Eculizumab for treating hemolytic uremic syndrome linked to hypertensive emergencies
Official title: Eculizumab in Hypertensive Emergency-associated Hemolytic Uremic Syndrome: a Randomized Multicenter Controlled Trial
Run by Assistance Publique - Hôpitaux de Paris · NCT05726916 · Data updated 2026-11-12
This study is testing if Eculizumab can help people with kidney problems caused by severe high blood pressure feel better and recover faster.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 66 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | eculizumab |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | November 9, 2023 |
| Main results expected | May 9, 2026 |
| Study ends | November 9, 2027 |
| Registry record updated | January 5, 2024 |
| Trial ID | NCT05726916 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have been hospitalized for HE-aHUS within the last 10 days and meet specific clinical criteria.
✕Probably not a fit
Patients who do not have hypertensive emergency-associated hemolytic uremic syndrome or those with other underlying conditions that preclude participation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of Eculizumab, an anti-C5 monoclonal antibody, in patients suffering from hypertensive emergency-associated hemolytic uremic syndrome (HE-aHUS). The study aims to determine the efficacy of Eculizumab in improving outcomes for patients who have experienced acute renal failure and severe hypertension. Participants must be hospitalized for HE-aHUS and exhibit specific clinical criteria, including signs of hemolysis and target organ damage. The trial will assess the impact of Eculizumab on renal function and overall patient prognosis.
Why it matters
Potential benefit: If successful, this treatment could significantly improve kidney function and overall health outcomes for patients with HE-aHUS.
How similar studies have gone: Previous studies have shown promising results with Eculizumab in treating atypical hemolytic uremic syndrome, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion 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 (\<LNL), or elevated LDH (\>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 ventricular failure, acute pulmonary edema, acute cardiac ischemia, chest pain, dyspnea, palpitations), or ophtalmological involvement (notably ischemic retinopathy or blurred vision) * 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. Exclusion Criteria: * 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 * 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)). * 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 interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants.
Where it's running
-
Tenon Hospital
Paris, France Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.