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New blood test could speed up Life-Saving treatment for HUS patients

NCT ID NCT04777435

Diagnosis Sponsor: University Hospital, Montpellier 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new blood test designed to quickly determine whether the complement system is involved in a serious kidney condition called thrombotic microangiopathy (TMA). The test measures complement deposits on cells in a lab sample. Researchers compared test results to how patients actually responded to treatment. The goal is to help doctors decide sooner whether to use a powerful drug called Eculizumab. The study involved 100 participants and has already been completed.

What this could mean

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

Active substance
Therapeutic orientation test (blood test measuring complement deposits on endothelial cells)
What this could lead to
If successful, this test could help doctors quickly identify which patients with HUS need complement-blocking therapy, potentially improving treatment timing and outcomes.
What could go wrong
This is a small, completed diagnostic study (100 participants) that measures test accuracy against clinical judgment. The test may not be widely adopted or may not perform as well in larger, more diverse populations.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

Apr 2021

Finished

Apr 2026

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

Up to 90 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: TMA with: * mechanic haemolytic anemia, undetectable haptoglobin, LDH\>1.5\*LNS * thrombopenia * acute kidney injury TMA on native kidney or in post-transplantation. Exclusion Criteria: * DIVC patients * plasma exchange during 1 month before sample collection * treatment by Eculizumab before sample collection * no consent * not beneficiary of a social security * pregnancy or breastfeeding * patient Under guardianship

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Conditions

The condition(s) this trial relates to.

disease Hemolysis thrombotic microangiopathy

As listed by the trial registrant

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

Thrombotic micro-angiopathy

Contacts and locations

Locations

  • APHM-Hôpital de la Conception

    Marseille, France

  • APHP-Hôpital Tenon

    Paris, France

  • CH de Perpignan

    Perpignan, France

  • CHRU Tours

    Tours, France

  • CHU de Bordeaux

    Bordeaux, France

  • CHU de Grenoble

    Grenoble, France

  • CHU de Lille

    Lille, France

  • CHU de Limoges

    Limoges, France

  • CHU de Nantes

    Nantes, France

  • CHU de Nice

    Nice, France

  • CHU de Nîmes

    Nîmes, France

  • CHU de Poitiers

    Poitiers, France

  • CHU de Rouen

    Rouen, France

  • CHU de Toulouse

    Toulouse, France

  • Centre Nephrocare Castelnau-le-Lez

    Castelnau-le-Lez, France

  • HPGN- Narbonne

    Narbonne, France

  • Hôpital Paris Necker

    Paris, France

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, France

  • Montpellier University Hospital

    Montpellier, France

  • Site Médipôle Cabestany

    Cabestany, France