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OpenTrials
Completed

NCT Number: NCT04777435

Therapeutic Orientation Test in Thrombotic Microangiopathy

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.

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Key information

Conditions

Thrombotic Micro-angiopathy Disease Hemolysis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic orientation test for TMA

Diagnostic Test

Therapeutic orientation test for TMA performed on blood sample at inclusion, first visit at 1 month and last visit at 6 months.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: TOTEM

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2021
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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