NCT06881927: REDIS

Eduction in ImmunoSuppressive Regimen Among Kidney Transplant Recipients Patients Admitted to the Intensive Care Unit for Septic Shock and/or Acute Respiratory Failure

Not yet recruiting Phase 4 Last updated 18 November 2025

What this trial tests

Phase 4 trial testing Hydrocortisone Hemisuccinate: 200 mg per day. in Sepsis and Septic Shock in 212 participants. Not yet recruiting.

Timeline

1 February 2026

Primary endpoint
1 June 2029

1 June 2029

Quick facts

Lead sponsor	University Hospital, Strasbourg, France
Phase	Phase 4
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	212
Start date	1 February 2026
Primary completion	1 June 2029
Estimated completion	1 June 2029

Drugs / interventions tested

• Hydrocortisone Hemisuccinate: 200 mg per day. — full drug profile →
• reduction of the level of immunosuppression

Conditions studied

• Sepsis and Septic Shock — all drugs for Sepsis and Septic Shock →
• Acute Respiratory Failure — all drugs for Acute Respiratory Failure →
• Kidney Transplant Recipients — all drugs for Kidney Transplant Recipients →
• Immunosuppressive Agents — all drugs for Immunosuppressive Agents →

Sponsor

University Hospital, Strasbourg, France

Who can join

18 and older, any sex, with Sepsis and Septic Shock or Acute Respiratory Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.