Hemolytic-Uremic SyndromePhase 3NCT06389474
Efficacy of INM004 in Children With STEC-HUS
A Phase 3 study testing INM004 in people with Hemolytic-Uremic Syndrome, run by Inmunova S.A. at 52 sites in 9 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 9 months to 17 years
- Conditions the study is for
- Hemolytic-Uremic Syndrome
- What is being tested?
- INM004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 52 sitesin 9 countries
- Study dates
- 5 Oct 2024to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥ 9 months and < 18 years at the time of randomization.
- In addition, only for subjects < 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.
Show all 19Show fewer
- 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.
- Subjects who have already had menarche must have a negative pregnancy test.
Who cannot join
- 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).
Show all 18Show fewer
- Any other acute or chronic medical condition that, in the opinion of the investigator, may interfere with the evaluation of the efficacy 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).
Trial locations and contacts
52 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
Ana Perez contact
52 sites in 9 countries
Argentina25 sites, 18 recruiting
- Not yet recruiting
Hospital Interzonal Dr. José Penna
Bahía Blanca, Buenos Aires, 8000
- Not yet recruiting
Hospital Penna
Bahía Blanca, Buenos Aires
- Active, not recruiting
Sanatorio Güemes
Buenos Aires, Buenos Aires F.D., 1188
- Recruiting
Hospital de Pediatría S.A.M.I.C. "Prof. Dr. Juan P. Garrahan"
Buenos Aires, Buenos Aires F.D., 1245
- Active, not recruiting
Hospital General de Niños Pedro de Elizalde
Buenos Aires, Buenos Aires F.D., 1270
- Active, not recruiting
Sanatorio Anchorena
CABA, Buenos Aires F.D., 1425
- Active, not recruiting
Clínica Zabala
Ciudad Autonoma de Buenos Aire
- Recruiting
Hospital de Niños Dr. Ricardo Gutierrez
Ciudad Autonoma de Buenos Aire
- Recruiting
Hospital Privado Centro Médico de Córdoba
Córdoba, Córdoba Province, 5016
- Recruiting
Hospital de Niños de la Santísima Trinidad
Córdoba, Córdoba Province
- Withdrawn
Sanatorio Allende
Córdoba
- Recruiting
Hospital de niños Sor María Ludovica
La Plata, Buenos Aires, 1900
- Recruiting
Clinica del niño y la madre
Mar del Plata, Buenos Aires, 7600
- Recruiting
Hospital Interzonal Especializado Materno Infantil Don Victorio Tetamanti
Mar del Plata, Buenos Aires
- Recruiting
Hospital Pediátrico Dr. Humberto Notti
Mendoza, Mendoza Province
- Suspended
Clínica Pediátrica San Lucas
Neuquén, Neuquén Province, 8300
- Not yet recruiting
Sanatorio de la Trinidad Ramos Mejia
Ramos Mejía, Buenos Aires
- Recruiting
Hospital "San Antonio de Padua" Río Cuarto
Río Cuarto, Córdoba Province, 5806
- Recruiting
Hospital de Niños Zona Norte "Dr. Roberto M. Carra"
Rosario, Santa Fe Province, 2013
- Recruiting
Sanatorio de Niños
Rosario, Santa Fe Province
- Recruiting
Hospital Público Materno Infantil
Salta, Salta Province, 4400
- Not yet recruiting
Hospital El Cruce
San Juan Bautista, Buenos Aires
- Recruiting
Hospital Pediátrico San Luis
San Luis, San Luis Province, 5700
- Active, not recruiting
Hospital De Clínicas Pte. Nicolás Avellaneda
San Miguel de Tucumán, Tucumán Province, 4001
- Recruiting
Hospital Teodoro J. Schestakow
San Rafael, Mendoza Province, 5600
France8 sites, 4 recruiting
- Active, not recruiting
CHU De Bordeaux
Bordeaux
- Recruiting
Hospices Civils De Lyon - Hopital Femme Mere Enfant
Lyon
- Active, not recruiting
Centre Hospitalier Universitaire De Montpellier
Montpellier
- Not yet recruiting
CHU Nantes
Nantes
- Active, not recruiting
Hospital Necker Enfants Malades
Paris
- Recruiting
Robert Debre University Hospital
Paris
- Active, not recruiting
Trousseau Hospital
Paris
- Not yet recruiting
CHU Rouen
Rouen
Italy5 sites, 5 recruiting
- Recruiting
University Hospital Consorziale Policlinico
Bari
- Not yet recruiting
IRCCS Sant'Orsola
Bologna
- Recruiting
Istituto Gianina Gaslini
Genova
- Recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan
- Not yet recruiting
Azienda Ospedale Università
Padova
Germany3 sites, 3 recruiting
- Not yet recruiting
Charité - Universitätsmedizin Berlin
Berlin
- Not yet recruiting
University Hospital Cologne AöR
Cologne
- Recruiting
Universitaetsklinikum Heidelberg AöR
Heidelberg
Romania3 sites, 3 recruiting
- Not yet recruiting
Spitalul Clinic de Urgenta pentru Copii Marie Sklodowska Curie
Bucharest
- Recruiting
Spitalul Clinic De Urgenta Pentru Copii Cluj-Napoca
Cluj-Napoca
- Not yet recruiting
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu
Timișoara
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario De Cruces
Barakaldo
- Recruiting
Hospital Infantil Universitario Niño Jesus
Madrid
- Recruiting
Hospital Universitario 12 De Octubre
Madrid
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Bristol Royal Hospital for Children
Bristol
- Recruiting
Royal Hospital for Sick Children
Glasgow, G51 4TF
- Not yet recruiting
Great Ormon Street Hospital for Children
London
Belgium1 site
- Active, not recruiting
Cliniques universitaires Saint-Luc
Brussels
About this study
Official title: 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.
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).
Read the detailed description
The primary objective will be to evaluate the efficacy of INM004, added to the standard of care, as a treatment for STEC-HUS in the amelioration of renal function.
Secondary objectives
- To evaluate the efficacy of INM004 in the reduction of mortality.
- To evaluate the efficacy of INM004 in the prevention and reduction of extrarenal complications.
- To evaluate the efficacy of INM004 in the improvement of TMA laboratory parameters.
- To evaluate the efficacy of INM004 in the reduction of hospital stay days.
- To evaluate the safety of INM004
- To evaluate the pharmacokinetics of INM004
- To evaluate the kinetics of Stx
- Conditions
- Hemolytic-Uremic Syndrome
- Being tested
- INM004, Placebo
- Keywords
- STEC-HUS, Typical Hemolytic Uremic Syndrome, Diarrhea asociated-Hemolytic Uremic Syndrome, Shiga toxin-producing Escherichia coli, Shiga toxin
- Medical subject headings
- Hemolytic-Uremic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INM004Biological
Also called Active
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
PlaceboOther
Also called Control
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
| Study group | Role | What they receive |
|---|---|---|
| INM004 | Experimental | Two doses of Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab´)2 fragment at a dosage of 4 mg/kg of body weight, 24 hours apart. Receives: Biological: INM004 |
| Placebo | Placebo comparator | Two doses of saline solution, 24 hours apart. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (5)
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.
Measured: 90 days
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).
Measured: 90 days
Dialysis longer than 10 days
Proportion of dialyzed subjects requiring more than 10 days of dialysis
Measured: 90 days
Dialysis requirement
Proportion of subjects requiring dialysis after 24 hours post-randomization
Measured: 90 days
Mortality
Proportion of subjects who die from any cause.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start5 Oct 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemolytic-Uremic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adaptive design. IA will be done when approximately 50% of the enrollment is reached and the participants have completed 28 days of follow-up. This analysis will not be blinded and will be carried out to declare futility or re-estimate the sample size. The re-estimation of the sample size will allow a maximum of 300 randomized subjects in total, but a reduction in the initial item size of 220 subjects is not expected. In case of re-estimating the sample size, the smallest sample size under 300 will be selected, which allows a power of ≥ 80%. %. If with 300 subjects, a power of 80% is not reached, but it is ≥ 50%, then the sample size is re-estimated to 300 subjects, as long as the conditional power of the IA is ≥ 50% (promising results)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inmunova S.A.
- Sponsor type
- University, hospital or other
- Collaborators
- Exeltis, Chemo Research, Linical, KLIXAR
- Responsible party
- Sponsor
- Investigators
- Santiago Sanguineti, Ph.D, Study director, Inmunova S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389474
- Sponsor's protocol ID
- CT-INM004-04
- Status last verified
- Jan 2026
- First submitted
- 25 Apr 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06389474
- Acronym / sponsor ID
- CT-INM004-04
- Conditions
- Hemolytic-Uremic Syndrome
- Keywords
- STEC-HUS, Typical Hemolytic Uremic Syndrome, Diarrhea asociated-Hemolytic Uremic Syndrome, Shiga toxin-producing Escherichia coli, Shiga toxin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Inmunova S.A.University, hospital or other
- Collaborators
- Exeltis, Chemo Research, Linical, KLIXAR
- Study start
- 5 Oct 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The primary objective will be to evaluate the efficacy of INM004, added to the standard of care, as a treatment for STEC-HUS in the amelioration of renal function.
Secondary objectives
- To evaluate the efficacy of INM004 in the reduction of mortality.
- To evaluate the efficacy of INM004 in the prevention and reduction of extrarenal complications.
- To evaluate the efficacy of INM004 in the improvement of TMA laboratory parameters.
- To evaluate the efficacy of INM004 in the reduction of hospital stay days.
- To evaluate the safety of INM004
- To evaluate the pharmacokinetics of INM004
- To evaluate the kinetics of Stx
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Adaptive design. IA will be done when approximately 50% of the enrollment is reached and the participants have completed 28 days of follow-up. This analysis will not be blinded and will be carried out to declare futility or re-estimate the sample size. The re-estimation of the sample size will allow a maximum of 300 randomized subjects in total, but a reduction in the initial item size of 220 subjects is not expected. In case of re-estimating the sample size, the smallest sample size under 300 will be selected, which allows a power of ≥ 80%. %. If with 300 subjects, a power of 80% is not reached, but it is ≥ 50%, then the sample size is re-estimated to 300 subjects, as long as the conditional power of the IA is ≥ 50% (promising results)
| Arm | Type | Receives |
|---|---|---|
| INM004 | Experimental | Biological: INM004Two doses of Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab´)2 fragment at a dosage of 4 mg/kg of body weight, 24 hours apart. |
| Placebo | Placebo comparator | Other: PlaceboTwo doses of saline solution, 24 hours apart. |
Who may qualify
- Ages
- 9 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- Age ≥ 9 months and < 18 years at the time of randomization.
- In addition, only for subjects < 1 year and ≥ 15 years, confirmation of STEC infection determined by:
- 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:
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INM004Also: ActiveTwo 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 | Biological | INM004 |
| PlaceboAlso: ControlTwo 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 | Other | Placebo |
Primary outcome
Time to recovery of renal function during the acute phase
Time frame: 28 days
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.
5 secondary outcomes
Short-term recovery of renal function
Time frame: 90 days
MAKE 90
Time frame: 90 days
Dialysis longer than 10 days
Time frame: 90 days
Dialysis requirement
Time frame: 90 days
Mortality
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
Related trials for Hemolytic-Uremic Syndrome
Active, not recruitingPhase 3
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Atypical Hemolytic Uremic Syndrome
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
Atypical Hemolytic Uremic Syndrome(aHUS)
Active, not recruitingPhase 3
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Atypical Hemolytic Uremic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana Perez contact
Santiago Sanguineti, Ph.D study director
Inmunova S.A.
52 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing INM004 in people with Hemolytic-Uremic Syndrome, run by Inmunova S.A. at 52 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Argentina, France, Italy, Germany, Romania and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariana Colonna, Bioch (+541120331455 ext. 6184, mcolonna@inmunova.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recovery of renal function during the acute phase (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.