Sepsis and Septic ShockPhase 4REDISNCT06881927
Eduction in ImmunoSuppressive Regimen Among Kidney Transplant Recipients Patients Admitted to the Intensive Care Unit for Septic Shock and/or Acute Respiratory Failure
A Phase 4 study testing Hydrocortisone Hemisuccinate: 200 mg per day. and reduction of the level of immunosuppression in people with Sepsis and Septic Shock and Acute Respiratory Failure, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Kidney transplantation is the treatment of choice for end-stage chronic kidney disease. Kidney transplantation is at the first rank of solid organ transplantation in France, with 3,376 grafts performed in 2022. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis and Septic Shock, Acute Respiratory Failure, Kidney Transplant Recipients
- What is being tested?
- Hydrocortisone Hemisuccinate: 200 mg per day. and reduction of the level of immunosuppression
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteFrance
- Study dates
- 11 Aug 2026to 1 Aug 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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),
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg
Julien DEMISELLE, 03 69 55 10 79 ext. +33, julien.demiselle@chru-strasbourg.fr
About this study
Official title: Reduction in ImmunoSuppressive Regimen Among Kidney Transplant Recipients Patients Admitted to the Intensive Care Unit for Septic Shock and/or Acute Respiratory Failure: a Multicenter, Open-label, Phase IIb Randomized Controlled Trial
Kidney transplantation is the treatment of choice for end-stage chronic kidney disease. Kidney transplantation is at the first rank of solid organ transplantation in France, with 3,376 grafts performed in 2022. Immunosuppressive therapy, required to prevent graft rejection, exposes graft recipients to complications related to decreased immunity, including opportunistic infections and neoplastic complications.
After the earlt post-transplantation period, up to 10% of kidney transplant recipients will require admission to the intensive care unit (ICU). The main reasons for admission are septic shock and acute hypoxemic respiratory failure. ICU stay has a significant impact on these patients with a mortality rate reaching 40%, that remains increased even after ICU discharge. Furthermore, an impact on graft function has been demonstrated, with deterioration of graft function in 1/3 of patients, and among those, up to one in two will require resumption of renal replacement therapy (RRT).
Read more
Although the occurrence of septic shock or acute respiratory failure related to an infection is more common and severe, the optimal management strategy for immunosuppressors is not defined in kidney transplant recipients admitted to the ICU in those settings.
Maintain a high level of immunosuppressive therapies may hinder the recovery from the acute critical condition. Furthermore, these treatments have a narrow therapeutic index; for instance, the management of calcineurin inhibitors is challenging in the ICU due to pharmacodynamic changes associated with the acute situation (distribution volume, organ failure) and the numerous potential drug interactions that carry inherent risks of overdose.
the investigators hypothesize that a reduction in the level of immunosuppressive treatments could promote recovery in kidney transplant recipients admitted to the ICU for septic shock and/or acute hypoxemic respiratory failure, without adversely affecting the risk of rejection or long-term renal prognosis.
- Conditions
- Sepsis and Septic Shock, Acute Respiratory Failure, Kidney Transplant Recipients, Immunosuppressive Agents
- Being tested
- Hydrocortisone Hemisuccinate: 200 mg per day., reduction of the level of immunosuppression
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone Hemisuccinate: 200 mg per day.Drug
The hydrocortisone hemisuccinate is a powder and solvent for injectable solution at 100 mg. The powder must be dissolved in the solvent to ensure final isotonicity. The solution must be used within 24 hours. The injection is performed as a slow direct IV injection, either via an electric syringe pump or as a bolus of 50 mg every 6 hours
reduction of the level of immunosuppressionOther
In this arm, the usual immunosuppressive treatment of the patients will be discontinued.
Patients will receive hydrocortisone hemisuccinate 200 mg per day (slow direct intraveinous injection of 50 mg four times a day, or through an electric syringe pump).
| Study group | Role | What they receive |
|---|---|---|
| reduction of the level of immunosuppression | Experimental | In this arm, the usual immunosuppressive treatment of the patients will be discontinued.
Patients will receive hydrocortisone hemisuccinate 200 mg per day (slow direct intraveinous injection of 50 mg four times a day, or through an electric syringe pump). Receives: Other: reduction of the level of immunosuppression |
| usual immunosuppression maintenance | Active comparator | In this group: patients will receive hydrocortisone hemisuccinate 200 mg per day (slow direct intraveinous injection of 50 mg four times a day, or through an electric syringe pump).
The usual treatment with immunosuppressive agents will be continue: calcineurin inhibitors and/or mTOR inhibitors and/or Azathioprine, and/or Mycophénolate Mofétil (MMF)/Mycophenolice Acide (MPA).
For MMF/MPA, at the discretion of the treating clinicians, dosage may be reduced or drug discontinued. Receives: Drug: Hydrocortisone Hemisuccinate: 200 mg per day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the rate of patients showing a change in the SOFA (Sequential Organ Failure Assessment) score of at least 4 points
SOFA score is a usual score used to assess gravity and its evolution among critically ill patients (ICM 1996)
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start11 Aug 2026
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis and Septic ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881927
- Sponsor's protocol ID
- 9416
- Acronym
- REDIS
- Status last verified
- Aug 2026
- First submitted
- 11 Mar 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction in ImmunoSuppressive Regimen Among Kidney Transplant Recipients Patients Admitted to the Intensive Care Unit for Septic Shock and/or Acute Respiratory Failure: a Multicenter, Open-label, Phase IIb Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06881927
- Acronym / sponsor ID
- REDIS / 9416
- Conditions
- Sepsis and Septic Shock, Acute Respiratory Failure, Kidney Transplant Recipients, Immunosuppressive Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Kidney transplantation is the treatment of choice for end-stage chronic kidney disease. Kidney transplantation is at the first rank of solid organ transplantation in France, with 3,376 grafts performed in 2022. Immunosuppressive therapy, required to prevent graft rejection, exposes graft recipients to complications related to decreased immunity, including opportunistic infections and neoplastic complications.
After the earlt post-transplantation period, up to 10% of kidney transplant recipients will require admission to the intensive care unit (ICU). The main reasons for admission are septic shock and acute hypoxemic respiratory failure. ICU stay has a significant impact on these patients with a mortality rate reaching 40%, that remains increased even after ICU discharge. Furthermore, an impact on graft function has been demonstrated, with deterioration of graft function in 1/3 of patients, and among those, up to one in two will require resumption of renal replacement therapy (RRT).
Although the occurrence of septic shock or acute respiratory failure related to an infection is more common and severe, the optimal management strategy for immunosuppressors is not defined in kidney transplant recipients admitted to the ICU in those settings.
Maintain a high level of immunosuppressive therapies may hinder the recovery from the acute critical condition. Furthermore, these treatments have a narrow therapeutic index; for instance, the management of calcineurin inhibitors is challenging in the ICU due to pharmacodynamic changes associated with the acute situation (distribution volume, organ failure) and the numerous potential drug interactions that carry inherent risks of overdose.
the investigators hypothesize that a reduction in the level of immunosuppressive treatments could promote recovery in kidney transplant recipients admitted to the ICU for septic shock and/or acute hypoxemic respiratory failure, without adversely affecting the risk of rejection or long-term renal prognosis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reduction of the level of immunosuppression | Experimental | Other: reduction of the level of immunosuppressionIn this arm, the usual immunosuppressive treatment of the patients will be discontinued. Patients will receive hydrocortisone hemisuccinate 200 mg per day (slow direct intraveinous injection of 50 mg four times a day, or through an electric syringe pump). |
| usual immunosuppression maintenance | Active comparator | Drug: Hydrocortisone Hemisuccinate: 200 mg per day.In this group: patients will receive hydrocortisone hemisuccinate 200 mg per day (slow direct intraveinous injection of 50 mg four times a day, or through an electric syringe pump). The usual treatment with immunosuppressive agents will be continue: calcineurin inhibitors and/or mTOR inhibitors and/or Azathioprine, and/or Mycophénolate Mofétil (MMF)/Mycophenolice Acide (MPA). For MMF/MPA, at the discretion of the treating clinicians, dosage may be reduced or drug discontinued. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- - 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:
- 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,
Key exclusion criteria (7 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortisone Hemisuccinate: 200 mg per day.The hydrocortisone hemisuccinate is a powder and solvent for injectable solution at 100 mg. The powder must be dissolved in the solvent to ensure final isotonicity. The solution must be used within 24 hours. The injection is performed as a slow direct IV injection, either via an electric syringe pump or as a bolus of 50 mg every 6 hours | Drug | usual immunosuppression maintenance |
| reduction of the level of immunosuppressionIn this arm, the usual immunosuppressive treatment of the patients will be discontinued. Patients will receive hydrocortisone hemisuccinate 200 mg per day (slow direct intraveinous injection of 50 mg four times a day, or through an electric syringe pump). | Other | reduction of the level of immunosuppression |
Primary outcome
The primary endpoint is the rate of patients showing a change in the SOFA (Sequential Organ Failure Assessment) score of at least 4 points
Time frame: Day 5
SOFA score is a usual score used to assess gravity and its evolution among critically ill patients (ICM 1996)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Sepsis and Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone Hemisuccinate: 200 mg per day. and reduction of the level of immunosuppression in people with Sepsis and Septic Shock and Acute Respiratory Failure, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Hustache (00338811, dpidric@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the rate of patients showing a change in the SOFA (Sequential Organ Failure Assessment) score of at least 4 points (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.