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Can a drug shorten dialysis for kids with a rare kidney disease?

NCT ID NCT02205541

Disease control Sponsor: University Hospital, Toulouse Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether the drug eculizumab (Soliris) can help children with a severe kidney condition called STEC-HUS recover faster. The trial gave 100 children either eculizumab or a placebo over several weeks. The main goal was to see if the drug reduces the number of days they need dialysis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
eculizumab (Soliris)
What this could lead to
If it works, this could provide the first proven treatment to shorten kidney dialysis and speed recovery in children with STEC-HUS.
What could go wrong
This is an early Phase 3 trial with only 100 children, and previous studies have shown mixed results. The drug may not reduce dialysis time or could cause side effects like infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

100 people

The number who actually took part.

Started

Jun 2015

Finished

Jun 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pediatric patient (1 month-18 years old) * Affected by STEC-HUS defined by : * Thrombocytopenia (\<150 000/mm3) * Mechanic hemolytic anemia (Hemoglobin \< 10g/dL, haptoglobin \<LLN, lactate dehydrogenase (LDH) \>upper limit of normal (ULN) and/or bilirubin \> ULN, presence of schizocytes) * ARF defined by an estimated Schwartz 2009 creatinin clearance \<75ml/min/1,73m² * With prodromal diarrhea and/or presence of an enterohemorrhagic strain of Escherichia Coli and/or identification of the Stx 1 or 2 genes in the stool sample or rectal swab * Written consent of the 2 parents * Female patients of childbearing potential must be practicing an effective, reliable and medically acceptable contraceptive regimen during the entire duration of the study and 5 months after the end of the participation. Exclusion Criteria: * Neonatal HUS * Malignancy * Known HIV infection * Pregnancy or lactation * Identified drug exposure-related HUS * Infection-related HUS * Known systemic lupus erythematosus or antiphospholipid antibody positivity or syndrome * Patient already enrolled in a drug trial * Patient with ongoing meningococcal infection * Patient affected by aHUS or family history of aHUS * STEC-HUS patient with severe multiorgan involvement at diagnostic: * Neurological involvement (seizures, coma, focal deficit) with signs of microangiopathy on cerebral Magnetic Resonance Imaging. * Cardiac involvement (cardiac failure, ischemic myocarditis, conduction or rhythm troubles) * Digestive involvement (severe pancreatitis defined by lipasemia\>500UI/L, severe hepatitis defined by transaminase \>x10ULN and/or prothrombin time\<60%, hemorrhagic colitis, bowel perforation, rectal prolapsus)

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Conditions

The condition(s) this trial relates to.

hemolytic-uremic syndrome Shiga toxin-associated hemolytic uremic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemolytic uremic syndrome of childhood

Contacts and locations

Locations

  • Anne de Bretagne University Hospital

    Rennes, 35056, France

  • Clocheville Hospital

    Tours, 37044, France

  • Jeanne de Flandre Hospital

    Lille, 59037, France

  • La Timone Hospital

    Marseille, France

  • Morvan Hospital

    Brest, 29609, France

  • Mother and Child Hospital

    Limoges, 87000, France

  • Mother and Child Hospital

    Nantes, 44000, France

  • Necker Hospital

    Paris, 75743, France

  • Pellegrin Hospital

    Bordeaux, 33000, France

  • Purpan Children Hospital

    Toulouse, 31059, France

  • Robert Debré Hospital

    Paris, 75019, France

  • Trousseau Hospital

    Paris, 75571, France

  • University Hospital

    Amiens, 80054, France

  • University Hospital

    Angers, 49100, France

  • University Hospital

    Besançon, 25030, France

  • University Hospital

    Grenoble, 60107, France

  • University Hospital

    Montpellier, 34295, France

  • Women, Mother and Child Hospital

    Lyon, 69500, France