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Evaluation and promotion of specific adaptative immunity against polyomavirus (BKV) to prevent viral infection after kidney transplantation (BK-VAX project)
EU CTIS ID: 2023-504309-35-00
What this study is testing
to evaluate the role of adaptive immunity against to BKV and its modulation according to different immunosuppressive regimens used routinely in kidney transplantation, including mTor-i drugs.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The patient must be at least 18 years old.
- The patient must be able to give informed consent in writing
- Patient receiving a kidney transplant.
- The patient must have a maintenance immunosuppressive regimen based on tacrolimus + MMF/MPS + corticosteroids or tacrolimus + rapamycin + corticosteroids.
- Patient with viral load detectable by PCR in peripheral blood against the BK-virus
- Kidney transplant patient at Vall d'Hebron Hospital at most 12 months before viral load detection.
You likely can't join if
- Prior diagnosis of T cell-mediated or antibody-mediated rejection.
- Active cancer excluding non-melanocytic skin cancer
- Potentially Fertile Women who do not agree to use measures reliable contraceptives during the trial, who are pregnant, in period of breast-feeding or who present a positive pregnancy test at the time of their inclusion in the study
- Patients presenting with another severe systemic infection at the time of randomization.
- Patients with positive HIV serology
See the full eligibility criteria
- The patient must be at least 18 years old.
- The patient must be able to give informed consent in writing
- Patient receiving a kidney transplant.
- The patient must have a maintenance immunosuppressive regimen based on tacrolimus + MMF/MPS + corticosteroids or tacrolimus + rapamycin + corticosteroids.
- Patient with viral load detectable by PCR in peripheral blood against the BK-virus
- Kidney transplant patient at Vall d'Hebron Hospital at most 12 months before viral load detection.
- Stable renal function with an estimated glomerular filtration rate ≥ 35 ml/min/1.73 m2
- Urine protein/creatinine ratio value less than 1 g/g
- Prior diagnosis of T cell-mediated or antibody-mediated rejection.
- Active cancer excluding non-melanocytic skin cancer
- Potentially Fertile Women who do not agree to use measures reliable contraceptives during the trial, who are pregnant, in period of breast-feeding or who present a positive pregnancy test at the time of their inclusion in the study
- Patients presenting with another severe systemic infection at the time of randomization.
- Patients with positive HIV serology
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.