Could cutting immune drugs save kidney transplants during severe infections?

NCT ID NCT06881927

Disease control Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study tests whether reducing immunosuppressive drugs (along with giving a steroid) helps kidney transplant patients recover from septic shock or severe breathing failure in the ICU. About 212 adults whose transplant was at least 3 months ago will be randomly assigned to either lower their usual immune drugs or continue them. The goal is to see if this approach improves organ function without raising the risk of rejection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Hydrocortisone hemisuccinate (a steroid) and reduction of usual immunosuppressive drugs
What this could lead to: If it works, this could lead to a safer way to manage immunosuppression during critical illness, improving recovery and reducing organ damage in kidney transplant patients.
What could go wrong: This is a Phase 4 trial with 212 participants, so results are not yet proven. Reducing immunosuppression may increase the risk of graft rejection, and the steroid itself has side effects.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 212 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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: * Septic shock (sepsis requiring vasopressor support, with or without hyperlactatemia), * 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. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

acute respiratory failure infectious disease with sepsis Sepsis toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute respiratory failure Immunosuppressive agents Kidney transplant recipients Sepsis and septic shock

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could cutting immune drugs save kidney transplants during severe infections?

What the study statuses mean