BridgeMD
Tests treatment safety and results for Hemolytic-Uremic Syndrome
Official title Efficacy of INM004 in Children With STEC-HUS
ClinicalTrials.gov ID: NCT06389474
What this study is testing
What is INM004?
INM004 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hemolytic-uremic syndrome.
Also referred to as Active.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objectives of this study are to evaluate the efficacy, safety, and pharmacokinetics of INM004 in pediatric patients with Hemolytic Uremic Syndrome associated to infection by Shiga toxin-producing Escherichia coli (STEC-HUS).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 to 17
You may be able to join if
- Age ≥ 9 months and \< 18 years at the time of randomization.
- In addition, only for people \< 1 year and ≥ 15 years, confirmation of STEC infection determined by:
- Detection of generic Stx, Stx1, Stx2, or Stx1/Stx2 in stools by enzyme immunoassay (EIA); or
- Detection of stx, stx1, stx2, or stx1/stx2 genes in stools by Polymerase Chain Reaction (PCR); or
- Detection of specific anti-polysaccharide (IgM) antibodies in serum; or
You likely can't join if
- Start of dialysis within 48 hours prior to admission to the participating institution.
- More than 24 hours from diagnosis of STEC-HUS at the participating institution up to randomization.
- History of chronic/recurrent hemolytic anemia, thrombocytopenia, or CKD.
- Personal and/or family history of atypical HUS.
- Suspected HUS secondary to infectious processes other than gastrointestinal (e.g., Streptococcus pneumoniae, HIV).
- Suspected HUS secondary to other etiologies (e.g., drug-associated HUS, neoplasms, bone marrow or solid organ transplantation, autoimmune disorders).
See the full eligibility criteria
- Age ≥ 9 months and \< 18 years at the time of randomization.
- In addition, only for people \< 1 year and ≥ 15 years, confirmation of STEC infection determined by:
- Detection of generic Stx, Stx1, Stx2, or Stx1/Stx2 in stools by enzyme immunoassay (EIA); or
- Detection of stx, stx1, stx2, or stx1/stx2 genes in stools by Polymerase Chain Reaction (PCR); or
- Detection of specific anti-polysaccharide (IgM) antibodies in serum; or
- Fecal culture positive for E. coli O157 confirmed by serogroup-specific seroagglutination.
- Hospitalization at the participating institution.
- History of onset of diarrhea within 10 days prior to STEC-HUS diagnosis at the participating institution.
- Diagnosis of STEC-HUS defined as a subject with signs of renal damage, hemolysis, and platelet consumption:
- Signs of renal damage defined as:
- Serum creatinine value above the ULN for age and sex, and GFR below the LLN for age, sex, and height.
- Presence of hemolysis documented by:
- LDH levels above the ULN for age, and/or
- Presence of schistocytes in peripheral blood smear.
- Platelet consumption according to any of the following laboratory criteria:
- Peripheral blood platelet count \< 150 × 103/μL, and/or
- A ≥50% decrease in peripheral blood platelet count compared to a sample collected within the previous 24 hours.
- Informed consent form signed and dated by the subject or, the legal guardian(s), with the subject's assent as appropriate based on age and regulatory guidelines in the region.
- people who have already had menarche must have a negative pregnancy test.
- Start of dialysis within 48 hours prior to admission to the participating institution.
- More than 24 hours from diagnosis of STEC-HUS at the participating institution up to randomization.
- History of chronic/recurrent hemolytic anemia, thrombocytopenia, or CKD.
- Personal and/or family history of atypical HUS.
- Suspected HUS secondary to infectious processes other than gastrointestinal (e.g., Streptococcus pneumoniae, HIV).
- Suspected HUS secondary to other etiologies (e.g., drug-associated HUS, neoplasms, bone marrow or solid organ transplantation, autoimmune disorders).
- Any other acute or chronic medical condition that, in the opinion of the investigator, may interfere with the evaluation of the how well it works and/or safety of the study medication.
- History of: a) anaphylaxis of any kind; b) prior administration of equine serum (e.g., antivenom, anti-arachnid serum, anti-SARS-CoV-2 serum, etc.) or an allergic reaction from contact or exposure to horses.
- Pregnant or breastfeeding woman.
- Impossibility of hospitalization in the participating institution.
- Concurrent participation in another clinical trial or having participated in a clinical trial in the last 3 months.
- Severe malnutrition. Defined when the weight is three standard deviations below the median, according to height, age and sex as per WHO guidelines.
- Medical conditions that may affect kidney function or cause/enhance neurological symptoms or signs:
- Congenital or acquired anomalies that may affect functioning renal mass.
- Epilepsy or structural abnormalities of the brain that may increase the risk of seizures.
- Trisomy 21.
- Prematurity (born before 28 weeks gestation).
- Other (according to investigator criteria).
The study team makes the final eligibility decision.
Where it's taking place
- Bahía Blanca, Buenos Aires, Argentina
- La Plata, Buenos Aires, Argentina
- Mar del Plata, Buenos Aires, Argentina
- Ramos Mejía, Buenos Aires, Argentina
- San Juan Bautista, Buenos Aires, Argentina
- Buenos Aires, Buenos Aires F.D., Argentina
- CABA, Buenos Aires F.D., Argentina
- Córdoba, Córdoba Province, Argentina
- Río Cuarto, Córdoba Province, Argentina
- Mendoza, Mendoza Province, Argentina
- San Rafael, Mendoza Province, Argentina
- Neuquén, Neuquén Province, Argentina
- Salta, Salta Province, Argentina
- San Luis, San Luis Province, Argentina
- Rosario, Santa Fe Province, Argentina
- San Miguel de Tucumán, Tucumán Province, Argentina
- Ciudad Autonoma de Buenos Aire, Argentina
- Córdoba, Argentina
- Brussels, Belgium
- Bordeaux, France
+ 22 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 9 months to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bahía Blanca, Buenos Aires, Argentina; La Plata, Buenos Aires, Argentina; Mar del Plata, Buenos Aires, Argentina; Ramos Mejía, Buenos Aires, Argentina; San Juan Bautista, Buenos Aires, Argentina; Buenos Aires, Buenos Aires F.D., Argentina and 36 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.