Therapeutic Orientation Test in Thrombotic Microangiopathy
NCT ID: NCT04777435
Last Updated: 2025-07-23
Study Results
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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RECRUITING
NA
100 participants
INTERVENTIONAL
2021-04-03
2027-04-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients with Thrombotic micro-angiopathy
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.
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.
Eligibility Criteria
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Inclusion Criteria
* mechanic haemolytic anemia, undetectable haptoglobin, LDH\>1.5\*LNS
* thrombopenia
* acute kidney injury TMA on native kidney or in post-transplantation.
Exclusion Criteria
* 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
90 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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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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