Actively Recruiting
Reduction in Immunosuppressive Regimen in Kidney Transplant Patients Admitted to ICU for Septic Shock and/or Acute Respiratory Failure: A Multicenter, Open-label, Phase IIb Randomized Controlled Trial
Led by University Hospital, Strasbourg, France · Updated on 2026-06-05
212
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Kidney transplantation is a common treatment for end-stage chronic kidney disease, with many grafts performed annually in France. Immunosuppressive therapy is necessary to prevent graft rejection but increases the risk of infections and other complications. Up to 10% of kidney transplant recipients may require intensive care unit (ICU) admission due to septic shock or acute respiratory failure, conditions associated with high mortality and potential worsening of kidney graft function. The study aims to find the best way to manage immunosuppressive treatments in these critical situations to support patient recovery without increasing rejection risk. This trial compares two approaches for immunosuppressive therapy in kidney transplant patients admitted to the ICU for septic shock or acute respiratory failure. One group will have their usual immunosuppressive drugs stopped and receive hydrocortisone hemisuccinate 200 mg per day via slow intravenous injection. The other group will continue their standard immunosuppressive medications, including calcineurin inhibitors, mTOR inhibitors, azathioprine, or mycophenolate mofetil, with hydrocortisone also given. Dosage adjustments of some drugs may be made by clinicians as needed. Participants will be monitored for changes in organ function, specifically measuring the Sequential Organ Failure Assessment (SOFA) score by Day 5. Researchers will assess treatment impacts on recovery, graft function, and safety. The study involves random assignment to treatment groups and includes consent processes. The total study period and follow-up details are not specified, but the primary outcome focuses on early organ function changes after ICU admission and treatment modification.
CONDITIONS
Brief Title
Eduction in ImmunoSuppressive Regimen Among Kidney Transplant Recipients Patients Admitted to the Intensive Care Unit for Septic Shock and/or Acute Respiratory Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years and older
- Kidney transplant recipients with transplantation more than 3 months before ICU admission
- Admitted to ICU for septic shock (sepsis requiring vasopressor support) and/or acute respiratory failure of infectious origin (invasive or non-invasive ventilation, FiO2 ≥ 50%)
- Treated with at least two immunosuppressive drugs including steroids, calcineurin inhibitors, mTOR inhibitors, azathioprine, or mycophenolate mofetil
- Affiliated with a social health insurance scheme
- Able to understand study objectives and provide informed consent; if unable, consent from relatives or emergency procedure applies
- Women of childbearing potential with a negative blood pregnancy test on inclusion day
You will not qualify if you...
- Minor patients
- Patients unable to consent due to legal protection or deprivation of liberty
- Kidney transplant recipients treated with Belatacept
- Patients with severe chronic graft dysfunction (glomerular filtration rate < 20 ml/min/1.73m² in the month before admission)
- Transplant recipients who have resumed renal replacement therapy
- Multi-organ transplant recipients
- Pregnant women
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of ICU stay during septic shock and/or acute respiratory failure
Participants receive either a reduction of their usual immunosuppressive treatment combined with hydrocortisone hemisuccinate injections, or continue their usual immunosuppressive regimen with hydrocortisone hemisuccinate. Treatment involves hydrocortisone administered as a slow IV injection of 50 mg every 6 hours.
Multiple daily treatments with hydrocortisone injections during ICU stay
Duration - Up to 5 days post-treatment
Participants are monitored for changes in their organ function and clinical status after treatment.
Assessments on Day 5 after treatment initiation
Trial Site Locations
Total: 1 location
1
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Actively Recruiting
Research Team
S
Sarah Hustache
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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