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Immunosuppression regimen reduction in kidney transplantation recipients admitted to the intensive care unit in the setting of septic shock and/or acute respiratory failure: an open multicentric randomized phase IV study
EU CTIS ID: 2024-518493-14-00
What this study is testing
To evaluate the effectiveness of a strategy of reduction in the level of immunosuppressive treatments to improve organ(s) failure(s) at day 5.
- Phase II and Phase III (Integrated)
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
- Adult patients, aged 18 years-old and over
- Kidney transplant recipients, with transplantation occurring more than 3 months prior to ICU admission
- Patients admitted to the ICU in the setting of: o Septic shock (sepsis requiring vasopressor support, with or without hyperlactatemia), o And/or acute respiratory failure of presumed infectious origin (invasive or non-invasive ventilation, FiO2 greater than or equal to 50%),
- Patients treated with at least an immunosuppressive bitherapy (including steroids, calcineurin inhibitors, mTOR inhibitors, azathioprine, or mycophenolate mofetil),
- Patients affiliated with a social health insurance protection scheme
- Patients able of understanding the objectives and risks related to the research and providing a dated and signed informed consent. If patient is unable to consent: consent from relatives will be searched, and if absent, an emergency procedure will be process
You likely can't join if
- Minor patients
- Patients unable to consent: under legal protection measures, patients deprived of liberty
- Kidney transplant recipients treated with Belatacept due to the persistent effect of Belatacept, it is not possible to modulate this treatment in a short term period
- Patients with severe chronic graft dysfunction (glomerular filtration rate < 20 ml/min/1.73m² according to the CKD-EPI formula in the month prior to admission
- Transplant renal recipients who have already resumed RRT (hemodialysis or peritoneal dialysis),
- Multi-organ transplant recipients
See the full eligibility criteria
- Adult patients, aged 18 years-old and over
- Kidney transplant recipients, with transplantation occurring more than 3 months prior to ICU admission
- Patients admitted to the ICU in the setting of: o Septic shock (sepsis requiring vasopressor support, with or without hyperlactatemia), o And/or acute respiratory failure of presumed infectious origin (invasive or non-invasive ventilation, FiO2 greater than or equal to 50%),
- Patients treated with at least an immunosuppressive bitherapy (including steroids, calcineurin inhibitors, mTOR inhibitors, azathioprine, or mycophenolate mofetil),
- Patients affiliated with a social health insurance protection scheme
- Patients able of understanding the objectives and risks related to the research and providing a dated and signed informed consent. If patient is unable to consent: consent from relatives will be searched, and if absent, an emergency procedure will be process
- Women of childbearing potential, provided they have a negative blood pregnancy test on the day of the inclusion visit
- Minor patients
- Patients unable to consent: under legal protection measures, patients deprived of liberty
- Kidney transplant recipients treated with Belatacept due to the persistent effect of Belatacept, it is not possible to modulate this treatment in a short term period
- Patients with severe chronic graft dysfunction (glomerular filtration rate < 20 ml/min/1.73m² according to the CKD-EPI formula in the month prior to admission
- Transplant renal recipients who have already resumed RRT (hemodialysis or peritoneal dialysis),
- Multi-organ transplant recipients
- Pregnant women
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.