Health TrialsbyHealthPanel

Efficacy of INM004 in Children With STEC-HUS

ConditionHemolytic-Uremic Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age9-17
SponsorInmunova S.A.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 9 months and < 18 years at the time of randomization.

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • INM004

    Biological/Vaccine

    Two doses of Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab´)2 fragments at a dosage of 4 mg/kg of body weight, 24 hours apart. Each vial contains 25 mg of protein/ml. Therefore, each subject must receive 0.16 ml/kg per dose. The vial volume will be reconstituted in a 100 ml (for subjects with a body weight of 20 kg or more) or 50 ml (for subjects under 20 kg of body weight) infusion bag. It will be administered as an intravenous infusion using an infusion pump over a period of 50 minutes. In subjects with a BMI over 30 kg/m2, infusion will be performed over a period of 100 minutes

  • Placebo

    Other intervention

    Two doses of placebo, 24 hours apart. The placebo solution has the same composition of excipients as INM004 without the active pharmaceutical ingredient, and its appearance is identical. Each subject must receive 0.16 ml/kg of placebo solution per dose. The vial volume will be reconstituted in a 100 ml (for subjects with a body weight of 20 kg or more) or 50 ml (for subjects under 20 kg of body weight) infusion bag. It will be administered as an intravenous infusion using an infusion pump over a period of 50 minutes. In subjects with a BMI over 30 kg/m2, infusion will be performed over a period of 100 minutes

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: INM004Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to recovery of renal function during the acute phase

Time (days) to achieve a glomerular filtration rate greater than or equal to the lower limit of normal (according to age, height, and sex) and a serum creatinine lower than or equal to the upper limit of normal (according to age and sex), both measured in the absence of dialysis.

Time frame
28 days

Secondary outcomes

1

Short-term recovery of renal function

Proportion of subjects with a glomerular filtration rate ≥ lower limit of normal (according to age, height and sex) and serum creatinine ≤ upper limit of normal (according to age and sex), both measured in the absence of dialysis.

Time frame
90 days
2

MAKE 90

Proportion of subjects meeting any of the following criteria at day 90: death, dialysis requirement after 24 hours post-randomization, dialysis of more than 10 days, or persistent decline in renal function (without recovery of glomerular filtration rate according to age, height, and sex).

Time frame
90 days
3

Dialysis longer than 10 days

Proportion of dialyzed subjects requiring more than 10 days of dialysis

Time frame
90 days
4

Dialysis requirement

Proportion of subjects requiring dialysis after 24 hours post-randomization

Time frame
90 days

Other outcomes

1

CKD Risk Assessment According to Kidney Disease Improving Global Outcomes (KDIGO) Categories

Proportion of subjects in each CKD category (low, medium, high, very high) according to GFR and albuminuria at day 90

Time frame
90 days
2

Evolution of renal function at 7 days (GFR_AUC1-7)

Area under the curve of glomerular filtration rate from Day 1 to Day 7

Time frame
7 days
3

Evolution of renal function at 28 days (GFR_AUC1-28)

Area under the curve of glomerular filtration rate from Day 1 to Day 28

Time frame
28 days
4

Evolution of renal function at 90 days (GFR_AUC1-90)

Area under the curve of glomerular filtration rate from Day 1 to Day 90

Time frame
90 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inmunova S.A.

Lead sponsor

Exeltis

Collaborator

Chemo Research

Collaborator

Linical

Collaborator

KLIXAR

Collaborator

Source ClinicalTrials.gov
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