Thrombotic Micro-angiopathyTOTEMNCT04777435
Therapeutic Orientation Test in Thrombotic Microangiopathy
A study testing Therapeutic orientation test for TMA in people with Thrombotic Micro-angiopathy, run by University Hospital, Montpellier at 20 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Thrombotic Micro-angiopathy
- What is being tested?
- Therapeutic orientation test for TMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 20 sitesFrance
- Study dates
- 3 Apr 2021to 13 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- TMA with:
- mechanic haemolytic anemia, undetectable haptoglobin, LDH>1.5*LNS
- thrombopenia
- acute kidney injury TMA on native kidney or in post-transplantation.
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
CHU de Bordeaux
Bordeaux
Site Médipôle Cabestany
Cabestany
Centre Nephrocare Castelnau-le-Lez
Castelnau-le-Lez
CHU de Grenoble
Grenoble
CHU de Lille
Lille
CHU de Limoges
Limoges
APHM-Hôpital de la Conception
Marseille
Montpellier University Hospital
Montpellier
CHU de Nantes
Nantes
HPGN- Narbonne
Narbonne
CHU de Nice
Nice
CHU de Nîmes
Nîmes
APHP-Hôpital Tenon
Paris
Hôpital Paris Necker
Paris
CH de Perpignan
Perpignan
CHU de Poitiers
Poitiers
CHU de Rouen
Rouen
Hôpitaux Universitaires de Strasbourg
Strasbourg
CHU de Toulouse
Toulouse
CHRU Tours
Tours
About this study
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.
- Conditions
- Thrombotic Micro-angiopathy
- Being tested
- Therapeutic orientation test for TMA
- Keywords
- Nephrology, Complement, Thrombotic micro-angiopathy, Diagnostic, Haemolytic and Uraemic Syndrome
- Medical subject headings
- Disease, Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Thrombotic micro-angiopathy | Experimental | Not described Receives: Diagnostic Test: Therapeutic orientation test for TMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Through study completion, an average of 3 years.
Secondary outcomes (1)
Untreated test positive patients
The proportion of patients with positive test but untreated by Eculizumab, and who therefore could have benefited from treatment.
Measured: Through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start3 Apr 2021
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombotic Micro-angiopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777435
- Sponsor's protocol ID
- RECHMPL19_0075
- Acronym
- TOTEM
- Status last verified
- May 2026
- First submitted
- 19 Feb 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Orientation Test in Thrombotic Microangiopathy
- ClinicalTrials.gov ID
- NCT04777435
- Acronym / sponsor ID
- TOTEM / RECHMPL19_0075
- Conditions
- Thrombotic Micro-angiopathy
- Keywords
- Nephrology, Complement, Thrombotic micro-angiopathy, Diagnostic, Haemolytic and Uraemic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 3 Apr 2021 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Thrombotic micro-angiopathy | Experimental | Diagnostic Test: Therapeutic orientation test for TMA |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- mechanic haemolytic anemia, undetectable haptoglobin, LDH>1.5*LNS
- thrombopenia
- acute kidney injury TMA on native kidney or in post-transplantation.
Key exclusion criteria (7 listed)
- DIVC patients
- plasma exchange during 1 month before sample collection
- treatment by Eculizumab before sample collection
- no consent
- not beneficiary of a social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic orientation test for TMATherapeutic orientation test for TMA performed on blood sample at inclusion, first visit at 1 month and last visit at 6 months. | Diagnostic test | Patients with Thrombotic micro-angiopathy |
Primary outcome
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).
1 secondary outcome
Untreated test positive patients
Time frame: Through study completion, an average of 3 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic orientation test for TMA in people with Thrombotic Micro-angiopathy, run by University Hospital, Montpellier at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic orientation test sensitivity (time frame: Through study completion, an average of 3 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.