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RECRUITING
NCT04777435
NA

Therapeutic Orientation Test in Thrombotic Microangiopathy

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

Any - 90 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2021-04-03

Completion Date

2027-04-03

Last Updated

2025-07-23

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

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.

Locations (20)

CHU de Bordeaux

Bordeaux, France

Site Médipôle Cabestany

Cabestany, France

Centre Nephrocare Castelnau-le-Lez

Castelnau-le-Lez, France

CHU de Grenoble

Grenoble, France

CHU de Lille

Lille, France

CHU de Limoges

Limoges, France

APHM-Hôpital de la Conception

Marseille, France

Montpellier University Hospital

Montpellier, France

CHU de Nantes

Nantes, France

HPGN- Narbonne

Narbonne, France

CHU de Nice

Nice, France

CHU de Nîmes

Nîmes, France

APHP-Hôpital Tenon

Paris, France

Hôpital Paris Necker

Paris, France

CH de Perpignan

Perpignan, France

CHU de Poitiers

Poitiers, France

CHU de Rouen

Rouen, France

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

CHU de Toulouse

Toulouse, France

CHRU Tours

Tours, France