Clinical trial • Phase III • Infectious Disease
RASBURICASE for Sepsis
Phase III trial of RASBURICASE for Sepsis.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Sepsis
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 01-08-2025
- First CTIS Authorization Date
- 24-11-2025
Trial design
Randomised, control arm: 50 ml of a sodium chloride (0.9%) single intravenous infusion associated with standard of care (placebo control). experimental arm: fasturtec (rasburicase 1.5 mg/ml) 7.5 mg, reconstituted and diluted in 50 ml sodium chloride (0.9%), single intravenous infusion over 30 minutes, associated with standard of care. Phase III trial across 8 sites in France.
- Randomised
- Yes
- Comparator
- Control arm: 50 ml of a sodium chloride (0.9%) single intravenous infusion associated with standard of care (placebo control). Experimental arm: Fasturtec (Rasburicase 1.5 mg/ml) 7.5 mg, reconstituted and diluted in 50 ml sodium chloride (0.9%), single intravenous infusion over 30 minutes, associated with standard of care.
- Target Sample Size
- 240
- Trial Duration For Participant
- 90
Eligibility
Recruits 240 Vulnerable population selected. Informed consent form required ("Informed consent form signed" as inclusion). Subject information sheets and informed consent forms are provided for patients and for 'proche' (relative/legal representative), indicating proxy/representative consent procedures may be used. Trial restricted to adults (≥18), so no assent procedures for minors..
- Pregnancy Exclusion
- Pregnant or breastfeeding woman
- Vulnerable Population
- Vulnerable population selected. Informed consent form required ("Informed consent form signed" as inclusion). Subject information sheets and informed consent forms are provided for patients and for 'proche' (relative/legal representative), indicating proxy/representative consent procedures may be used. Trial restricted to adults (≥18), so no assent procedures for minors.
Inclusion criteria
- {"criterion_text":"- Patients ≥18 years old\n- Diagnosis of sepsis (presumed or known infection and increase in SOFA score ≥ 2), included within 48 hours of diagnosis.\n- Uricémia ≥ 200 µmol/L\n- Rapid diagnostic test strip for G6PD deficiency negative\n- Patient affiliated with a social security scheme\n- Informed consent form signed\n- Woman of childbearing age using effective contraception throughout the treatment and for 1 month after the end of the treatment.\n- Hospitalised in intensive care unit"}
Exclusion criteria
- {"criterion_text":"- Minor\n- Surgery involving the kidneys or urinary tract in the last 3 months\n- Life expectancy less than 6 months\n- Pregnant or breastfeeding woman\n- Chronic kidney failure on hemodialysis\n- AKI with need for dialysis treatment estimated within 12 hours\n- Known hypersensitivity to Rasburicase, or to any of the excipients,\n- Pre-existing condition or situation at risk of lysis syndrome\n- Known G6PD deficiency or suggestive family history\n- Other metabolic disorders known to cause hemolytic anemia\n- Chronic treatment with a urate-lowering agent\n- Enrolled in another\n- Sepsis due to urinary obstruction"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Worsening of renal function defined by at least one of the following: The onset of acute kidney injury (AKI) within 7 days of inclusion. Non-improvement or progression of the stage of AKI according to KDIGO criteria on the 7th day after inclusion","definition_or_measurement_approach":"Worsening defined as either onset of AKI within 7 days of inclusion or non-improvement/progression of AKI stage according to KDIGO criteria assessed at day 7 after inclusion."}
Secondary endpoints
- {"endpoint_text":"- Death rate at D28 and D90","definition_or_measurement_approach":"Mortality assessed at day 28 and day 90."}
- {"endpoint_text":"- The maximum SOFA score during the first 7 days","definition_or_measurement_approach":"Maximum Sequential Organ Failure Assessment (SOFA) score recorded during the first 7 days."}
- {"endpoint_text":"- The evolution of renal aggression markers (N-GAL, Pro-enkephalin, IL-18) in blood and urine at D0, D3, and D7","definition_or_measurement_approach":"Serial measurement of plasma and urinary markers (N-GAL, Pro-enkephalin, IL-18) at baseline (D0), D3 and D7."}
- {"endpoint_text":"- The evolution of the leukocyte rate, pro- and anti-inflammatory cytokines (TNFα, IL-1, 6, 8, 10) at D1, D3, and D7","definition_or_measurement_approach":"Serial measurement of leukocyte count and cytokines (TNFα, IL-1, IL-6, IL-8, IL-10) at D1, D3 and D7."}
Recruitment
- Planned Sample Size
- 240
- Recruitment Window Months
- 39
- Consent Approach
- Informed consent form signed is required from the participant. Trial includes adults only (≥18). Subject information sheets and informed consent forms exist for patient and for 'proche' (relative/legal representative), indicating procedures for proxy/representative consent; continuation ('poursuite') versions and a non-opposition document for treatment/data are available. Languages not specified in the available data.
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 240
France
- Earliest CTIS Part Ii Submission Date
- 08-08-2025
- Latest Decision Or Authorization Date
- 24-11-2025
- Processing Time Days
- 108
- Number Of Sites
- 8
- Number Of Participants
- 240
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Réanimation des grands brulés
- Principal Investigator Name
- François Depret
- Principal Investigator Email
- francois.depret@aphp.fr
- Contact Person Name
- François Depret
- Contact Person Email
- francois.depret@aphp.fr
- Site Name
- Ramsay Generale De Sante
- Department Name
- Anesthésie réanimation
- Principal Investigator Name
- Matthieu Jamme
- Principal Investigator Email
- mat.jamme@gmail.com
- Contact Person Name
- Matthieu Jamme
- Contact Person Email
- mat.jamme@gmail.com
- Site Name
- Centre Hospitalier Victor Dupouy
- Department Name
- Anesthésie réanimation
- Principal Investigator Name
- Gaetan Plantefeve
- Principal Investigator Email
- gaetan.plantefeve@ch-argenteuil.fr
- Contact Person Name
- Gaetan Plantefeve
- Contact Person Email
- gaetan.plantefeve@ch-argenteuil.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- ANESTHESIE REANIMATION CHIRURGICALE SMUR
- Principal Investigator Name
- Benjamin Chousterman
- Principal Investigator Email
- benjamin.chouterman@aphp.fr
- Contact Person Name
- Benjamin Chousterman
- Contact Person Email
- benjamin.chouterman@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Reanimation medico-chirurgicale
- Principal Investigator Name
- Adrien Picod
- Principal Investigator Email
- adrien.picod@aphp.fr
- Contact Person Name
- Adrien Picod
- Contact Person Email
- adrien.picod@aphp.fr
- Site Name
- Ramsay Generale De Sante
- Department Name
- Anesthésie Réanimation
- Principal Investigator Name
- Riad Chelha
- Principal Investigator Email
- r.chelha@free.fr
- Contact Person Name
- Riad Chelha
- Contact Person Email
- r.chelha@free.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- REANIMATION DE CHIRURGIE CARDIO-VASCULAIRE
- Principal Investigator Name
- Nicolas Mongardon
- Principal Investigator Email
- nicolas.mongardon@aphp.fr
- Contact Person Name
- Nicolas Mongardon
- Contact Person Email
- nicolas.mongardon@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Réanimation médicale
- Principal Investigator Name
- Bruno Megarbane
- Principal Investigator Email
- bruno.megarbane@aphp.fr
- Contact Person Name
- Bruno Megarbane
- Contact Person Email
- bruno.megarbane@aphp.fr
Sponsor
Primary sponsor
- Full Name
- Assistance Publique Hopitaux De Paris
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion.
- Active Substance
- RASBURICASE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Authorised (EU/1/00/170/002)
- Starting Dose
- 7.5 mg
- Dose Levels
- 7.5 mg
- Frequency
- Single intravenous infusion (30 minutes)
- Maximum Dose
- 7.5 mg
- Investigational Product Name
- Placebo de fasturtec
- Modality
- Other
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Starting Dose
- 50 ml sodium chloride (0.9%)
- Frequency
- Single intravenous infusion
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