109186
- Sponsor's protocol ID
- BRD/10/03-ZF
- Acronym
- BKv
- Status last verified
- Sep 2021
- First submitted
- 21 Apr 2010
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Specific Immune Cellular Response in the Control of BK Virus Infection: Prospective Study, Monocentric and Longitudinal During the First Nine Months After a Kidney Transplantation
- ClinicalTrials.gov ID
- NCT01109186
- Acronym / sponsor ID
- BKv / BRD/10/03-ZF
- Conditions
- Kidney Transplantation
- Keywords
- patient with a kidney transplantation since less than 30 days
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 30 Nov 2010 (actual)
- Primary completion
- 26 Aug 2014 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 23 Apr 2010 (estimated)
- 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 infections are very frequent during months following a kidney transplantation: a viral reactivation is observed for almost 50% of patients during first year. This reactivation leads to a viremia for 10 to 15% of patient during this same period. The most frequent complication is interstitial nephritis for 2 to 8% of patients (27 patients representing 2.7% during 6 years in Nantes).
An intensive et persisting viral replication, assessed by detection of high blood viral load, could evolved to a viral nephropathy which lead to a very pejorative functional issue for the graft.
Biological follow-up of these infections lay on the measures of viral load. Their positivity must alert the physician and lead him to modulate immunosuppressive treatment.
Actually, there is no real consensus about the modalities of pharmacological immunosuppression decrease (decrease dose or change of molecule).
Specific lymphocytic anti-BKv evaluated on several cohorts of patients permit to prove:
- weakness of immune cellular response for patient with high viremia
- increase of this response when viral load decrease These studies laid on detection of INFg synthesis by Elispot after stimulation with viral antigens and in vitro cellular expansion.
New prospective and longitudinal data comparing the immune cellular response (systematic and early) after graft between patients controlling or not BKv infection are necessary to improve the comprehension of illness natural history.
The investigators propose to enlarge the investigation of anti-BKv immune cellular response to other functions than IFNg synthesis in the aim of detecting the eventual role of polyfunctional lymphocytes for infection control. Furthermore, the investigators propose to identify better diagnostic and prognostic makers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| kidney-transplanted patients | – | Other: biological parameters |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney-transplanted person
Key inclusion criteria (3 listed)
- Kidney-transplanted patient, since less than 30 days
- Older than 18 years old
- Treatment with tacrolimus and mycophénolate mofetil
Key exclusion criteria (4 listed)
- No informed consent
- Pregnant women
- Patient under legal guardianship
- Treated by ciclosporin or mTOR-inhibitor
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 |
|---|---|---|
| biological parametersblood sample at M1, M2, M3; M4; M5, M6, M7, M8 and M9 after kidney transplantation | Other | kidney-transplanted patients |
Primary outcome
Comparison of the level of response between patient with a "non-controlled infection" and patients for who the blood viral load is under 103 copBKv/ml.
Time frame: at 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantation
Analyse the role of T-lymphocytes response in the control of BKv infection
3 secondary outcomes
Analyse of the other causes that could influence the occurence of a viremia higher than 103 copBKv/ml
Time frame: at 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantation
Measurement of histological consequences of a BKv non-controlled infection during the first year post-graft
Time frame: at 12 months after kidney transplantation
Measurement of increase of immune response due to modifications of immunosuppressive treatment for patient with a non-controlled infection
Time frame: at 1, 3 et 6 months after modification of immunosuppressive treatment
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 17 Sep 2021.
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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 Kidney Transplantation, run by Nantes University Hospital 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: finished, as of the sponsor's last update on 17 Sep 2021. 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?
Comparison of the level of response between patient with a "non-controlled infection" and patients for who the blood viral load is under 103 copBKv/ml. (time frame: at 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantation). 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 17 Sep 2021.