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Therapeutic Orientation Test in Thrombotic Microangiopathy (TOTEM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 19, 2021
First Posted Date  ICMJE March 2, 2021
Last Update Posted Date February 3, 2023
Actual Study Start Date  ICMJE April 3, 2021
Estimated Primary Completion Date October 3, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2021)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2021)		 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Orientation Test in Thrombotic Microangiopathy
Official Title  ICMJE Therapeutic Orientation Test in Thrombotic Microangiopathy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Thrombotic Micro-angiopathy
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Patients with Thrombotic micro-angiopathy
Intervention: Diagnostic Test: Therapeutic orientation test for TMA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 25, 2021)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 3, 2024
Estimated Primary Completion Date October 3, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Moglie LE QUNITREC-DONNETTE, Professor 467330996 ext +33 m-lequintrec-donnette@chu-montpellier.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04777435
Other Study ID Numbers  ICMJE RECHMPL19_0075
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Montpellier
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Montpellier
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Montpellier
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP