Test for diagnosing Thrombotic Microangiopathy

Therapeutic Orientation Test in Thrombotic Microangiopathy

This study is testing a new test to see if it can help diagnose a serious condition called Haemolytic and Uraemic Syndrome (HUS) by checking for certain markers in the blood, which could lead to better treatment outcomes for patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: N/A to 90 Years
• Sex: All
• Sponsor: University Hospital, Montpellier (other)
• Drugs / interventions: Eculizumab
• Locations: 20 sites (Bordeaux and 19 other locations)
• Trial ID: NCT04777435 on ClinicalTrials.gov

What this trial studies

This study evaluates a new therapeutic orientation test designed to confirm the involvement of the complement system in diagnosing Haemolytic and Uraemic Syndrome (HUS), a serious condition requiring prompt treatment. The test assesses complement deposits on endothelial cells in vitro and compares these results to clinical outcomes in patients treated with Eculizumab. By identifying complement involvement early, the study aims to improve treatment success rates for patients with HUS. The performance of the test will be validated against clinical evolution and the presence of alternative complement pathway activation.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with Thrombotic Microangiopathy exhibiting symptoms such as mechanical hemolytic anemia and acute kidney injury.

Not a fit: Patients with conditions like DIVC or those who have received Eculizumab treatment prior to sample collection may not benefit from this study.

Why it matters

Potential benefit: If successful, this test could lead to earlier and more accurate diagnoses of HUS, improving treatment outcomes for patients.

How similar studies have performed: While this approach is novel in the context of HUS diagnosis, similar studies evaluating complement involvement in other conditions have shown promising results.

Eligibility criteria

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

Where this trial is running

Bordeaux and 19 other locations

• CHU de Bordeaux — Bordeaux, France (RECRUITING)
• Site Médipôle Cabestany — Cabestany, France (NOT_YET_RECRUITING)
• Centre Nephrocare Castelnau-le-Lez — Castelnau-le-Lez, France (NOT_YET_RECRUITING)
• CHU de Grenoble — Grenoble, France (RECRUITING)
• CHU de Lille — Lille, France (RECRUITING)
• CHU de Limoges — Limoges, France (RECRUITING)
• APHM-Hôpital de la Conception — Marseille, France (RECRUITING)
• Montpellier University Hospital — Montpellier, France (RECRUITING)
• CHU de Nantes — Nantes, France (RECRUITING)
• HPGN- Narbonne — Narbonne, France (NOT_YET_RECRUITING)
• CHU de Nice — Nice, France (RECRUITING)
• CHU de Nîmes — Nîmes, France (RECRUITING)
• APHP-Hôpital Tenon — Paris, France (RECRUITING)
• Hôpital Paris Necker — Paris, France (RECRUITING)
• CH de Perpignan — Perpignan, France (RECRUITING)
• CHU de Poitiers — Poitiers, France (RECRUITING)
• CHU de Rouen — Rouen, France (RECRUITING)
• Hôpitaux Universitaires de Strasbourg — Strasbourg, France (RECRUITING)
• CHU de Toulouse — Toulouse, France (RECRUITING)
• CHRU Tours — Tours, France (RECRUITING)

Study contacts

• Study coordinator: Moglie LE QUNITREC-DONNETTE, Professor

Conditions: Thrombotic Micro-angiopathy, Nephrology, Complement, Thrombotic micro-angiopathy, Diagnostic, Haemolytic and Uraemic Syndrome