Therapeutic Orientation Test in Thrombotic Microangiopathy (TOTEM)

January 25, 2024 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • CHU de Bordeaux
        • Contact:
          • COUZI Lionel, MD
        • Principal Investigator:
          • COUZI Lionel
        • Principal Investigator:
          • HARAMBAT Jérôme
      • Cabestany, France
        • Not yet recruiting
        • Site Médipôle Cabestany
        • Contact:
          • DECOURT Alexandre, MD
        • Principal Investigator:
          • DECOURT Alexandre, MD
      • Castelnau-le-Lez, France
        • Not yet recruiting
        • Centre Nephrocare Castelnau-le-Lez
        • Contact:
          • JUGANT Sébastien, MD
        • Principal Investigator:
          • JUGANT Sébastien, MD
      • Grenoble, France
        • Recruiting
        • CHU de Grenoble
        • Contact:
          • ROSTAING Lionel, MD
        • Principal Investigator:
          • ROSTAING Lionel, MD
      • Lille, France
        • Recruiting
        • Chu De Lille
        • Contact:
          • PROVOT François, MD
        • Principal Investigator:
          • PROVOT François, MD
        • Principal Investigator:
          • NOVO Robert, MD
      • Limoges, France
        • Recruiting
        • CHU de LIMOGES
        • Contact:
          • EL OUAFI Zhour, MD
        • Principal Investigator:
          • EL OUAFI Zhour, MD
        • Principal Investigator:
          • GUIGONIS Vincent, MD
      • Marseille, France
        • Not yet recruiting
        • APHM-Hôpital de la Conception
        • Contact:
          • JOURDE-CHICHE Noémie, MD
        • Principal Investigator:
          • JOURDE-CHICHE Noémie, MD
      • Montpellier, France
        • Recruiting
        • Montpellier University Hospital
        • Contact:
          • Moglie LE QUINTREC-DONNETTE, Pr
      • Nantes, France
        • Recruiting
        • CHU de Nantes
        • Contact:
          • VILLE Simon, MD
        • Principal Investigator:
          • ROUSSEY Gwenaelle
        • Principal Investigator:
          • VILLE Simon
      • Narbonne, France
        • Not yet recruiting
        • HPGN- Narbonne
        • Contact:
          • COLDEFY Olivier, MD
        • Principal Investigator:
          • COLDEFY Olivier, MD
      • Nice, France
        • Recruiting
        • CHU de Nice
        • Contact:
          • ESNAULT Vincent, MD
        • Principal Investigator:
          • ESNAULT Vincent, MD
      • Nîmes, France
        • Recruiting
        • CHU de Nîmes
        • Contact:
          • MORANNE Olivier, MD
        • Principal Investigator:
          • MORANNE Olivier, MD
      • Paris, France
        • Not yet recruiting
        • Hopital Robert Debre
        • Contact:
          • KWON Theresa, MD
        • Principal Investigator:
          • KWON Theresa, MD
      • Paris, France
        • Not yet recruiting
        • APHP-Hôpital Tenon
        • Contact:
          • MESNARD Laurent, MD
        • Principal Investigator:
          • MESNARD Laurent, MD
      • Paris, France
        • Recruiting
        • Hôpital Paris Necker
        • Contact:
          • SERVAIS Aude, MD
        • Principal Investigator:
          • SERVAIS Aude, MD
        • Principal Investigator:
          • BOYER Olivia, MD
      • Perpignan, France
        • Recruiting
        • CH de Perpignan
        • Contact:
          • CANET Sébastien, MD
        • Principal Investigator:
          • CANET Sébastien, MD
      • Poitiers, France
        • Recruiting
        • CHU de Poitiers
        • Contact:
          • BRIDOUX Frank, MD
        • Principal Investigator:
          • BRIDOUX Frank, MD
      • Rouen, France
        • Recruiting
        • CHU de Rouen
        • Contact:
          • GUERROT Dominique, MD
        • Principal Investigator:
          • GUERROT Dominique, MD
        • Principal Investigator:
          • GRANGE Steven, MD
      • Strasbourg, France
        • Not yet recruiting
        • Hôpitaux Universitaires de Strasbourg
        • Contact:
          • CAILLARD OHLMANN Sophie, MD
        • Principal Investigator:
          • CAILLARD OHLMANN Sophie, MD
      • Toulouse, France
        • Recruiting
        • CHU de Toulouse
        • Contact:
          • RIBES David, MD
        • Principal Investigator:
          • DECRAMER Stéphane, MD
        • Principal Investigator:
          • RIBES David, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 3 years.
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).
Through study completion, an average of 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2021

Primary Completion (Estimated)

October 3, 2025

Study Completion (Estimated)

April 3, 2026

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (Actual)

March 2, 2021

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL19_0075

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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