Actively Recruiting
A Phase III Study to Evaluate the Efficacy of INM004 (Shiga Antitoxin) in Pediatric Patients With Shiga Toxin-producing Escherichia Coli-associated Hemolytic Uremic Syndrome
Led by Inmunova S.A. · Updated on 2026-01-15
220
Participants Needed
52
Research Sites
17 weeks
Total Duration
On this page
Sponsors
I
Inmunova S.A.
Lead Sponsor
E
Exeltis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, and pharmacokinetics of INM004 in children with Hemolytic Uremic Syndrome caused by Shiga toxin-producing Escherichia coli (STEC-HUS). This study aims to assess how well INM004, when added to standard care, improves kidney function and reduces complications, mortality, and hospital stay in affected pediatric patients. Participants will be randomly assigned to receive either two doses of INM004, an Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin fragment, or two doses of a placebo solution. Each dose is given intravenously 24 hours apart, with infusion times adjusted based on body mass index. The study includes a 28-day acute phase and further assessments up to 90 days to monitor recovery and other health outcomes. During the study, children will undergo evaluations of kidney function, blood tests for markers of disease activity, and safety assessments. Researchers will measure the time to kidney function recovery as the primary outcome, along with mortality rates, dialysis needs, and hospital stay length. The trial lasts for at least 90 days, including close monitoring of health status and medication effects throughout this period.
CONDITIONS
Brief Title
Efficacy of INM004 in Children With STEC-HUS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 9 months or older and under 18 years at randomization
- Confirmation of STEC infection for subjects under 1 year or 15 years and older by stool tests or serum antibodies
- Hospitalization at the participating institution
- Onset of diarrhea within 10 days before STEC-HUS diagnosis
- Diagnosis of STEC-HUS with signs of kidney damage, hemolysis, and platelet consumption confirmed by specific laboratory tests
- Signed informed consent by subject or legal guardian and assent when appropriate
- Negative pregnancy test for subjects who have had menarche
You will not qualify if you...
- Started dialysis within 48 hours before admission
- More than 24 hours from STEC-HUS diagnosis to randomization
- History of chronic or recurrent hemolytic anemia, thrombocytopenia, or chronic kidney disease
- Personal or family history of atypical HUS
- HUS suspected to be caused by infections other than gastrointestinal or other causes like drugs or autoimmune disorders
- Any acute or chronic medical condition interfering with study evaluation
- History of anaphylaxis or allergic reaction to equine serum
- Pregnant or breastfeeding
- Unable to be hospitalized at the participating institution
- Participation in another clinical trial within the last 3 months
- Severe malnutrition according to WHO guidelines
- Medical conditions affecting kidney function or increasing neurological risk such as congenital anomalies, epilepsy, trisomy 21, or prematurity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 days
Participants receive two doses of INM004 or placebo by intravenous infusion 24 hours apart, alongside standard care, to treat STEC-HUS and improve kidney function.
2 infusion visits (in-person, 1 day apart)
Duration - Up to 90 days
Participants are monitored for recovery of kidney function and safety outcomes for up to 90 days after treatment.
Multiple follow-up visits during 90 days
Trial Site Locations
Total: 52 locations
1
Hospital Interzonal Dr. José Penna
Bahía Blanca, Buenos Aires, Argentina, 8000
Not Yet Recruiting
2
Hospital Penna
Bahía Blanca, Buenos Aires, Argentina
Not Yet Recruiting
3
Hospital de niños Sor María Ludovica
La Plata, Buenos Aires, Argentina, 1900
Actively Recruiting
4
Clinica del niño y la madre
Mar del Plata, Buenos Aires, Argentina, 7600
Actively Recruiting
5
Hospital Interzonal Especializado Materno Infantil Don Victorio Tetamanti
Mar del Plata, Buenos Aires, Argentina
Actively Recruiting
6
Sanatorio de la Trinidad Ramos Mejia
Ramos Mejía, Buenos Aires, Argentina
Not Yet Recruiting
7
Hospital El Cruce
San Juan Bautista, Buenos Aires, Argentina
Not Yet Recruiting
8
Sanatorio Güemes
Buenos Aires, Buenos Aires F.D., Argentina, 1188
Active, Not Recruiting
9
Hospital de Pediatría S.A.M.I.C. "Prof. Dr. Juan P. Garrahan"
Buenos Aires, Buenos Aires F.D., Argentina, 1245
Actively Recruiting
10
Hospital General de Niños Pedro de Elizalde
Buenos Aires, Buenos Aires F.D., Argentina, 1270
Active, Not Recruiting
11
Sanatorio Anchorena
CABA, Buenos Aires F.D., Argentina, 1425
Active, Not Recruiting
12
Hospital Privado Centro Médico de Córdoba
Córdoba, Córdoba Province, Argentina, 5016
Actively Recruiting
13
Hospital de Niños de la Santísima Trinidad
Córdoba, Córdoba Province, Argentina
Actively Recruiting
14
Hospital "San Antonio de Padua" Río Cuarto
Río Cuarto, Córdoba Province, Argentina, 5806
Actively Recruiting
15
Hospital Pediátrico Dr. Humberto Notti
Mendoza, Mendoza Province, Argentina
Actively Recruiting
16
Hospital Teodoro J. Schestakow
San Rafael, Mendoza Province, Argentina, 5600
Actively Recruiting
17
Clínica Pediátrica San Lucas
Neuquén, Neuquén Province, Argentina, 8300
Suspended
18
Hospital Público Materno Infantil
Salta, Salta Province, Argentina, 4400
Actively Recruiting
19
Hospital Pediátrico San Luis
San Luis, San Luis Province, Argentina, 5700
Actively Recruiting
20
Hospital de Niños Zona Norte "Dr. Roberto M. Carra"
Rosario, Santa Fe Province, Argentina, 2013
Actively Recruiting
21
Sanatorio de Niños
Rosario, Santa Fe Province, Argentina
Actively Recruiting
22
Hospital De Clínicas Pte. Nicolás Avellaneda
San Miguel de Tucumán, Tucumán Province, Argentina, 4001
Active, Not Recruiting
23
Clínica Zabala
Ciudad Autonoma de Buenos Aire, Argentina
Active, Not Recruiting
24
Hospital de Niños Dr. Ricardo Gutierrez
Ciudad Autonoma de Buenos Aire, Argentina
Actively Recruiting
25
Sanatorio Allende
Córdoba, Argentina
Withdrawn
26
Cliniques universitaires Saint-Luc
Brussels, Belgium
Active, Not Recruiting
27
CHU De Bordeaux
Bordeaux, France
Active, Not Recruiting
28
Hospices Civils De Lyon - Hopital Femme Mere Enfant
Lyon, France
Actively Recruiting
29
Centre Hospitalier Universitaire De Montpellier
Montpellier, France
Active, Not Recruiting
30
CHU Nantes
Nantes, France
Not Yet Recruiting
31
Hospital Necker Enfants Malades
Paris, France
Active, Not Recruiting
32
Robert Debre University Hospital
Paris, France
Actively Recruiting
33
Trousseau Hospital
Paris, France
Active, Not Recruiting
34
CHU Rouen
Rouen, France
Not Yet Recruiting
35
Charité - Universitätsmedizin Berlin
Berlin, Germany
Not Yet Recruiting
36
University Hospital Cologne AöR
Cologne, Germany
Not Yet Recruiting
37
Universitaetsklinikum Heidelberg AöR
Heidelberg, Germany
Actively Recruiting
38
Children's Health Ireland
Dublin, Ireland
Active, Not Recruiting
39
University Hospital Consorziale Policlinico
Bari, Italy
Actively Recruiting
40
IRCCS Sant'Orsola
Bologna, Italy
Not Yet Recruiting
41
Istituto Gianina Gaslini
Genova, Italy
Actively Recruiting
42
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
Actively Recruiting
43
Azienda Ospedale Università
Padova, Italy
Not Yet Recruiting
44
Spitalul Clinic de Urgenta pentru Copii Marie Sklodowska Curie
Bucharest, Romania
Not Yet Recruiting
45
Spitalul Clinic De Urgenta Pentru Copii Cluj-Napoca
Cluj-Napoca, Romania
Actively Recruiting
46
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu
Timișoara, Romania
Not Yet Recruiting
47
Hospital Universitario De Cruces
Barakaldo, Spain
Actively Recruiting
48
Hospital Infantil Universitario Niño Jesus
Madrid, Spain
Actively Recruiting
49
Hospital Universitario 12 De Octubre
Madrid, Spain
Actively Recruiting
50
Bristol Royal Hospital for Children
Bristol, United Kingdom
Not Yet Recruiting
51
Royal Hospital for Sick Children
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
52
Great Ormon Street Hospital for Children
London, United Kingdom
Not Yet Recruiting
Research Team
M
Mariana Colonna, Bioch
A
Ana Perez
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here