NCT04777435

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Apr 2021Apr 2027

First Submitted

Initial submission to the registry

February 19, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 3, 2021

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2027

Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

5.5 years

First QC Date

February 19, 2021

Last Update Submit

July 18, 2025

Conditions

Thrombotic Micro-angiopathy

Keywords

NephrologyComplementThrombotic micro-angiopathyDiagnosticHaemolytic and Uraemic Syndrome

Outcome Measures

Primary Outcomes (2)

  • Therapeutic orientation test sensitivity

    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

    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 Outcomes (1)

  • Untreated test positive patients

    Through study completion, an average of 3 years.

Study Arms (1)

Patients with Thrombotic micro-angiopathy

EXPERIMENTAL
Diagnostic Test: Therapeutic orientation test for TMA

Interventions

Therapeutic orientation test for TMADIAGNOSTIC_TEST

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

Patients with Thrombotic micro-angiopathy

Eligibility Criteria

AgeUp to 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • TMA with:
  • mechanic haemolytic anemia, undetectable haptoglobin, LDH\>1.5\*LNS
  • thrombopenia
  • acute kidney injury TMA on native kidney or in post-transplantation.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

CHU de Bordeaux

Bordeaux, France

RECRUITING

Site Médipôle Cabestany

Cabestany, France

NOT YET RECRUITING

Centre Nephrocare Castelnau-le-Lez

Castelnau-le-Lez, France

NOT YET RECRUITING

CHU de Grenoble

Grenoble, France

RECRUITING

CHU de Lille

Lille, France

RECRUITING

CHU de Limoges

Limoges, France

RECRUITING

APHM-Hôpital de la Conception

Marseille, France

RECRUITING

Montpellier University Hospital

Montpellier, France

RECRUITING

CHU de Nantes

Nantes, France

RECRUITING

HPGN- Narbonne

Narbonne, France

NOT YET RECRUITING

CHU de Nice

Nice, France

RECRUITING

CHU de Nîmes

Nîmes, France

RECRUITING

APHP-Hôpital Tenon

Paris, France

RECRUITING

Hôpital Paris Necker

Paris, France

RECRUITING

CH de Perpignan

Perpignan, France

RECRUITING

CHU de Poitiers

Poitiers, France

RECRUITING

CHU de Rouen

Rouen, France

RECRUITING

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

RECRUITING

CHU de Toulouse

Toulouse, France

RECRUITING

CHRU Tours

Tours, France

RECRUITING

MeSH Terms

Conditions

DiseaseHemolysis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Moglie LE QUNITREC-DONNETTE, Professor

CONTACT

467330996m-lequintrec-donnette@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2021

First Posted

March 2, 2021

Study Start

April 3, 2021

Primary Completion (Estimated)

October 3, 2026

Study Completion (Estimated)

April 3, 2027

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations

FR(20)