Therapeutic Orientation Test in Thrombotic Microangiopathy

NCT ID: NCT04777435

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-03

Study Completion Date

2027-04-03

Brief Summary

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Haemolytic and Uraemic Syndrome (HUS) is a serious disease requiring rapid diagnosis and management. The atypical HUS diagnosis has been greatly improved by anti-CS antibody (Eculizumab) wich block alternative complement pathway activation. To rise treatment success, Eculizumab introduction should be as early as possible. In some secondary HUS (infection, drugs…) complement is also involved as "second-hit".

To date, there is no tool to confirm complement involvement in a HUS at diagnosis stage. This study suggest to evaluate a therapeutic orientation test, in order to determine the complement implication in HUS diagnosis. The test evaluates the complement deposits on endothelial cell surface in vitro, compared to a normal human serum.

In order to determine the test performance, first the positive or negative results will be compared to the HUS clinical evolution, treated or not by the clinician with Eculizumab. Second, the test results will be compared to the presence of alternative complement pathway regulation abnormalities.

Detailed Description

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Conditions

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Thrombotic Micro-angiopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with Thrombotic micro-angiopathy

Group Type EXPERIMENTAL

Therapeutic orientation test for TMA

Intervention Type DIAGNOSTIC_TEST

Therapeutic orientation test for TMA performed on blood sample at inclusion, first visit at 1 month and last visit at 6 months.

Interventions

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Therapeutic orientation test for TMA

Therapeutic orientation test for TMA performed on blood sample at inclusion, first visit at 1 month and last visit at 6 months.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Bordeaux

Bordeaux, , France

Site Status RECRUITING

Site Médipôle Cabestany

Cabestany, , France

Site Status NOT_YET_RECRUITING

Centre Nephrocare Castelnau-le-Lez

Castelnau-le-Lez, , France

Site Status NOT_YET_RECRUITING

CHU de Grenoble

Grenoble, , France

Site Status RECRUITING

CHU de Lille

Lille, , France

Site Status RECRUITING

CHU de Limoges

Limoges, , France

Site Status RECRUITING

APHM-Hôpital de la Conception

Marseille, , France

Site Status RECRUITING

Montpellier University Hospital

Montpellier, , France

Site Status RECRUITING

CHU de Nantes

Nantes, , France

Site Status RECRUITING

HPGN- Narbonne

Narbonne, , France

Site Status NOT_YET_RECRUITING

CHU de Nice

Nice, , France

Site Status RECRUITING

CHU de Nîmes

Nîmes, , France

Site Status RECRUITING

APHP-Hôpital Tenon

Paris, , France

Site Status RECRUITING

Hôpital Paris Necker

Paris, , France

Site Status RECRUITING

CH de Perpignan

Perpignan, , France

Site Status RECRUITING

CHU de Poitiers

Poitiers, , France

Site Status RECRUITING

CHU de Rouen

Rouen, , France

Site Status RECRUITING

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

CHU de Toulouse

Toulouse, , France

Site Status RECRUITING

CHRU Tours

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Moglie LE QUNITREC-DONNETTE, Professor

Role: CONTACT

467330996 ext. +33

Facility Contacts

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COUZI Lionel, MD

Role: primary

DECOURT Alexandre, MD

Role: primary

JUGANT Sébastien, MD

Role: primary

ROSTAING Lionel, MD

Role: primary

PROVOT François, MD

Role: primary

MUGNIER Clovis, MD

Role: primary

JOURDE-CHICHE Noémie, MD

Role: primary

Moglie LE QUINTREC-DONNETTE, Pr

Role: primary

VILLE Simon, MD

Role: primary

COLDEFY Olivier, MD

Role: primary

ESNAULT Vincent, MD

Role: primary

MORANNE Olivier, MD

Role: primary

MESNARD Laurent, MD

Role: primary

SERVAIS Aude, MD

Role: primary

CANET Sébastien, MD

Role: primary

BRIDOUX Frank, MD

Role: primary

GUERROT Dominique, MD

Role: primary

CAILLARD OHLMANN Sophie, MD

Role: primary

RIBES David, MD

Role: primary

HALIMI Jean-Michel, MD

Role: primary

Other Identifiers

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RECHMPL19_0075

Identifier Type: -

Identifier Source: org_study_id

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