Who may be eligible for the Atypical Hemolytic-Uremic Syndrome (aHUS) Registry trial?

Inclusion Criteria: * Male or female patients of any age, including minors, who have been diagnosed with aHUS * Patients with or without an identified complement pathogenic variant or anti-complement factor antibody * Able to give written informed consent. Patient or patient's parent/legal guardian must be willing and able to given written informed consent and the patient (if minor) must be willing to give written informed assent \[if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees (IRB/IEC)\]. * ADAMTS13 \> 5%, if performed. Exclusion Criteria: * Hemolytic Uremic Syndrome (HUS) only due to Shiga Toxin producing Escherichia coli (STEC). * Unable to give written informed consent. Patient or patient's parent/legal guardian unable to give written informed consent. Patient (if minor) unable to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees \[IRB/IEC\]).

ClinicalTrials.gov record NCT01522183

Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With Atypical Hemolytic-Uremic Syndrome (aHUS Registry)

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

SexAll

LocationAustralia, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Poland, Russia, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States

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 is an observational registry of people diagnosed with atypical hemolytic-uremic syndrome (aHUS). It collects post-marketing safety information on patients treated or untreated with eculizumab or ravulizumab and records disease progression. Participants are followed over time with a target duration of 5 years for routine data collection.

What it is studying. The study is collecting and evaluating post-marketing safety and effectiveness data specific to the use of eculizumab or ravulizumab in people with aHUS, and it aims to characterize long-term thrombotic microangiopathy (TMA) complications, disease progression, morbidity, and mortality.

What the researchers hope to learn. To collect and evaluate post-marketing safety and effectiveness data for eculizumab and ravulizumab in aHUS; to describe the progression of aHUS and long-term TMA complications; and to assess clinical outcomes including morbidity and mortality.

What this study is about

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

Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.

Eligibility

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

Inclusion criteria

Male or female patients of any age, including minors, who have been diagnosed with aHUS
Patients with or without an identified complement pathogenic variant or anti-complement factor antibody
Able to give written informed consent. Patient or patient's parent/legal guardian must be willing and able to given written informed consent and the patient (if minor) must be willing to give written informed assent [if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees (IRB/IEC)].
ADAMTS13 > 5%, if performed.

Exclusion criteria

Hemolytic Uremic Syndrome (HUS) only due to Shiga Toxin producing Escherichia coli (STEC).
Unable to give written informed consent. Patient or patient's parent/legal guardian unable to give written informed consent. Patient (if minor) unable to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees [IRB/IEC]).

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

The study will capture post-marketing safety data on patients treated with eculizumab or ravulizumab. Additionally, the study will collect information on the progression of disease in all patients.

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.

This is an observational registry (no study treatment assigned). If you join, study staff will collect your medical and treatment history, record safety events (including for those treated with eculizumab or ravulizumab), and track disease progression and clinical outcomes. Data collection and follow-up are planned for up to about 5 years. Joining requires written informed consent (and assent for minors when required).

How the study is structured. An observational, non-interventional, multi-center, multi-national registry. The study records information from patients' medical care without assigning treatments. Target follow-up for participants is 5 years; certain safety and outcome events are tracked according to the registry's outcome timelines (registry lists some events up to 10 years).

Questions you could ask

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

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The listed sites are in Australia, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Poland, Russia, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States. 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: Mar 18, 2013
Primary completion: Jan 1, 2031 (estimated)
Study completion: Jan 1, 2031 (estimated)
Target enrollment: 3000 participants (estimated)
Last updated on registry: Sep 16, 2025
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: Alexion Pharmaceuticals, Inc.
Collaborators: Syneos Health

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Alexion Pharmaceuticals, Inc. (Sponsor) 📞 1-855-752-2356 ✉ clinicaltrials@alexion.com

Participating sites (141)

Filter by country:

Clinical Trial SiteRecruiting
Aurora, Colorado, 80045 · United States
- Dixon
Clinical Trial SiteRecruiting
Washington D.C., District of Columbia, 20007 · United States
- Broome
Clinical Trial SiteRecruiting
Gainesville, Florida, 32610 · United States
- Segal
Clinical Trial SiteRecruiting
Atlanta, Georgia, 30322 · United States
- Greenbaum
Clinical Trial SiteWithdrawn
Chicago, Illinois, 60614 · United States
Clinical Trial SiteRecruiting
Boston, Massachusetts, 02115 · United States
- Alenizi
Clinical Trial SiteRecruiting
St Louis, Missouri, 63110 · United States
- Majerus
Clinical Trial SiteWithdrawn
Winston-Salem, North Carolina, 27103 · United States
Clinical Trial SiteActive Not Recruiting
Columbus, Ohio, 43210 · United States
Clinical Trial Site 1Recruiting
Westmead, New South Wales, 2145 · Australia
- Durkan

Terms used on this page · explanations by MedicalUpdates.ai

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.
legal guardian: A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
assent: A child's or dependent adult's agreement to take part, given alongside the formal consent of a parent or legal representative.
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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