A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS

PHASE2CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

October 6, 2022

Primary Completion Date

May 15, 2023

Study Completion Date

July 14, 2023

Conditions
Diarrhea-Associated Hemolytic Uremic SyndromePediatric Kidney DiseaseHemolytic-Uremic Syndrome
Interventions
DRUG

INM004

Two 4 mg/kg doses of INM004, 24 h (±2 h) apart, will be assessed. Each dose will be administered as an intravenous infusion during 50 min.

OTHER

SoC

Standard of care

Trial Locations (16)

1199

Hospital Italiano de Buenos Aires, Ciudad Autonoma de Buenos Aire

1270

Hospital General de Niños Pedro de Elizalde, Buenos Aires

8000

Hospital Interzonal Dr. José Penna, Bahía Blanca

Unknown

Hospital De Niños Sor María Ludovica, La Plata

Hospital Interzonal Especializado Materno Infantil Don Victorio Tetamanti, Mar del Plata

Hospital El Cruce - Néstor Kirchner, San Juan Bautista

Hospital Dr. Lucio Molas, Santa Rosa

Sanatorio de Niños, Rosario

Clínica Zabala Swiss Medical, Buenos Aires

Hospital de Pediatría Garrahan, Buenos Aires

Hospital de Niños Dr. Ricardo Gutierrez, Ciudad Autonoma de Buenos Aire

Sanatorio Güemes, Ciudad Autonoma de Buenos Aire

Hospital de Niños de la Santísima Trinidad, Córdoba

Sanatorio Allende, Córdoba

Hospital Pediátrico Dr. Humberto Notti, Mendoza

Hospital Provincial Neuquén Dr. Eduardo Castro Rendón, Neuquén

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

KLIXAR

UNKNOWN

collaborator

Linical Co., Ltd.

INDUSTRY

collaborator

PHV LATAM

UNKNOWN

lead

Inmunova S.A.

OTHER

NCT05569746 - A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS | Biotech Hunter | Biotech Hunter