Generated Narrative: Group 346486

Artifact Author: Brian S. Alper, MD, MSPH:

url: https://fevir.net/resources/Group/346486

identifier: FEvIR Object Identifier/https://fevir.net/FOI/346486, FEvIR Linking Identifier/CTIS2024-516402-32-00 Eligibility Criteria

name: CTIS2024_516402_32_00_Eligibility_Criteria

title: CTIS2024-516402-32-00 Eligibility Criteria

status: Active

publisher: Computable Publishing LLC

contact: support@computablepublishing.com

description:

copyright:

membership: Conceptual

combinationMethod: All of

characteristic

code: Eligibility Criterion

value: Age ≥ 18 years

exclude: false

characteristic

code: Eligibility Criterion

value: Hospitalization forHE-aHUS within prior 10 days: o Presume acute renal failure (renal replacement therapy or serum creatinine ≥ 354μM). o Mechanical hemolysis including: anemia, thrombopenia, and: low haptoglobin (1,5UNL), or presence of schistocytes o Severe hypertension with systolic blood pressure >180mmHg and/or diastolic blood pressure>110mmHg o Target organ damage, including neurological involvement (notably hypertensive encephalopathy, headache, confusion, nausea, posterior reversible encephalopathy syndrome), or cardiovascular involvement (notably acute left ventricular failure, acute pulmonary edema, acute cardiac ischemia, chest pain, dyspnea, palpitations), or ophtalmological involvement (notably ischemic retinopathy or blurred vision)

exclude: false

characteristic

code: Eligibility Criterion

value: For women of childbearing potential: Effective contraception during the study and for at least 5 months after the last dose of treatment with eculizumab

exclude: false

characteristic

code: Eligibility Criterion

value: Subject affiliated to a social security regimen

exclude: false

characteristic

code: Eligibility Criterion

value: Subject having signed written informed consent

exclude: false

characteristic

code: Eligibility Criterion

value: Atrophic kidneys with maximum length<8cm on recent (<1 month) renal ultrasound, CT scan, or renal MRI

exclude: true

characteristic

code: Eligibility Criterion

value: Contra-indication to eculizumab or renin angiotensin system blockers

exclude: true

characteristic

code: Eligibility Criterion

value: Solid organ or haematopoietic transplant

exclude: true

characteristic

code: Eligibility Criterion

value: History (<1year) of active cancer or exposition to drugs associated with aHUS (< 3 months)

exclude: true

characteristic

code: Eligibility Criterion

value: Severe cognitive or psychiatric disorders, patients unable to give an informed consent

exclude: true

characteristic

code: Eligibility Criterion

value: PCR SARS-CoV2 positive

exclude: true

characteristic

code: Eligibility Criterion

value: Pregnant or breastfeeding woman or ineffective contraception

exclude: true

characteristic

code: Eligibility Criterion

value: Persons deprived of their liberty by judicial or administrative decision

exclude: true

characteristic

code: Eligibility Criterion

value: Persons under legal protection (guardianship, curatorship)

exclude: true

characteristic

code: Eligibility Criterion

value: Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants

exclude: true

characteristic

code: Eligibility Criterion

value: High clinical suspicion of Complement-mediated aHUS (including familial history of aHUS)

exclude: true

characteristic

code: Eligibility Criterion

value: High clinical suspicion of typical HUS (including Shiga Toxin-producing E. Coli infection) or Thrombotic thrombocytopenic purpura

exclude: true

characteristic

code: Eligibility Criterion

value: High clinical suspicion of secondary HUS related to autoimmune disease (including lupus, scleroderma, antiphospholipid syndrome, ANCA vasculitis), or C3 glomerulopathy.

exclude: true

characteristic

code: Eligibility Criterion

value: High clinical suspicion of recent hemorrhagic or ischemic stroke

exclude: true

characteristic

code: Eligibility Criterion

value: ADAMTS 13<10%, HIV or HCV infection, positivity of 2 markers among: anticardiolipin IgG/antiBeta2 GP1 IgG/lupus anticoagulant, positivity of ANCA (ELISA PR3 or MPO)

exclude: true

characteristic

code: Eligibility Criterion

value: Active infection

exclude: true

characteristic

code: Eligibility Criterion

value: Subjects with unresolved Neisseria meningitidis infection

exclude: true

characteristic

code: Eligibility Criterion

value: Subjects refusing Neisseria meningitidis vaccination or refusing antibioprophylaxis with oracillin (In case of penicillin allergy, antibioprophylaxis with macrolide couldbeproposed according to ANSM recommendations (azithromycin or roxithromycin))

exclude: true