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Safety and efficacy of steering of immunosuppression based on BKPyV-specific T cells in case of BK Polyomavirus (BKPyV) DNAemia after kidney transplantation
EU CTIS ID: 2024-517219-56-00
What this study is testing
To demonstrate that not reducing immunosuppressive therapy (experimental group) is non-inferior to reducing immunosuppressive therapy according to standard of care guidelines (control group) with regard to the time to end of BKPyV-DNAemia for kidney transplanted patients diagnosed with BKPyV-DNAemia (≥ 10,000 IU/ml) and BKPyV-specific CD4 T cells ≥0.5 cells/µl.
- 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
- Kidney transplantation (also as part of multi-organ transplantations)
- BKPyV-DNAemia (≥ 10,000 IU/ml) and BKPyV-specific CD4 T cells ≥0.5 cells/µl.
- For women of childbearing potential (WCBP) (A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).): a negative serum pregnancy test with a sensitivity equal to at least 50 mIU/ml before study start and agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive method with a failure rate of <1% per year during the treatment period.
- For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.
- Signed Informed Consent: Patients’ guardians or adult patients who are capable of understanding the purpose and risks of the study must be willing to give written informed consent and willing to participate in and comply with the study protocol. Patients between 7 and 18 years have to agree with the study in addition to the informed consent of the legally authorized representative.
- Patients´ guardians or adult patients consent that in case of randomization to experimental arm change of IMP during study participation is not allowed.
You likely can't join if
- Pregnant or lactating women or intention of becoming pregnant during study treatment
- Criteria which in the opinion of the investigator preclude for reasons of compliance, or for reasons of the patient’s safety
- Subjects, who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
- Known hypersensitivity to any of IMP components which would interfere with IMP treatment
- The use of fluoroquinolones or statins to prevent or treat
- The use of cidofovir or leflunomide to treat BKPvV-DNAemia/-nephropathy
See the full eligibility criteria
- Kidney transplantation (also as part of multi-organ transplantations)
- BKPyV-DNAemia (≥ 10,000 IU/ml) and BKPyV-specific CD4 T cells ≥0.5 cells/µl.
- For women of childbearing potential (WCBP) (A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).): a negative serum pregnancy test with a sensitivity equal to at least 50 mIU/ml before study start and agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive method with a failure rate of <1% per year during the treatment period.
- For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.
- Signed Informed Consent: Patients’ guardians or adult patients who are capable of understanding the purpose and risks of the study must be willing to give written informed consent and willing to participate in and comply with the study protocol. Patients between 7 and 18 years have to agree with the study in addition to the informed consent of the legally authorized representative.
- Patients´ guardians or adult patients consent that in case of randomization to experimental arm change of IMP during study participation is not allowed.
- Current immunosuppression regime with at least one or a combination of defined IMP within this protocol.
- No change in immunosuppression regime within 4 weeks prior trial entry
- Pregnant or lactating women or intention of becoming pregnant during study treatment
- Criteria which in the opinion of the investigator preclude for reasons of compliance, or for reasons of the patient’s safety
- Subjects, who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
- Known hypersensitivity to any of IMP components which would interfere with IMP treatment
- The use of fluoroquinolones or statins to prevent or treat
- The use of cidofovir or leflunomide to treat BKPvV-DNAemia/-nephropathy
- Patients receiving belatacept who are seronegative for the Epstein-Barr virus (EBV) or whose serostatus is unknown
- Patients receiving azathioprine who meet any of the following conditions: o Suffering from a severe infection o Having significantly impaired liver or bone marrow function o Ongoing pancreatitis o Necessity to administer any live vaccine, particularly BCG, smallpox, or yellow fever
- Participation in another interventional trial
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, 18-64 years, 65+ years, 0-17 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.