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Can aHUS patients safely stop eculizumab? algorithm put to the test

NCT ID NCT02574403

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Atypical hemolytic uremic syndrome (aHUS) is a rare disease that damages the kidneys by causing blood clots in small vessels. The drug eculizumab blocks the complement system and has greatly reduced kidney failure, but doctors do not know how long patients should stay on it. This study tests an algorithm-based plan to stop eculizumab in children and adults with aHUS, then follows them for two years to see how many relapse. The goal is to learn whether carefully selected patients can safely discontinue treatment.

What this could mean

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

Active substance
eculizumab, a drug that blocks part of the immune system's complement cascade
What this could lead to
If the algorithm works, some people with aHUS could stop lifelong eculizumab infusions and avoid their risks and costs while keeping their kidneys safe.
What could go wrong
Stopping eculizumab may trigger a dangerous relapse of aHUS, and the algorithm might not reliably predict who can safely stop. The study is small and open-label, so results may not apply to everyone.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

58 people

The number who actually took part.

Started

Nov 2015

Finished

Dec 2019

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

3 years and older

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: 1. Children and adults under eculizumab treatment for aHUS (initial episode or relapse) defined by at least two of the following: thrombocytopenia (platelet count \< 150 G/L), mechanical hemolytical anaemia (Hb \< 10 g:dl, LDH \> upper limit of normal, undetectable haptoglobin, presence of schizocytes on blood smear), acute kidney injury (serum creatinine and/or proteinuria/creatininuria \> upper limit of normal for age or an increase \> 15% compared to baseline levels ) 2. Patients not requiring dialysis. 3. Adults: HUS remission and normal or stabilized renal function under eculizumab treatment since at least 6 months (3 months in patients with MCP mutations) 4. Children: age \> 3 years at eculizumab withdrawal; HUS remission and normal renal function under eculizumab treatment since at least 3 months in children with isolated MCP mutation, at least 6 months in children with complement mutation other than MCP. Exclusion Criteria: 1. Patients on dialysis. 2. Women treated with eculizumab starting or planning a pregnancy. Pregnancy including the post-partum period is high-risk periods for the occurrence of aHUS. 3. Patients who did not give informed consent. 4. Patients under protection of a judicial authority Patients can be enrolled in the study within ten weeks after Eculizumab stop.

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Conditions

The condition(s) this trial relates to.

atypical hemolytic-uremic syndrome

As listed by the trial registrant

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

Atypical hemolytic uremic syndrome

Contacts and locations

Locations

  • AP-HM

    Marseille, France

  • BICHAT

    Paris, France

  • CH Alpes Léman

    Sallanches, France

  • CH Dijon

    Dijon, France

  • CH Metz Thionville

    Metz, France

  • CH métropole Savoie

    Chambéry, France

  • CHRU Lille

    Lille, France

  • CHU Amiens

    Amiens, France

  • CHU Bordeaux

    Bordeaux, France

  • CHU Caen

    Caen, France

  • CHU Montpellier

    Montpellier, France

  • CHU Nantes

    Nantes, France

  • CHU Nice

    Nice, France

  • CHU Rouen

    Rouen, France

  • CHU Strasbourg

    Strasbourg, France

  • CHU lyon

    Lyon, France

  • CHU toulouse

    Toulouse, France

  • Ch Le Mans

    Le Mans, France

  • Hopital FOCH

    Suresnes, France

  • Hopital Necker

    Paris, France

  • Hopital Tenon

    Paris, France

  • Hôpital Européen Georges Pompidou

    Paris, France

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