Therapeutic Orientation Test in Thrombotic Microangiopathy (TOTEM)
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|ClinicalTrials.gov Identifier: NCT04777435|
Recruitment Status : Recruiting
First Posted : March 2, 2021
Last Update Posted : February 3, 2023
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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.
|Condition or disease||Intervention/treatment||Phase|
|Thrombotic Micro-angiopathy||Diagnostic Test: Therapeutic orientation test for TMA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapeutic Orientation Test in Thrombotic Microangiopathy|
|Actual Study Start Date :||April 3, 2021|
|Estimated Primary Completion Date :||October 3, 2023|
|Estimated Study Completion Date :||April 3, 2024|
|Experimental: Patients with Thrombotic micro-angiopathy||
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 [ Time Frame: Through study completion, an average of 3 years. ]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.
- Therapeutic orientation test specificity [ Time Frame: Through study completion, an average of 3 years. ]The proportion of patients testing negative among patients who did not receive Eculizumab treatment.(TMA resolution without treatment or therapeutic failure with Eculizumab).
- Untreated test positive patients [ Time Frame: Through study completion, an average of 3 years. ]The proportion of patients with positive test but untreated by Eculizumab, and who therefore could have benefited from treatment.
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|Ages Eligible for Study:||up to 90 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- mechanic haemolytic anemia, undetectable haptoglobin, LDH>1.5*LNS
- acute kidney injury TMA on native kidney or in post-transplantation.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04777435
|Contact: Moglie LE QUNITREC-DONNETTE, Professor||467330996 ext +email@example.com|
|Montpellier University Hospital||Recruiting|
|Contact: Moglie LE QUINTREC-DONNETTE, Pr|
|Responsible Party:||University Hospital, Montpellier|
|Other Study ID Numbers:||
|First Posted:||March 2, 2021 Key Record Dates|
|Last Update Posted:||February 3, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Haemolytic and Uraemic Syndrome
Blood Platelet Disorders