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Source1

{
  "resourceType": "ResearchStudy",
  "id": "346485",
  "meta": {
    "versionId": "10",
    "lastUpdated": "2026-01-26T16:43:36.479Z",
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    ]
  },
  "language": "en",
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
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      "description": "Hospital/Clinic/Other health care facility"
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      "system": "https://euclinicaltrials.eu/clinicalTrialId",
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  "name": "CTIS_2024_516402_32_00_FHIR_Transform",
  "title": "Eculizumab in hypertensive emergency-associated hemolytic uremic syndrome: a randomized multicenter controlled trial (HYPERSHU)",
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      },
      "value": "Eculizumab in hypertensive emergency-associated hemolytic uremic syndrome: a randomized multicenter controlled trial (HYPERSHU)"
    },
    {
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      },
      "value": "Eculizumab dans le syndrome hémolytique et urémique associé à l'urgence hypertensive: essai contrôlé multicentrique randomisé (HYPERSHU)"
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      },
      "value": "Eculizumab dans le syndrome hémolytique et urémique associé à l'urgence hypertensive: essai contrôlé multicentrique randomisé (HYPERSHU)"
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  "status": "active",
  "phase": {
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        "code": "SEVCO:01035",
        "display": "phase 3 trial"
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      ],
      "text": "Adult patients with aHUS associated with HE and severe kidney involvement (needing dialysis or serum creatinine ≥ 354μM)",
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                "url": "content",
                "valueString": "Patients adultes présentant un SHUA associé à une HE et une atteinte rénale sévère (nécessitant une dialyse ou taux de créatinine sérique ≥  354µM)"
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    },
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          "display": "Atypical haemolytic uraemic syndrome"
        }
      ]
    }
  ],
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      "text": "Trial Category 2"
    },
    {
      "text": "Justification for trial category assignment: Phase III"
    },
    {
      "text": "Trial scope Therapy"
    },
    {
      "text": "Trial scope Safety"
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    {
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        "display": "Assistance Publique Hopitaux De Paris"
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        "text": "public contact"
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      "period": {
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            "code": "recruit",
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      "period": {
        "start": "2024-02-13"
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    }
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      "type": "Group",
      "identifier": {
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        },
        "system": "https://fevir.net/FLI",
        "value": "CTIS2024-516402-32-00 Eligibility Criteria",
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          "display": "Computable Publishing LLC"
        }
      },
      "display": "CTIS2024-516402-32-00 Eligibility Criteria"
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  },
  "objective": [
    {
      "name": "To demonstrate the efficacy of early Eculizumab administration added on standard of care BP control on dialysis-dependence at month 6 in HEaHUS patients with severely impaired initial renal function.",
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          {
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                "url": "lang",
                "valueCode": "fr"
              },
              {
                "url": "content",
                "valueString": "Démontrer l'efficacité de l'administration précoce d'Eculizumab, ajoutée au contrôle standard de la pression artérielle, sur la dépendance à la dialyse au troisième mois chez les patients atteints d’SHUa-HE dont la fonction rénale initiale est sévèrement altérée."
              }
            ],
            "url": "http://hl7.org/fhir/StructureDefinition/translation"
          }
        ]
      },
      "type": {
        "coding": [
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            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "primary",
            "display": "Primary"
          }
        ]
      }
    },
    {
      "name": "To evaluate the role of complement biomarkers in predicting therapeutic response",
      "_name": {
        "extension": [
          {
            "extension": [
              {
                "url": "lang",
                "valueCode": "fr"
              },
              {
                "url": "content",
                "valueString": "Évaluer le rôle des biomarqueurs du complément dans la prédiction de la réponse thérapeutique"
              }
            ],
            "url": "http://hl7.org/fhir/StructureDefinition/translation"
          }
        ]
      },
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "secondary",
            "display": "Secondary"
          }
        ]
      }
    },
    {
      "name": "To evaluate the frequency of complement genetic rare variants in this population",
      "_name": {
        "extension": [
          {
            "extension": [
              {
                "url": "lang",
                "valueCode": "fr"
              },
              {
                "url": "content",
                "valueString": "Évaluer la fréquence des variants génétiques rares du complément dans cette population"
              }
            ],
            "url": "http://hl7.org/fhir/StructureDefinition/translation"
          }
        ]
      },
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "secondary",
            "display": "Secondary"
          }
        ]
      }
    },
    {
      "name": "To evaluate the efficacy of early eculizumab administration added on standard of care BP control on 3-month (W13) and 12 months renal replacement therapy risk",
      "_name": {
        "extension": [
          {
            "extension": [
              {
                "url": "lang",
                "valueCode": "fr"
              },
              {
                "url": "content",
                "valueString": "Évaluer l'efficacité de l'administration précoce d'éculizumab, ajoutée au contrôle de la pression artérielle standard, sur le risque de traitement de suppléance rénale à 3 mois et 12 mois"
              }
            ],
            "url": "http://hl7.org/fhir/StructureDefinition/translation"
          }
        ]
      },
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "secondary",
            "display": "Secondary"
          }
        ]
      }
    },
    {
      "name": "To evaluate the frequency of severe infections in both groups",
      "_name": {
        "extension": [
          {
            "extension": [
              {
                "url": "lang",
                "valueCode": "fr"
              },
              {
                "url": "content",
                "valueString": "Évaluer la fréquence des infections graves dans les deux groupes"
              }
            ],
            "url": "http://hl7.org/fhir/StructureDefinition/translation"
          }
        ]
      },
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "secondary",
            "display": "Secondary"
          }
        ]
      }
    },
    {
      "name": "To evaluate the time to resolution of hemolysis and acute dialysis",
      "_name": {
        "extension": [
          {
            "extension": [
              {
                "url": "lang",
                "valueCode": "fr"
              },
              {
                "url": "content",
                "valueString": "Évaluer le temps de résolution de l'hémolyse et de la dialyse aiguë"
              }
            ],
            "url": "http://hl7.org/fhir/StructureDefinition/translation"
          }
        ]
      },
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "secondary",
            "display": "Secondary"
          }
        ]
      }
    },
    {
      "name": "To evaluate the frequency of histological lesions and their prognosis (if kidney biopsy is performed)",
      "_name": {
        "extension": [
          {
            "extension": [
              {
                "url": "lang",
                "valueCode": "fr"
              },
              {
                "url": "content",
                "valueString": "Évaluer la fréquence des lésions histologiques et leur pronostic (si une biopsie rénale est réalisée)"
              }
            ],
            "url": "http://hl7.org/fhir/StructureDefinition/translation"
          }
        ]
      },
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "secondary",
            "display": "Secondary"
          }
        ]
      }
    },
    {
      "name": "To evaluate the medico-economic impact of Eculizumab",
      "_name": {
        "extension": [
          {
            "extension": [
              {
                "url": "lang",
                "valueCode": "fr"
              },
              {
                "url": "content",
                "valueString": "Évaluer l'impact médico-économique de l'éculizumab"
              }
            ],
            "url": "http://hl7.org/fhir/StructureDefinition/translation"
          }
        ]
      },
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "secondary",
            "display": "Secondary"
          }
        ]
      }
    },
    {
      "name": "Objective of the first ancillary study: A first ancillary study will include a pangenomic analysis aimed at identifying new genetic variants associated with HE-aHUS. This ancillary study will be based on the residual genetic samples already scheduled in the biocollection. This ancillary study will be coordinated by Pr L. Mesnard (Nephrology Department, Tenon Hospital, Paris) and performed according to an already available funding",
      "_name": {
        "extension": [
          {
            "extension": [
              {
                "url": "lang",
                "valueCode": "fr"
              },
              {
                "url": "content",
                "valueString": "Objectif de la première étude ancillaire :\nUne première étude ancillaire comprendra une analyse pangénomique visant à identifier de nouveaux variants génétiques associés au HE-aHUS. Cette étude ancillaire sera basée sur les échantillons génétiques résiduels déjà prévus dans la biocollection. Cette étude ancillaire sera coordonnée par le Pr L. Mesnard (Service de Néphrologie, Hôpital Tenon, Paris) et réalisée selon un financement déjà disponible."
              }
            ],
            "url": "http://hl7.org/fhir/StructureDefinition/translation"
          }
        ]
      },
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "secondary",
            "display": "Secondary"
          }
        ]
      }
    },
    {
      "name": "Objective of any other potential ancillary study: biological collection For any other ancillary study: residual samples will be stored for a biological collection to identify new potential genetic and pathophysiological determinants of HE-aHUS (Department of Immunobiology, HEGP, Dr Frémeaux-Bacchi).",
      "_name": {
        "extension": [
          {
            "extension": [
              {
                "url": "lang",
                "valueCode": "fr"
              },
              {
                "url": "content",
                "valueString": "Objectif de toute(s) autre(s) étude(s) ancillaire(s) potentielle(s) : collection biologique \nIdentifier de nouveaux variants génétiques liés à l'HE-aHUS.\nPour toute autre étude ancillaire : les échantillons résiduels seront conservés pour une collection biologique afin d'identifier de nouveaux déterminants génétiques et physiopathologiques potentiels du HE-aHUS (Département d'Immunobiologie, HEGP, Dr Frémeaux-Bacchi)."
              }
            ],
            "url": "http://hl7.org/fhir/StructureDefinition/translation"
          }
        ]
      },
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "secondary",
            "display": "Secondary"
          }
        ]
      }
    },
    {
      "name": "Primary Endpoints",
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "primary",
            "display": "Primary"
          }
        ]
      },
      "outcomeMeasure": [
        {
          "name": "Response to therapy, defined by the absence of any of the following events: i) at 6-month follow-up: persistent renal replacement therapy, eGFR<15ml/mn/1,73m2, or patient death; ii) at W2 : persistent hemolysis despite well conducted antihypertensive therapy. Any Eculizumab rescue in the control group will be considered as a failure.",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "primary",
                "display": "Primary"
              }
            ]
          },
          "endpoint": {
            "reference": "EvidenceVariable/346487",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "CTIS2024-516402-32-00 Primary Outcome 1",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "CTIS2024-516402-32-00 Primary Outcome 1"
          }
        }
      ]
    },
    {
      "name": "Secondary Endpoints",
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "secondary",
            "display": "Secondary"
          }
        ]
      },
      "outcomeMeasure": [
        {
          "name": "Prognosis role of repeat complement biomarkers (W1, W4, W13)",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "secondary",
                "display": "Secondary"
              }
            ]
          },
          "endpoint": {
            "reference": "EvidenceVariable/346488",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "CTIS2024-516402-32-00 Secondary Outcome 1",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "CTIS2024-516402-32-00 Secondary Outcome 1"
          }
        },
        {
          "name": "Frequency of Complement genetic rare variants",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "secondary",
                "display": "Secondary"
              }
            ]
          },
          "endpoint": {
            "reference": "EvidenceVariable/346489",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "CTIS2024-516402-32-00 Secondary Outcome 2",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "CTIS2024-516402-32-00 Secondary Outcome 2"
          }
        },
        {
          "name": "Renal replacement therapy rates at months 3 and 12 follow-up",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "secondary",
                "display": "Secondary"
              }
            ]
          },
          "endpoint": {
            "reference": "EvidenceVariable/346490",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "CTIS2024-516402-32-00 Secondary Outcome 3",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "CTIS2024-516402-32-00 Secondary Outcome 3"
          }
        },
        {
          "name": "Frequency of severe infections (defined by the need for hospitalization)",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "secondary",
                "display": "Secondary"
              }
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