An interventional study of Therapeutic orientation test for TMA in Thrombotic Micro-angiopathy, sponsored by University Hospital, Montpellier. Completed at 20 sites in France. Open to participants aged Up to 90 Years. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic
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.
University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
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TMA with:
Exclusion Criteria:
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.
Therapeutic orientation test sensitivity
The proportion of patients testing positive among those receiving a relevant Eculizumab treatment ( TMA resolution with treatment or presence of abnormalities in alternative complement pathway.
Time frame: Through study completion, an average of 3 years.
Therapeutic orientation test specificity
The proportion of patients testing negative among patients who did not receive Eculizumab treatment.(TMA resolution without treatment or therapeutic failure with Eculizumab).
Time frame: Through study completion, an average of 3 years.
Untreated test positive patients
The proportion of patients with positive test but untreated by Eculizumab, and who therefore could have benefited from treatment.
Time frame: Through study completion, an average of 3 years.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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