ClinicalTrials.gov record NCT05726916

Eculizumab in Hypertensive Emergency-associated Hemolytic Uremic Syndrome

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 25, 2026

Eculizumab in Hypertensive Emergency-associated Hemolytic Uremic Syndrome: a Randomized Multicenter Controlled Trial

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Jan 5, 2024, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 3A later-stage study, usually with more participants, designed to give stronger evidence about how well a treatment works and how safe it is. It often compares the treatment with standard care or a placebo, and results may support an application for approval.
Age18 years old and older
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 3 randomized, open-label trial compares early eculizumab plus tight blood-pressure control versus tight blood-pressure control alone in adults hospitalized with hypertensive emergency‑associated hemolytic uremic syndrome (HE‑aHUS) and severe acute kidney injury. The main measure is kidney function at 6 months; other outcomes are followed up to 12 months. The investigators plan to include 62 patients.

What it is studying. Whether adding early eculizumab to tight blood-pressure control changes kidney function, hemolysis control, and related outcomes in adults with HE‑aHUS and severe acute kidney injury.

What the researchers hope to learn. To determine the effect of early eculizumab on 6-month renal outcomes in HE‑aHUS. Secondary goals include measuring frequency of complement genetic rare variants, need for renal replacement therapy, rates of severe infection, time to hemolysis resolution, frequency of kidney lesions, and costs related to dialysis, eculizumab, other antihypertensive treatments, and hospitalizations up to 12 months.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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. The role of complement dysregulation in aHUS pathophysiology has been largely demonstrated, since C genetic rare variants are present in 60-70% aHUS patients. In line with the frequency of C dysregulation in aHUS, Eculizumab, an anti-C5 monoclonal antibody, has dramatically improved aHUS patients prognosis. Numerous conditions have been associated with aHUS, including hypertensive emergency (HE), a syndrome of acute blood pressure flare associated with end-organ damage. In cases of HE-aHUS, whether primary aHUS is complicated by secondary HE, or primary HE leads to secondary aHUS is still debated. The investigators recently demonstrated that C genetic variants frequency was similar in patients with HE-aHUS and patients with aHUS without HE, suggesting a major role for C dysregulation in HE-aHUS. Consequently, the investigators propose to evaluate, in HE-aHUS patients, the benefit of a strategy with early Eculizumab therapy (used within its marketing authorization and its conditions of refunding by the health insurance in usual care), compared to standard of care including tight blood pressure control. The hypothesis suggests that C dysregulation may impact renal prognosis of HE-aHUS patients. The investigator's aim to demonstrate that early Eculizumab therapy improves prognosis of HE-aHUS patients. Method The HYPERSHU study is a randomized, controlled, open-labelled study including HE-aHUS patients with severe AKI and no evidence of other conditions associated with HUS (infections, autoimmunity, drugs, pregnancy). The investigators plan to include 62 patients. Patients will be randomized in 2 arms:

  • Early Eculizumab therapy (for 3 months) added to standard of care (tight blood pressure control).
  • Standard of care alone with tight blood pressure control. Renal function after 6 months is the primary evaluation criterium.

HE is a frequently associated with aHUS, and strongly impacts patient renal prognosis. Efficient therapeutic strategies are still lacking for this condition. The HYPERSHU study will allow to evaluate the benefit of early Eculizumab therapy in patients with HE-aHUS and severe renal dysfunction.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Soliris®
  • Renin angiotensin system blockers

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If enrolled, participants are randomly assigned to either early intravenous eculizumab plus tight blood‑pressure control with renin–angiotensin system blockers, or to blood‑pressure control alone. People in the blood‑pressure‑control group can still be given eculizumab later as rescue treatment if they need it, though the study counts that as a treatment failure for its main 6‑month result. Eculizumab is given by IV infusion on a specified schedule (initial weekly doses then less frequent maintenance infusions). Participants will have regular clinic visits and blood tests to monitor kidney function and hemolysis markers, and follow‑up for the study primary endpoint at 6 months (with additional outcomes followed up to 12 months). Study rules require meningococcal vaccination and/or antibiotic prophylaxis and adherence to contraception timelines for those at risk of pregnancy.

How the study is structured. Randomized, open-label (no masking), parallel trial. Participants are assigned to either early eculizumab plus standard tight blood-pressure control or to tight blood-pressure control alone. Participants are treated and then followed for outcomes with the primary evaluation at 6 months and additional follow-up up to 12 months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on atypical hemolytic uremic syndrome

Clinical trials13 trials listed for atypical hemolytic uremic syndromeEvery trial the registry lists for atypical hemolytic uremic syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in atypical hemolytic uremic syndrome researchLatest monthly update: September 2026. Includes: Ravulizumab and labs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Nov 9, 2023
Primary completion
May 9, 2026 (estimated)
Study completion
Nov 9, 2027 (estimated)
Target enrollment
66 participants (estimated)
Last updated on registry
Jan 5, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Assistance Publique - Hôpitaux de Paris

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

usual care
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
CT scan
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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