Patients hospitalis… · Phase III (2023-508071-36-00)

Status Authorised, recruitment pending · 1 EU/EEA countries · 8 sites · Protocol APHP191099

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Authorised, recruitment pending

Participants planned 240

Countries 1

Sites 8

Patients hospitalised in intensive care, diagnosed with sepsis less than 48 hours ago, uric acid level ≥200µmol/L, adults, negative G6PD deficiency

Determine the effect of Rasburicase on the occurrence and evolution of acute renal failure (ARF) in septic patients with uricemia ≥200 µmol/L.

Key facts

Sponsor: Assistance Publique Hopitaux De Paris
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Decision date (initial): 2025-11-24
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: French Ministry of Health

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Determine the effect of Rasburicase on the occurrence and evolution of acute renal failure (ARF) in septic patients with uricemia ≥200 µmol/L.

Secondary objectives 4

To determine if treatment with Rasburicase vs placebo is associated with A decrease in mortality.
To determine if treatment with Rasburicase vs placebo is associated with an improvement of other organs dysfunction
To determine if treatment with Rasburicase vs placebo is associated with a decrease in plasma and urinary markers of kidney injury
To determine if treatment with Rasburicase vs placebo is associated with a decrease of inflammatory syndrome

Conditions and MedDRA coding

Patients hospitalised in intensive care, diagnosed with sepsis less than 48 hours ago, uric acid level ≥200µmol/L, adults, negative G6PD deficiency

Study design 1 period

#	Title	Allocation	Blinding	Roles blinded	Arms
1	treatment period depending on the randomisation, patient will receive a single perfusion of either 7.5mg Fasturtec (Rasburicase1,5 mg/ml), solution for injectionsolution injectable reconstituée, à diluer dans 50 ml d’une solution injectable de chlorure de sodium (0.9%), perfusion unique en intraveineuse de 30 minutes 7.5mg (Rasburicase1.5 mg/ml), reconstituted injectable solution, to be diluted in 50 ml of a sodium chloride (0.9%) injectable solution, single intravenous infusion of 30 minutes	Randomised Controlled	Double	[{"id":153107,"code":5,"name":"Carer"},{"id":153103,"code":4,"name":"Analyst"},{"id":153106,"code":3,"name":"Monitor"},{"id":153104,"code":1,"name":"Subject"},{"id":153105,"code":2,"name":"Investigator"}]	Groupe experimental: 7.5mg de Fastrutec (Rasburicase 1,5mg/ml), solution injectable reconstituée, diluée dans 50 ml d’une solution injectable de chlorure de sodium (0.9%) en perfusion unique, associé à la prise en charge standard Groupe control: 50 ml d’une solution injectable de chlorure de sodium (0.9%) en perfusion unique associé à la prise en charge standard

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

Patients ≥18 years old
Diagnosis of sepsis (presumed or known infection and increase in SOFA score ≥ 2), included within 48 hours of diagnosis.
Uricémia ≥ 200 µmol/L
Rapid diagnostic test strip for G6PD deficiency negative
Patient affiliated with a social security scheme
Informed consent form signed
Woman of childbearing age using effective contraception throughout the treatment and for 1 month after the end of the treatment.
Hospitalised in intensive care unit

Exclusion criteria 13

Minor
Surgery involving the kidneys or urinary tract in the last 3 months
Life expectancy less than 6 months
Pregnant or breastfeeding woman
Chronic kidney failure on hemodialysis
AKI with need for dialysis treatment estimated within 12 hours
Known hypersensitivity to Rasburicase, or to any of the excipients,
Pre-existing condition or situation at risk of lysis syndrome
Known G6PD deficiency or suggestive family history
Other metabolic disorders known to cause hemolytic anemia
Chronic treatment with a urate-lowering agent
Enrolled in another
Sepsis due to urinary obstruction

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 4

Death rate at D28 and D90
The maximum SOFA score during the first 7 days
The evolution of renal aggression markers (N-GAL, Pro-enkephalin, IL-18) in blood and urine at D0, D3, and D7
The evolution of the leukocyte rate, pro- and anti-inflammatory cytokines (TNFα, IL-1, 6, 8, 10) at D1, D3, and D7

Investigational products

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

Test 1

Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion.

PRD502037 · Product

Active substance: Rasburicase
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENUS USE
Max daily dose: 7.5 mg milligram(s)
Max total dose: 7.5 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: V03AF07 — RASBURICASE
Marketing authorisation: EU/1/00/170/002
MA holder: SANOFI WINTHROP INDUSTRIE
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Placebo 1

Placebo de fasturtec

N/A · Product

Other product name: N/A
Pharmaceutical form: N/A
ATC code: N/A — N/A
Marketing authorisation: N/A
MA holder: N/A
MA country: Iceland
Paediatric formulation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation: Assistance Publique Hopitaux De Paris
Address: 1 Avenue Claude Vellefaux
City: Paris
Postcode: 75010
Country: France

Scientific contact point

Organisation: Assistance Publique Hopitaux De Paris
Contact name: Benjamin Chousterman

Public contact point

Organisation: Assistance Publique Hopitaux De Paris
Contact name: Benjamin Chousterman

Locations

1 EU/EEA country · 8 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Authorised, recruitment pending	240	8
Rest of world	—	0	—