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Eculizumab in hypertensive emergency-associated hemolytic uremic syndrome: a randomized multicenter controlled trial (HYPERSHU)
EU CTIS ID: 2024-516402-32-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Hospitalization forHE-aHUS within prior 10 days: o Presume acute renal failure (renal replacement therapy or serum creatinine ≥ 354μM). o Mechanical hemolysis including: anemia, and: thrombopenia, or low haptoglobin (1,5UNL), or presence of schistocytes or histological lesions of thrombotic microangiopathy 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)
- For women of childbearing potential: Effective contraception during the study and for at least 5 months after the last dose of treatment with eculizumab
- Subject affiliated to a social security regimen
- Subject having signed written informed consent
You likely can't join if
- Atrophic kidneys with maximum length<8cm on recent (<1 month) renal ultrasound, CT scan, or renal MRI
- Contra-indication to eculizumab or renin angiotensin system blockers
- Solid organ or haematopoietic transplant
- History (<1year) of active cancer or exposition to drugs associated with aHUS (< 3 months)
- Severe cognitive or psychiatric disorders, patients unable to give an informed consent
- Positive SARS-CoV2 PCR or antigenic test
See the full eligibility criteria
Who can join
- Age ≥ 18 years
- Hospitalization forHE-aHUS within prior 10 days: o Presume acute renal failure (renal replacement therapy or serum creatinine ≥ 354μM). o Mechanical hemolysis including: anemia, and: thrombopenia, or low haptoglobin (1,5UNL), or presence of schistocytes or histological lesions of thrombotic microangiopathy 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)
- For women of childbearing potential: Effective contraception during the study and for at least 5 months after the last dose of treatment with eculizumab
- Subject affiliated to a social security regimen
- Subject having signed written informed consent
What rules you out
- Atrophic kidneys with maximum length<8cm on recent (<1 month) renal ultrasound, CT scan, or renal MRI
- Contra-indication to eculizumab or renin angiotensin system blockers
- Solid organ or haematopoietic transplant
- History (<1year) of active cancer or exposition to drugs associated with aHUS (< 3 months)
- Severe cognitive or psychiatric disorders, patients unable to give an informed consent
- Positive SARS-CoV2 PCR or antigenic test
- Pregnant or breastfeeding woman or ineffective contraception
- Persons deprived of their liberty by judicial or administrative decision
- Persons under legal protection (guardianship, curatorship)
- Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants
- High clinical suspicion of Complement-mediated aHUS (including familial history of aHUS)
- High clinical suspicion of typical HUS (including Shiga Toxin-producing E. Coli infection) or Thrombotic thrombocytopenic purpura
- High clinical suspicion of secondary HUS related to autoimmune disease (including lupus, scleroderma, antiphospholipid syndrome, ANCA vasculitis), or C3 glomerulopathy.
- High clinical suspicion of recent constituted hemorrhagic or ischemic stroke justifying specific blood pressure targets
- 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)
- Active infection
- Subjects with unresolved Neisseria meningitidis infection
- 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))
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.