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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Thrombotic Micro-angiopathy Diagnostic Test: Therapeutic orientation test for TMA Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Moglie LE QUNITREC-DONNETTE, Professor 467330996 ext +33 m-lequintrec-donnette@chu-montpellier.fr

Locations
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France
Montpellier University Hospital Recruiting
Montpellier, France
Contact: Moglie LE QUINTREC-DONNETTE, Pr         
Sponsors and Collaborators
University Hospital, Montpellier
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04777435    
Other Study ID Numbers: RECHMPL19_0075
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Nephrology
Complement
Thrombotic micro-angiopathy
Diagnostic
Haemolytic and Uraemic Syndrome
Additional relevant MeSH terms:
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Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases