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New treatment option for Hypertensive Emergency-associated Hemolytic Uremic Syndrome
Official title Eculizumab in Hypertensive Emergency-associated Hemolytic Uremic Syndrome
ClinicalTrials.gov ID: NCT05726916
What this study is testing
What is Soliris®?
Soliris® is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hypertensive emergency-associated hemolytic uremic syndrome.
Also referred to as Eculizumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Hemolytic and uremic syndrome (HUS) is a clinic-biological syndrome related to thrombotic microangiopathy affecting predominantly the kidney. Atypical HUS (aHUS) has been historically defined as HUS occurring in the absence of infectious event.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 18years
- Hospitalization for HE-aHUS within prior 10 days:
- Presume acute renal failure (renal replacement therapy or serum creatinine ≥ 354µM)
- Mechanical hemolysis including: anemia, thrombopenia, and: low haptoglobin (\ 1,5UNL), or presence of schistocytes
- Severe hypertension with systolic blood pressure \>180mmHg or diastolic blood pressure\>110mmHg
You likely can't join if
- Atrophic kidneys with maximum length\<8cm on recent (\<1 month) renal ultrasound, CT scan, or renal MRI
- 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...
- High clinical suspicion of recent hemorrhagic or ischemic stroke.
- ADAMTS 13\<10%, HIV or HCV infection, positivity of 2 markers among: anticardiolipin IgG/antiBeta2 GP1 IgG/lupus anticoagulant, positivity of ANCA...
See the full eligibility criteria
- ≥ 18years
- Hospitalization for HE-aHUS within prior 10 days:
- Presume acute renal failure (renal replacement therapy or serum creatinine ≥ 354µM)
- Mechanical hemolysis including: anemia, thrombopenia, and: low haptoglobin (\ 1,5UNL), or presence of schistocytes
- Severe hypertension with systolic blood pressure \>180mmHg or diastolic blood pressure\>110mmHg
- Target organ damage, including neurological involvement (notably hypertensive encephalopathy, headache, confusion, nausea, posterior reversible encephalopathy syndrome), or cardiovascular involvement (notably acute left...
- 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.
- Atrophic kidneys with maximum length\<8cm on recent (\<1 month) renal ultrasound, CT scan, or renal MRI
- 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 hemorrhagic or ischemic stroke.
- 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
- people with unresolved Neisseria meningitidis infection
- people refusing Neisseria meningitidis vaccination or refusing antibioprophylaxis with oracillin (In case of penicillin allergy, antibioprophylaxis with macrolide couldbeproposed according to ANSM recommendations...
- 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.
- PCR SARS-CoV2 positive
- 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 treatment study involving human participants or being in the exclusion period at the end of a previous study involving human participants.
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.