Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

September 15, 2025 updated by: Alexion Pharmaceuticals, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Atypical Hemolytic-Uremic Syndrome

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Alexion Pharmaceuticals, Inc. (Sponsor)
Phone Number: 1-855-752-2356
Email: clinicaltrials@alexion.com

Study Locations

Australia
- New South Wales
  - Westmead, New South Wales, Australia, 2145
    - Recruiting
    - Clinical Trial Site 1
    - Contact:
      
      Durkan
  - Westmead, New South Wales, Australia, 2145
    - Recruiting
    - Clinical Trial Site 2
    - Contact:
      
      Wong
- Queensland
  - Cairns, Queensland, Australia, 4870
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Mantha
  - Herston, Queensland, Australia, 4029
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Chandler
  - Woolloongabba, Queensland, Australia, 4102
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Isbel
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Carroll
- Victoria
  - Heidelberg, Victoria, Australia, 3084
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Mount
  - Parkville, Victoria, Australia, 3050
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Hughes
  - Parkville, Victoria, Australia, 3052
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Kausman
- Western Australia
  - Murdoch, Western Australia, Australia, 6961
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Abraham
  - Nedlands, Western Australia, Australia, 6109
    - Active, not recruiting
    - Clinical Trial Site
Belgium
- - Brussels, Belgium, 1070
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Broeders
  - Brussels, Belgium, 1090
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Pipeleers
  - Brussels, Belgium, 1020
    - Active, not recruiting
    - Clinical Trial Site
  - Edegem, Belgium, 2650
    - Recruiting
    - Clinical Trial Site (adult)
    - Contact:
      
      Massart
  - Edegem, Belgium, 2650
    - Recruiting
    - Clinical Trial Site (Pediatric)
    - Contact:
      
      Van Hoeck
  - Ghent, Belgium, 9000
    - Recruiting
    - Clinical Trial Site (Pediatric)
    - Contact:
      
      Snauwaert
  - Leuven, Belgium, 3000
    - Recruiting
    - Clinical Trial Site (adult)
    - Contact:
      
      Claes
  - Leuven, Belgium, 3000
    - Recruiting
    - Clinical Trial Site (Pediatric)
    - Contact:
      
      Bockenhauer
  - Liège, Belgium, 4000
    - Recruiting
    - Clinical Trial Site (adult)
    - Contact:
      
      Weekers
  - Liège, Belgium, 4000
    - Recruiting
    - Clinical Trial Site (Pediatric)
    - Contact:
      
      Collard
  - Woluwe-Saint-Lambert, Belgium, 1200
    - Recruiting
    - Clinical Trial Site (adult)
    - Contact:
      
      Goffin
  - Woluwe-Saint-Lambert, Belgium, 1200
    - Recruiting
    - Clinical Trial Site (Pediatric)
    - Contact:
      
      Godefroid
Canada
- Ontario
  - London, Ontario, Canada, N6A 5W9
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Huang
  - Toronto, Ontario, Canada, M5G 1X8
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Licht
- Quebec
  - Montreal, Quebec, Canada, H3T 1C5
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Lapeyraque
  - Québec, Quebec, Canada, 44035
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Philibert
Denmark
- - Odense, Denmark, 5000
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Dieperink
France
- - Amiens, France, 80054
    - Recruiting
    - Clinical Trial Site 1
    - Contact:
      
      Djeddi
  - Amiens, France, 80054
    - Recruiting
    - Clinical Trial Site 2
    - Contact:
      
      Choukroun
  - Angers, France, 49933
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Augusto
  - Bayonne, France, 64109
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Lacraz
  - Bordeaux, France, 33076
    - Active, not recruiting
    - Clinical Trial Site
  - Brest, France, 29609
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      LeMeur
  - Bron, France, 69677
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Sellier-LeClerc
  - Caen, France, 30001
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Chatelet-Pouliquen
  - Chambéry, France, 73011
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Bally
  - Clermont-Ferrand, France, 63000
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Heng
  - Dijon, France, 21080
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Legendre
  - Grenoble, France, 38043
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Carron
  - Le Kremlin-Bicêtre, France, 94270
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Snanoudj
  - Lille, France, 59037
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Provot
  - Lille, France
    - Withdrawn
    - Clinical Trial Site
  - Lyon, France
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Jolivot
  - Marseille, France
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Rousset-Rouviere
  - Montpellier, France
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Fila
  - Nancy, France, 54500
    - Recruiting
    - Clinical Trial Site 1
    - Contact:
      
      Frimat
  - Nancy, France, 54500
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Vrillon
  - Nantes, France, 44 093
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Roussey
  - Nantes, France, 44000
    - Recruiting
    - Clinical Trial Site 1
    - Contact:
      
      Ville
  - Nice, France, 51069
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Seitz-Polski
  - Paris, France, 75015
    - Recruiting
    - Clinical Trial Site 2
    - Contact:
      
      Legendre
  - Paris, France, 75015
    - Recruiting
    - Clinical Trial Site 4
    - Contact:
      
      Thervet
  - Paris, France, 75743
    - Recruiting
    - Clinical Trial Site 5
    - Contact:
      
      Boyer
  - Paris, France, 75970
    - Recruiting
    - Clinical Trial Site 3
    - Contact:
      
      Mesnard
  - Paris, France, 75019
    - Recruiting
    - Clinical Trial Site 1
    - Contact:
      
      Hogan
  - Perpignan, France
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Vela
  - Poitiers, France
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Bridoux
  - Pontoise, France
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Devaud
  - Rennes, France, 35203
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Taque
  - Rennes, France
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Martins
  - Rouen, France
    - Recruiting
    - Clinical Trial Site 1
    - Contact:
      
      Lebourg
  - Rouen, France
    - Recruiting
    - Clinical Trial Site 2
    - Contact:
      
      Louillet
  - Strasbourg, France
    - Recruiting
    - Clinical Trial Site 1
    - Contact:
      
      Moulin
  - Strasbourg, France
    - Recruiting
    - Clinical Trial Site 2
    - Contact:
      
      Krummel
  - Toulouse, France, 31059
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Kamar
  - Toulouse, France, 70034
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Decramer
  - Tours, France
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Halimi
  - Valenciennes, France, 50479
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Ulrich
Germany
- - Essen, Germany, 45147
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Gackler
  - Hanover, Germany, 30625
    - Recruiting
    - Clinical Trial Site 1
    - Contact:
      
      Schmidt-Ott
  - Hanover, Germany, 30625
    - Recruiting
    - Clinical Trial Site 2
    - Contact:
      
      Kanzelmeyer
  - Heidelberg, Germany, 69120
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Wuehl
  - Lübeck, Germany, 23538
    - Active, not recruiting
    - Clinical Trial Site
  - Münster, Germany, 48149
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Konrad
  - Tübingen, Germany, 72076
    - Withdrawn
    - Clinical Trial Site
Israel
- - Beersheba, Israel, 84101
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Schreiber
Italy
- - Bari, Italy, 70124
    - Recruiting
    - Clinical Trial Site 1
    - Contact:
      
      Giordano
  - Bari, Italy, 70124
    - Recruiting
    - Clinical Trial Site 2
    - Contact:
      
      Gesualdo
  - Florence, Italy, 50134
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Cirami
  - Genova, Italy, 16147
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Magnasco
  - Milan, Italy, 20122
    - Recruiting
    - Clinical Trial Site 1
    - Contact:
      
      Ardissino
  - Milan, Italy, 20122
    - Recruiting
    - Clinical Trial Site 2
    - Contact:
      
      Verdesca
  - Milan, Italy, 20163
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Ravera
  - Roma, Italy, 00165
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Vivarelli
  - Torino, Italy
    - Withdrawn
    - Clinical Trial Site
Poland
- - Lodz, Poland, 92-213
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Nowicki
  - Lodz, Poland, 93-338
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Pawlak-Bratkowska
Russia
- - Moscow, Russia
    - Completed
    - Clinical Trial Site 1
  - Moscow, Russia
    - Completed
    - Clinical Trial Site 2
  - Saint Petersburg, Russia
    - Completed
    - Clinical Trial Site
South Korea
- - Daegu, South Korea, 35015
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Kim
  - Gyeonggi-do, South Korea, 13620
    - Active, not recruiting
    - Clinical Trial Site 1
  - Gyeonggi-do, South Korea, 46371
    - Recruiting
    - Clinical Trial Site 2
    - Contact:
      
      Young Chong
  - Jeju-do, South Korea, 63241
    - Active, not recruiting
    - Clinical Trial Site
  - Jeollabuk-do, South Korea, 54907
    - Active, not recruiting
    - Clinical Trial Site
  - Seoul, South Korea, 02841
    - Recruiting
    - Clinical Trial Site 2
    - Contact:
      
      Kim
  - Seoul, South Korea, 03722
    - Recruiting
    - Clinical Trial Site 3
    - Contact:
      
      Kim
  - Seoul, South Korea, 05505
    - Recruiting
    - Clinical Trial Site 5
    - Contact:
      
      Hoon Lee
  - Seoul, South Korea, 06351
    - Recruiting
    - Clinical Trial Site 6
    - Contact:
      
      Jang
  - Seoul, South Korea, 07985
    - Recruiting
    - Clinical Trial Site 7
    - Contact:
      
      Mun
  - Seoul, South Korea, 08308
    - Recruiting
    - Clinical Trial Site 4
    - Contact:
      
      Joo Kwon
  - Seoul, South Korea
    - Recruiting
    - Clinical Trial Site 1
    - Contact:
      
      Gyung Kang
- Chungcheongnam-do
  - Dongan, Chungcheongnam-do, South Korea, 31151
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Gil
- Dongnam-ro
  - Seoul, Dongnam-ro, South Korea, 05278
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Jung
- Gyeonggi-do
  - Anyang-si, Gyeonggi-do, South Korea, 14068
    - Active, not recruiting
    - Clinical Trial Site
  - Goyang-si, Gyeonggi-do, South Korea, 411-706
    - Withdrawn
    - Clinical Trial Site
- Hyeonchung-ro
  - Daegu, Hyeonchung-ro, South Korea, 42415
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Do
- Jebong Ro
  - Gwangju, Jebong Ro, South Korea, 61469
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Bae
Spain
- - Barcelona, Spain, 09-08035
    - Recruiting
    - Clinical Trial Site 1
    - Contact:
      
      Ariceta
  - Barcelona, Spain, 09-08035
    - Recruiting
    - Clinical Trial Site 2
    - Contact:
      
      Ramos
  - Pamplona, Spain, 15-31008
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Manrique
  - Seville, Spain, 01-41013
    - Withdrawn
    - Clinical Trial Site
Switzerland
- - Basel, Switzerland, 4031
    - Terminated
    - Clinical Trial Site
  - Bern, Switzerland, 3010
    - Terminated
    - Clinical Trial Site
  - Surich, Switzerland, 8091
    - Terminated
    - Clinical Trial Site
Taiwan
- - Kaohsiung City, Taiwan, 81362
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Chiou
  - New Taipei City, Taiwan, 10002
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Tsai
  - Taichung, Taiwan, 40447
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Huang
  - Taoyuan District, Taiwan, 33305
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Tseng
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06500
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Derici
  - Istanbul, Turkey (Türkiye), 34093
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Yildiz
  - Kayseri, Turkey (Türkiye), 38039
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Tokgoz
United Kingdom
- - Cardiff, United Kingdom, C14 4XW
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Griffin
  - Exeter, United Kingdom, EX2 5DW
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Bingham
  - London, United Kingdom, WC1N 3JH
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Marks
  - London, United Kingdom, NW3 2PF
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Gale
  - London, United Kingdom, W1T 4EU
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Scully
  - Manchester, United Kingdom, M13 9WL
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Shenoy
  - Newcastle, United Kingdom, NE7 7DN
    - Withdrawn
    - Clinical Trial Site
  - Southampton, United Kingdom, SO16 6YD
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Gilbert
  - Wales, United Kingdom, SA6 6NL
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Mikhail
United States
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Dixon
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20007
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Broome
- Florida
  - Gainesville, Florida, United States, 32610
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Segal
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Greenbaum
- Illinois
  - Chicago, Illinois, United States, 60614
    - Withdrawn
    - Clinical Trial Site
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Alenizi
- Missouri
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Clinical Trial Site
    - Contact:
      
      Majerus
- North Carolina
  - Winston-Salem, North Carolina, United States, 27103
    - Withdrawn
    - Clinical Trial Site
- Ohio
  - Columbus, Ohio, United States, 43210
    - Active, not recruiting
    - Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Male or female patients of any age, including minors, who have been diagnosed with aHUS; clinical diagnosis of aHUS, patients with or without an identified complement regulatory factor genetic abnormality or anti-complement factor antibody, ADAMTS13 > 5% (if performed)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who experience specified events Time Frame: 10 years	To collect and evaluate safety and effectiveness data specific to the use of eculizumab or ravulizumab in aHUS patients.	10 years
Time to first and subsequent occurrence of specified events. Time Frame: 5 years	To assess the long term manifestations of thrombotic microangiopathy (TMA) complications of aHUS as well as other clinical outcomes, including morbidity and mortality in aHUS patients, receiving eculizumab or ravulizumab treatment or other disease management approaches	5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion Pharmaceuticals, Inc.

Collaborators

Syneos Health

Investigators

Study Director: Nuria Saval, Alexion Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2013

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

January 27, 2012

First Posted (Estimated)

January 31, 2012

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M11-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Detailed Description

Study Type

Enrollment (Estimated)

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Clinical Trials on Atypical Hemolytic-Uremic Syndrome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations