Actively Recruiting

Phase Not Applicable
Age: 0 - 90Years
All Genders
NCT04777435

Therapeutic Orientation Test in Thrombotic Microangiopathy

Led by University Hospital, Montpellier · Updated on 2025-07-23

100

Participants Needed

20

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Therapeutic Orientation Test in Thrombotic Microangiopathy

Who Can Participate

Age: 0 - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of thrombotic microangiopathy (TMA) with mechanical hemolytic anemia, undetectable haptoglobin, and LDH greater than 1.5 times the normal limit
  • Presence of thrombocytopenia
  • Acute kidney injury due to TMA affecting native kidney or post-transplantation
Not Eligible

You will not qualify if you...

  • Disseminated intravascular coagulation (DIVC) patients
  • Plasma exchange treatment within 1 month before sample collection
  • Treatment with Eculizumab before sample collection
  • Lack of consent to participate
  • Not covered by social security
  • Pregnancy or breastfeeding
  • Patient under legal guardianship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 20 locations

1

CHU de Bordeaux

Bordeaux, France

Actively Recruiting

2

Site Médipôle Cabestany

Cabestany, France

Not Yet Recruiting

3

Centre Nephrocare Castelnau-le-Lez

Castelnau-le-Lez, France

Not Yet Recruiting

4

CHU de Grenoble

Grenoble, France

Actively Recruiting

5

CHU de Lille

Lille, France

Actively Recruiting

6

CHU de Limoges

Limoges, France

Actively Recruiting

7

APHM-Hôpital de la Conception

Marseille, France

Actively Recruiting

8

Montpellier University Hospital

Montpellier, France

Actively Recruiting

9

CHU de Nantes

Nantes, France

Actively Recruiting

10

HPGN- Narbonne

Narbonne, France

Not Yet Recruiting

11

CHU de Nice

Nice, France

Actively Recruiting

12

CHU de Nîmes

Nîmes, France

Actively Recruiting

13

APHP-Hôpital Tenon

Paris, France

Actively Recruiting

14

Hôpital Paris Necker

Paris, France

Actively Recruiting

15

CH de Perpignan

Perpignan, France

Actively Recruiting

16

CHU de Poitiers

Poitiers, France

Actively Recruiting

17

CHU de Rouen

Rouen, France

Actively Recruiting

18

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Actively Recruiting

19

CHU de Toulouse

Toulouse, France

Actively Recruiting

20

CHRU Tours

Tours, France

Actively Recruiting

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Research Team

M

Moglie LE QUNITREC-DONNETTE, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Therapeutic Orientation Test in Thrombotic Microangiopathy | DecenTrialz