Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-30 @ 7:38 AM
Study NCT ID:
NCT04777435
Status:
RECRUITING
Last Update Posted:
2025-07-23
First Post:
2021-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Orientation Test in Thrombotic Microangiopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}, {'id': 'D006461', 'term': 'Hemolysis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-04-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2021-02-19', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Therapeutic orientation test sensitivity', 'timeFrame': 'Through study completion, an average of 3 years.', 'description': '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.'}, {'measure': 'Therapeutic orientation test specificity', 'timeFrame': 'Through study completion, an average of 3 years.', 'description': 'The proportion of patients testing negative among patients who did not receive Eculizumab treatment.(TMA resolution without treatment or therapeutic failure with Eculizumab).'}], 'secondaryOutcomes': [{'measure': 'Untreated test positive patients', 'timeFrame': 'Through study completion, an average of 3 years.', 'description': 'The proportion of patients with positive test but untreated by Eculizumab, and who therefore could have benefited from treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nephrology', 'Complement', 'Thrombotic micro-angiopathy', 'Diagnostic', 'Haemolytic and Uraemic Syndrome'], 'conditions': ['Thrombotic Micro-angiopathy']}, 'descriptionModule': {'briefSummary': '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".\n\nTo 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTMA with:\n\n* mechanic haemolytic anemia, undetectable haptoglobin, LDH\\>1.5\\*LNS\n* thrombopenia\n* acute kidney injury TMA on native kidney or in post-transplantation.\n\nExclusion Criteria:\n\n* DIVC patients\n* plasma exchange during 1 month before sample collection\n* treatment by Eculizumab before sample collection\n* no consent\n* not beneficiary of a social security\n* pregnancy or breastfeeding\n* patient Under guardianship'}, 'identificationModule': {'nctId': 'NCT04777435', 'acronym': 'TOTEM', 'briefTitle': 'Therapeutic Orientation Test in Thrombotic Microangiopathy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Therapeutic Orientation Test in Thrombotic Microangiopathy', 'orgStudyIdInfo': {'id': 'RECHMPL19_0075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with Thrombotic micro-angiopathy', 'interventionNames': ['Diagnostic Test: Therapeutic orientation test for TMA']}], 'interventions': [{'name': 'Therapeutic orientation test for TMA', 'type': 'DIAGNOSTIC_TEST', 'description': 'Therapeutic orientation test for TMA performed on blood sample at inclusion, first visit at 1 month and last visit at 6 months.', 'armGroupLabels': ['Patients with Thrombotic micro-angiopathy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'COUZI Lionel, MD', 'role': 'CONTACT'}, {'name': 'COUZI Lionel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'HARAMBAT Jérôme, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'DELMAS Muriel-Yahsou, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Cabestany', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'DECOURT Alexandre, MD', 'role': 'CONTACT'}, {'name': 'DECOURT Alexandre, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Site Médipôle Cabestany', 'geoPoint': {'lat': 42.68141, 'lon': 2.9409}}, {'city': 'Castelnau-le-Lez', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'JUGANT Sébastien, MD', 'role': 'CONTACT'}, {'name': 'JUGANT Sébastien, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Nephrocare Castelnau-le-Lez', 'geoPoint': {'lat': 43.63605, 'lon': 3.90137}}, {'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ROSTAING Lionel, MD', 'role': 'CONTACT'}, {'name': 'ROSTAING Lionel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'JOUVE Thomas, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'PROVOT François, MD', 'role': 'CONTACT'}, {'name': 'PROVOT François, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'NOVO Robert, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'MUGNIER Clovis, MD', 'role': 'CONTACT'}, {'name': 'MUGNIER Clovis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'GUIGONIS Vincent, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'DANTHU Clement, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'JOURDE-CHICHE Noémie, MD', 'role': 'CONTACT'}, {'name': 'JOURDE-CHICHE Noémie, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'SALLEE Marion, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'APHM-Hôpital de la Conception', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Moglie LE QUINTREC-DONNETTE, Pr', 'role': 'CONTACT'}], 'facility': 'Montpellier University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'VILLE Simon, MD', 'role': 'CONTACT'}, {'name': 'ROUSSEY Gwenaelle', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'VILLE Simon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Narbonne', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'COLDEFY Olivier, MD', 'role': 'CONTACT'}, {'name': 'COLDEFY Olivier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HPGN- Narbonne', 'geoPoint': {'lat': 43.18396, 'lon': 3.00141}}, {'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ESNAULT Vincent, MD', 'role': 'CONTACT'}, {'name': 'ESNAULT Vincent, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'SICARD Antoine, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'GOSSET Clément, MS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'MORANNE Olivier, MD', 'role': 'CONTACT'}, {'name': 'MORANNE Olivier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'MESNARD Laurent, MD', 'role': 'CONTACT'}, {'name': 'MESNARD Laurent, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'RAFAT Cédric, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'APHP-Hôpital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'SERVAIS Aude, MD', 'role': 'CONTACT'}, {'name': 'SERVAIS Aude, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'BOYER Olivia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'ZUBER Julien, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hôpital Paris Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Perpignan', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'CANET Sébastien, MD', 'role': 'CONTACT'}, {'name': 'CANET Sébastien, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH de Perpignan', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'BRIDOUX Frank, MD', 'role': 'CONTACT'}, {'name': 'BRIDOUX Frank, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'THIERRY Antoine, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'GUERROT Dominique, MD', 'role': 'CONTACT'}, {'name': 'GUERROT Dominique, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'GRANGE Steven, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'CAILLARD OHLMANN Sophie, MD', 'role': 'CONTACT'}, {'name': 'CAILLARD OHLMANN Sophie, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'RIBES David, MD', 'role': 'CONTACT'}, {'name': 'DECRAMER Stéphane, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'RIBES David, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'FAGUER Stanislas, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'HALIMI Jean-Michel, MD', 'role': 'CONTACT'}, {'name': 'HALIMI Jean-Michel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHRU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Moglie LE QUNITREC-DONNETTE, Professor', 'role': 'CONTACT', 'email': 'm-lequintrec-donnette@chu-montpellier.fr', 'phone': '467330996', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}