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

Start 10 Apr 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 10 sites · Protocol 9416

Overview

Sponsor-declared trial summary

Phase Phase II and Phase III (Integrated)

Status Ongoing, recruiting

Participants planned 212

Countries 1

Sites 10

kidney transplant

To evaluate the effectiveness of a strategy of reduction in the level of immunosuppressive treatments to improve organ(s) failure(s) at day 5.

Key facts

Sponsor: Les Hopitaux Universitaires De Strasbourg
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Not possible to specify
Trial duration: 10 Apr 2026 → ongoing
Decision date (initial): 2025-08-07
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate the effectiveness of a strategy of reduction in the level of immunosuppressive treatments to improve organ(s) failure(s) at day 5.

Secondary objectives 1

To evaluate the effects effectiveness of a strategy of reduction in the level of immunosuppressive treatments on : 1) In-ICU mortality and mortality at month 6 2) Daily evolution of organ failures (from day 1 to 7) 3) Renal function evolution (end of ICU stay and at month 6) 4) RRT requirement (during ICU stay and at month 6) 5) The occurrence of acute kidney graft rejection (cellular and/or humoral) until month 6 6) The level of anti-Human Leucocyte Antigen antibodies at month 6 7) The number of severe infection between ICU discharge and month 6

Conditions and MedDRA coding

kidney transplant

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

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

Exclusion criteria 7

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

The primary endpoint is the rate of patients showing a reduction in the SOFA (Sequential Organ Failure Assessment) score of at least 4 points at day 5

Secondary endpoints 7

Vital status at discharge from the ICU and at month 6
Daily evolution of the SOFA score (from day 1 to day 7)
Serum creatinine level and glomerular filtration rate (GFR, in ml/min) at discharge from the ICU, assessed by the UV/P method (urine creatinine * diuresis / plasma creatinine). Given the usual collection of 24-hour urine in intensive care, this cost-effective approach is easily achievable and is the most relevant in intensive care
Dialysis status (during ICU stay and at month 6): use of dialysis, modality of dialysis, weaning from RRT at discharge between ICU discharge and month 6
Histological evidence (graft biopsy) and characterization of rejection according to the Banff classification, for any sample taken between discharge from the ICU and month 6 (biopsy for cause only).
Evaluation of anti-HLA immunization will be performed on a blood sample at month 6, with screening for Donor-Specific Antibodies
Collection of significant infection episodes from ICU discharge to month 6. An infection will be considered significant if it requires hospitalization. Additionally, during the 6-month consultation, blood replication for CMV, EBV, and BK virus and urinary replication of BK virus (assessed with Polymerase Chain Reaction tests) will be collected as part of routine care

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

HYDROCORTISONE UPJOHN 100 mg, préparation injectable

PRD345050 · Product

Active substance: Hydrocortisone
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS USE
Max daily dose: 200 mg milligram(s)
Max total dose: 200 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: H02AB09 — HYDROCORTISONE
Marketing authorisation: 34009 337 312 1 2
MA holder: SERB
MA country: France
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Comparator 9

CORTANCYL 1 mg, comprimé

PRD9995013 · Product

Active substance: Prednisone
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 3.6 g gram(s)
Max treatment duration: 6 Month(s)
Authorisation status: Authorised
ATC code: H02AB07 — PREDNISONE
Marketing authorisation: 34009 325 085 5 6
MA holder: CHEPLAPHARM ARZNEIMITTEL GMBH
MA country: France
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Certican 0,5 mg comprimidos

PRD10404823 · Product

Active substance: Everolimus
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 2 mg milligram(s)
Max total dose: 3.6 g gram(s)
Max treatment duration: 6 Month(s)
Authorisation status: Authorised
ATC code: L04AH02 — -
Marketing authorisation: SE/H/0356/002
MA holder: NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A.
MA country: Portugal
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rapamune 0.5 mg coated tablets

PRD3342089 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Max daily dose: 40 mg milligram(s)
Max total dose: 3.6 g gram(s)
Max treatment duration: 3 Month(s)
Authorisation status: Authorised
ATC code: L04AH01 — -
Marketing authorisation: EU/1/01/171/013
MA holder: PFIZER EUROPE MA EEIG
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Advagraf 0.5 mg prolonged-release hard capsules

PRD324600 · Product

Active substance: Tacrolimus
Pharmaceutical form: PROLONGED-RELEASE CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 14 mg milligram(s)
Max total dose: 84 g gram(s)
Max treatment duration: 6 Month(s)
Authorisation status: Authorised
ATC code: L04AD02 — -
Marketing authorisation: EU/1/07/387/002
MA holder: ASTELLAS PHARMA EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

CellCept 250 mg capsules

PRD2153965 · Product

Active substance: Mycophenolate Mofetil
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 2 g gram(s)
Max total dose: 360 g gram(s)
Max treatment duration: 6 Month(s)
Authorisation status: Authorised
ATC code: L04AA06 — MYCOPHENOLIC ACID
Marketing authorisation: EU/1/96/005/001
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

SOLUMEDROL 500 mg, poudre pour solution injectable

PRD457223 · Product

Active substance: Methylprednisolone Hydrogen Succinate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 250 mg milligram(s)
Max total dose: 750 mg milligram(s)
Max treatment duration: 3 Day(s)
Authorisation status: Authorised
ATC code: H02AB04 — METHYLPREDNISOLONE
Marketing authorisation: 34009 386 777 4 4
MA holder: PFIZER HOLDING FRANCE
MA country: France
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Myfortic 180 mg comprimés gastro-résistants

PRD1928350 · Product

Active substance: Mycophenolic Acid
Pharmaceutical form: GASTRO-RESISTANT TABLET
Route of administration: ORAL
Max daily dose: 1440 mg milligram(s)
Max total dose: 260 g gram(s)
Max treatment duration: 6 Month(s)
Authorisation status: Authorised
ATC code: L04AA06 — MYCOPHENOLIC ACID
Marketing authorisation: 2004030120
MA holder: NOVARTIS PHARMA N.V.
MA country: Luxembourg
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

IMUREL 25 mg, comprimé pelliculé

PRD980769 · Product

Active substance: Azathioprine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 150 mg milligram(s)
Max total dose: 27 g gram(s)
Max treatment duration: 6 Month(s)
Authorisation status: Authorised
ATC code: L04AX01 — AZATHIOPRINE
Marketing authorisation: 34009 364 145 5 6
MA holder: ASPEN PHARMA TRADING LIMITED
MA country: France
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Neoral 100 mg Soft Capsules

PRD11347538 · Product

Active substance: Ciclosporin
Pharmaceutical form: CAPSULE, SOFT
Route of administration: ORAL
Max daily dose: 10 mg milligram(s)
Max total dose: 1.8 g gram(s)
Max treatment duration: 6 Month(s)
Authorisation status: Authorised
ATC code: L04AD01 — -
Marketing authorisation: PA 0896/024/003
MA holder: NOVARTIS IRELAND LIMITED
MA country: Ireland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Les Hopitaux Universitaires De Strasbourg

Sponsor organisation: Les Hopitaux Universitaires De Strasbourg
Address: 1 Place De L Hopital, Cs 80426 Cs 80426
City: Strasbourg Cedex
Postcode: 67091
Country: France

Scientific contact point

Organisation: Les Hopitaux Universitaires De Strasbourg
Contact name: Julien DEMISELLE

Public contact point

Organisation: Les Hopitaux Universitaires De Strasbourg
Contact name: Julien DEMISELLE

Locations

1 EU/EEA country · 10 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ongoing, recruiting	212	10
Rest of world	—	0	—

Investigational sites

France

10 sites · Ongoing, recruiting

Hospices Civils De Lyon

intensive care, 5 Place D Arsonval, 69437, Lyon Cedex 03

Centre Hospitalier Universitaire De Dijon

intensive care, 14 Rue Paul Gaffarel, 21000, Dijon

Les Hopitaux Universitaires De Strasbourg

intensive care, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex

Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace

intensive care, 20 Avenue Du Docteur Rene Laennec, 68100, Mulhouse

Centre Hospitalier De Colmar

intensive care, 39 Avenue De La Liberte, Bp 60535, Colmar Cedex

CHRU De Nancy

intensive care, Rue Du Morvan, 54500, Vandoeuvre Les Nancy

Centre Hospital Region Metz Thionville

intensive care, 1 Allee Du Chateau, Cs 45001 Ars Laquenexy, Metz Cedex 03

Centre Hospitalier Regional Universitaire De Tours

intensive care, 2 Boulevard Tonnelle, 37000, Tours

Centre Hospitalier Regional D'Angers

intensive care, 4 Rue Larrey, 49100, Angers

CHU Besancon

intensive care, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
France	2026-04-10		2026-05-11

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol_public_2024-518493-14-00 -	2.1
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1
Subject information and informed consent form (for publication)	L1_ SIS and ICF Poursuite Participation patient	1.2
Subject information and informed consent form (for publication)	L1_ SIS and ICF accord famille-personne de confiance	1.2
Subject information and informed consent form (for publication)	L1_ SIS and ICF accord famille-personne de confiance	1.2
Subject information and informed consent form (for publication)	L1_ SIS and ICF majeur	1.2
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_advagraf	1
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_cellcept	1
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_CERTICAN	1
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_cortancyl	1
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_HYDROCORTISONE	1
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_IMUREL	1
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_MYFORTIC	1
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_Neoral	1
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_rapamune	1
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_SOLUMEDROL	1
Synopsis of the protocol (for publication)	D1_Protocol_synopsis_FR_2024-518493-14-00 - Copie	1.3

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-04-14	France	Acceptable with conditions 2025-08-04	2025-08-07
2	SUBSTANTIAL MODIFICATION	SM-1	2025-10-24	France	Acceptable 2025-11-18	2025-11-19

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

Overview

Key facts

Trial design

Main objective

Secondary objectives 1

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 7

Exclusion criteria 7

Endpoints

Primary endpoints 1

Secondary endpoints 7

Investigational products

Test 1

Comparator 9

Sponsors and contacts

Les Hopitaux Universitaires De Strasbourg

Scientific contact point

Public contact point

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 17 files

Application history

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