Anti-BK Virus Immune Response and Kidney Transplantation
NCT ID: NCT01109186
Last Updated: 2021-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
158 participants
OBSERVATIONAL
2010-11-30
2015-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Renal Pretransplant Serology for BK Virus on the Risk of Post-transplant Viral Reactivation
NCT04506060
Evaluation of a Predictive Immunovirological Test Occurrence of BK Virus Nephropathy in Renal Transplant
NCT02049827
Study of the Serotype and Genotype of BK Virus in Kidney Transplant Recipients and Their Donors to Identify Individuals at Risk of Nephropathy
NCT07347769
Salivary Replication of BK Virus in Post-kidney Transplant
NCT07256470
Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients
NCT04164576
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
kidney-transplanted patients
biological parameters
blood sample at M1, M2, M3; M4; M5, M6, M7, M8 and M9 after kidney transplantation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
biological parameters
blood sample at M1, M2, M3; M4; M5, M6, M7, M8 and M9 after kidney transplantation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Older than 18 years old
* Treatment with tacrolimus and mycophénolate mofetil
Exclusion Criteria
* Pregnant women
* Patient under legal guardianship
* Treated by ciclosporin or mTOR-inhibitor
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nantes University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nantes' Univeristy hospital
Nantes, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BRD/10/03-ZF
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.