Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

NCT ID: NCT01522183

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-18

Study Completion Date

2031-01-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Atypical Hemolytic-Uremic Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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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 \[IRB/IEC\]).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Syneos Health

OTHER

Sponsor Role collaborator

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nuria Saval

Role: STUDY_DIRECTOR

Alexion Pharmaceuticals, Inc.

Locations

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Clinical Trial Site

Aurora, Colorado, United States

Site Status RECRUITING

Clinical Trial Site

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Clinical Trial Site

Gainesville, Florida, United States

Site Status RECRUITING

Clinical Trial Site

Atlanta, Georgia, United States

Site Status RECRUITING

Clinical Trial Site

Chicago, Illinois, United States

Site Status WITHDRAWN

Clinical Trial Site

Boston, Massachusetts, United States

Site Status RECRUITING

Clinical Trial Site

St Louis, Missouri, United States

Site Status RECRUITING

Clinical Trial Site

Winston-Salem, North Carolina, United States

Site Status WITHDRAWN

Clinical Trial Site

Columbus, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Clinical Trial Site 1

Westmead, New South Wales, Australia

Site Status RECRUITING

Clinical Trial Site 2

Westmead, New South Wales, Australia

Site Status RECRUITING

Clinical Trial Site

Cairns, Queensland, Australia

Site Status RECRUITING

Clinical Trial Site

Herston, Queensland, Australia

Site Status RECRUITING

Clinical Trial Site

Woolloongabba, Queensland, Australia

Site Status RECRUITING

Clinical Trial Site

Adelaide, South Australia, Australia

Site Status RECRUITING

Clinical Trial Site

Heidelberg, Victoria, Australia

Site Status RECRUITING

Clinical Trial Site

Parkville, Victoria, Australia

Site Status RECRUITING

Clinical Trial Site

Parkville, Victoria, Australia

Site Status RECRUITING

Clinical Trial Site

Murdoch, Western Australia, Australia

Site Status RECRUITING

Clinical Trial Site

Nedlands, Western Australia, Australia

Site Status ACTIVE_NOT_RECRUITING

Clinical Trial Site

Brussels, , Belgium

Site Status ACTIVE_NOT_RECRUITING

Clinical Trial Site

Brussels, , Belgium

Site Status RECRUITING

Clinical Trial Site

Brussels, , Belgium

Site Status RECRUITING

Clinical Trial Site (Adult)

Edegem, , Belgium

Site Status RECRUITING

Clinical Trial Site (Pediatric)

Edegem, , Belgium

Site Status RECRUITING

Clinical Trial Site (pediatric)

Ghent, , Belgium

Site Status RECRUITING

Clinical Trial Site (Adult)

Leuven, , Belgium

Site Status RECRUITING

Clinical Trial Site (pediatric)

Leuven, , Belgium

Site Status RECRUITING

Clinical Trial Site (Adult)

Liège, , Belgium

Site Status RECRUITING

Clinical Trial Site (pediatric)

Liège, , Belgium

Site Status RECRUITING

Clinical Trial Site (adult)

Woluwe-Saint-Lambert, , Belgium

Site Status RECRUITING

Clinical Trial Site (Pediatric)

Woluwe-Saint-Lambert, , Belgium

Site Status RECRUITING

Clinical Trial Site

London, Ontario, Canada

Site Status RECRUITING

Clinical Trial Site

Toronto, Ontario, Canada

Site Status RECRUITING

Clinical Trial Site

Montreal, Quebec, Canada

Site Status RECRUITING

Clinical Trial Site

Québec, Quebec, Canada

Site Status RECRUITING

Clinical Trial Site

Odense, , Denmark

Site Status RECRUITING

Clinical Trial Site 1

Amiens, , France

Site Status RECRUITING

Clinical Trial Site 2

Amiens, , France

Site Status RECRUITING

Clinical Trial Site

Angers, , France

Site Status RECRUITING

Clinical Trial Site

Bayonne, , France

Site Status RECRUITING

Clinical Trial Site

Bordeaux, , France

Site Status ACTIVE_NOT_RECRUITING

Clinical Trial Site

Brest, , France

Site Status RECRUITING

Clinical Trial Site

Bron, , France

Site Status RECRUITING

Clinical Trial Site

Caen, , France

Site Status RECRUITING

Clinical Trial Site

Chambéry, , France

Site Status RECRUITING

Clinical Trial Site

Clermont-Ferrand, , France

Site Status RECRUITING

Clinical Trial Site

Dijon, , France

Site Status RECRUITING

Clinical Trial Site

Grenoble, , France

Site Status RECRUITING

Clinical Trial Site

Le Kremlin-Bicêtre, , France

Site Status RECRUITING

Clinical Trial Site

Lille, , France

Site Status RECRUITING

Clinical Trial Site

Lille, , France

Site Status WITHDRAWN

Clinical Trial Site

Lyon, , France

Site Status RECRUITING

Clinical Trial Site

Marseille, , France

Site Status RECRUITING

Clinical Trial Site

Montpellier, , France

Site Status RECRUITING

Clinical Trial Site 1

Nancy, , France

Site Status RECRUITING

Clinical Trial Site

Nancy, , France

Site Status RECRUITING

Clinical Trial Site

Nantes, , France

Site Status RECRUITING

Clinical Trial Site 1

Nantes, , France

Site Status RECRUITING

Clinical Trial Site

Nice, , France

Site Status RECRUITING

Clinical Trial Site 2

Paris, , France

Site Status RECRUITING

Clinical Trial Site 4

Paris, , France

Site Status RECRUITING

Clinical Trial Site 1

Paris, , France

Site Status RECRUITING

Clinical Trial Site 5

Paris, , France

Site Status RECRUITING

Clinical Trial Site 3

Paris, , France

Site Status RECRUITING

Clinical Trial Site

Perpignan, , France

Site Status RECRUITING

Clinical Trial Site

Poitiers, , France

Site Status RECRUITING

Clinical Trial Site

Pontoise, , France

Site Status RECRUITING

Clinical Trial Site

Rennes, , France

Site Status RECRUITING

Clinical Trial Site

Rennes, , France

Site Status RECRUITING

Clinical Trial Site 1

Rouen, , France

Site Status RECRUITING

Clinical Trial Site 2

Rouen, , France

Site Status RECRUITING

Clinical Trial Site 1

Strasbourg, , France

Site Status RECRUITING

Clinical Trial Site 2

Strasbourg, , France

Site Status RECRUITING

Clinical Trial Site

Toulouse, , France

Site Status RECRUITING

Clinical Trial Site

Toulouse, , France

Site Status RECRUITING

Clinical Trial Site

Tours, , France

Site Status RECRUITING

Clinical Trial Site

Valenciennes, , France

Site Status RECRUITING

Clinical Trial Site

Essen, , Germany

Site Status RECRUITING

Clinical Trial Site 1

Hanover, , Germany

Site Status RECRUITING

Clinical Trial Site 2

Hanover, , Germany

Site Status RECRUITING

Clinical Trial Site

Heidelberg, , Germany

Site Status RECRUITING

Clinical Trial Site

Lübeck, , Germany

Site Status ACTIVE_NOT_RECRUITING

Clinical Trial Site

Münster, , Germany

Site Status RECRUITING

Clinical Trial Site

Tübingen, , Germany

Site Status WITHDRAWN

Clinical Trial Site

Beersheba, , Israel

Site Status RECRUITING

Clinical Trial Site 1

Bari, , Italy

Site Status RECRUITING

Clinical Trial Site 2

Bari, , Italy

Site Status RECRUITING

Clinical Trial Site

Florence, , Italy

Site Status RECRUITING

Clinical Trial Site

Genova, , Italy

Site Status RECRUITING

Clinical Trial Site 1

Milan, , Italy

Site Status RECRUITING

Clinical Trial Site 2

Milan, , Italy

Site Status RECRUITING

Clinical Trial Site

Milan, , Italy

Site Status RECRUITING

Clinical Trial Site

Roma, , Italy

Site Status RECRUITING

Clinical Trial Site

Torino, , Italy

Site Status WITHDRAWN

Clinical Trial Site

Lodz, , Poland

Site Status RECRUITING

Clinical Trial Site

Lodz, , Poland

Site Status RECRUITING

Clinical Trial Site 1

Moscow, , Russia

Site Status COMPLETED

Clinical Trial Site 2

Moscow, , Russia

Site Status COMPLETED

Clinical Trial Site

Saint Petersburg, , Russia

Site Status COMPLETED

Clinical Trial Site

Dongan, Chungcheongnam-do, South Korea

Site Status RECRUITING

Clinical Trial Site

Seoul, Dongnam-ro, South Korea

Site Status RECRUITING

Clinical Trial Site

Anyang-si, Gyeonggi-do, South Korea

Site Status ACTIVE_NOT_RECRUITING

Clinical Trial Site

Goyang-si, Gyeonggi-do, South Korea

Site Status WITHDRAWN

Clinical Trial Site

Daegu, Hyeonchung-ro, South Korea

Site Status RECRUITING

Clinical Trial Site

Gwangju, Jebong Ro, South Korea

Site Status RECRUITING

Clinical Trial Site

Daegu, , South Korea

Site Status RECRUITING

Clinical Trial Site 1

Gyeonggi-do, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Clinical Trial Site 2

Gyeonggi-do, , South Korea

Site Status RECRUITING

Clinical Trial Site

Jeju-do, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Clinical Trial Site

Jeollabuk-do, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Clinical Trial Site 2

Seoul, , South Korea

Site Status RECRUITING

Clinical Trial Site 3

Seoul, , South Korea

Site Status RECRUITING

Clinical Trial Site 5

Seoul, , South Korea

Site Status RECRUITING

Clinical Trial Site 6

Seoul, , South Korea

Site Status RECRUITING

Clinical Trial Site 7

Seoul, , South Korea

Site Status RECRUITING

Clinical Trial Site 4

Seoul, , South Korea

Site Status RECRUITING

Clinical Trial Site 1

Seoul, , South Korea

Site Status RECRUITING

Clinical Trial Site 1

Barcelona, , Spain

Site Status RECRUITING

Clinical Trial Site 2

Barcelona, , Spain

Site Status RECRUITING

Clinical Trial Site

Pamplona, , Spain

Site Status RECRUITING

Clinical Trial Site

Seville, , Spain

Site Status WITHDRAWN

Clinical Trial Site

Basel, , Switzerland

Site Status TERMINATED

Clinical Trial Site

Bern, , Switzerland

Site Status TERMINATED

Clinical Trial Site

Surich, , Switzerland

Site Status TERMINATED

Clinical Trial Site

Kaohsiung City, , Taiwan

Site Status RECRUITING

Clinical Trial Site

New Taipei City, , Taiwan

Site Status RECRUITING

Clinical Trial Site

Taichung, , Taiwan

Site Status RECRUITING

Clinical Trial Site

Taoyuan District, , Taiwan

Site Status RECRUITING

Clinical Trial Site

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Clinical Trial Site

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Clinical Trial Site

Kayseri, , Turkey (Türkiye)

Site Status RECRUITING

Clinical Trial Site

Cardiff, , United Kingdom

Site Status RECRUITING

Clinical Trial Site

Exeter, , United Kingdom

Site Status RECRUITING

Clinical Trial Site

London, , United Kingdom

Site Status RECRUITING

Clinical Trial Site

London, , United Kingdom

Site Status RECRUITING

Clinical Trial Site

London, , United Kingdom

Site Status RECRUITING

Clinical Trial Site

Manchester, , United Kingdom

Site Status RECRUITING

Clinical Trial Site

Newcastle, , United Kingdom

Site Status WITHDRAWN

Clinical Trial Site

Southampton, , United Kingdom

Site Status RECRUITING

Clinical Trial Site

Wales, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Belgium Canada Denmark France Germany Israel Italy Poland Russia South Korea Spain Switzerland Taiwan Turkey (Türkiye) United Kingdom

Central Contacts

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Alexion Pharmaceuticals, Inc. (Sponsor)

Role: CONTACT

1-855-752-2356

Facility Contacts

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Dixon

Role: primary

Broome

Role: primary

Segal

Role: primary

Greenbaum

Role: primary

Alenizi

Role: primary

Majerus

Role: primary

Durkan

Role: primary

Wong

Role: primary

Mantha

Role: primary

Chandler

Role: primary

Isbel

Role: primary

Carroll

Role: primary

Mount

Role: primary

Hughes

Role: primary

Kausman

Role: primary

Abraham

Role: primary

Broeders

Role: primary

Pipeleers

Role: primary

Massart

Role: primary

Van Hoeck

Role: primary

Snauwaert

Role: primary

Claes

Role: primary

Bockenhauer

Role: primary

Weekers

Role: primary

Collard

Role: primary

Goffin

Role: primary

Godefroid

Role: primary

Huang

Role: primary

Licht

Role: primary

Lapeyraque

Role: primary

Philibert

Role: primary

Dieperink

Role: primary

Djeddi

Role: primary

Choukroun

Role: primary

Augusto

Role: primary

Lacraz

Role: primary

LeMeur

Role: primary

Sellier-LeClerc

Role: primary

Chatelet-Pouliquen

Role: primary

Bally

Role: primary

Heng

Role: primary

Legendre

Role: primary

Carron

Role: primary

Snanoudj

Role: primary

Provot

Role: primary

Jolivot

Role: primary

Rousset-Rouviere

Role: primary

Fila

Role: primary

Frimat

Role: primary

Vrillon

Role: primary

Roussey

Role: primary

Ville

Role: primary

Seitz-Polski

Role: primary

Legendre

Role: primary

Thervet

Role: primary

Hogan

Role: primary

Boyer

Role: primary

Mesnard

Role: primary

Vela

Role: primary

Bridoux

Role: primary

Devaud

Role: primary

Taque

Role: primary

Martins

Role: primary

Lebourg

Role: primary

Louillet

Role: primary

Moulin

Role: primary

Krummel

Role: primary

Kamar

Role: primary

Decramer

Role: primary

Halimi

Role: primary

Ulrich

Role: primary

Gackler

Role: primary

Schmidt-Ott

Role: primary

Kanzelmeyer

Role: primary

Wuehl

Role: primary

Konrad

Role: primary

Schreiber

Role: primary

Giordano

Role: primary

Gesualdo

Role: primary

Cirami

Role: primary

Magnasco

Role: primary

Ardissino

Role: primary

Verdesca

Role: primary

Ravera

Role: primary

Vivarelli

Role: primary

Nowicki

Role: primary

Pawlak-Bratkowska

Role: primary

Gil

Role: primary

Jung

Role: primary

Do

Role: primary

Bae

Role: primary

Kim

Role: primary

Young Chong

Role: primary

Kim

Role: primary

Kim

Role: primary

Hoon Lee

Role: primary

Jang

Role: primary

Mun

Role: primary

Joo Kwon

Role: primary

Gyung Kang

Role: primary

Ariceta

Role: primary

Ramos

Role: primary

Manrique

Role: primary

Chiou

Role: primary

Tsai

Role: primary

Huang

Role: primary

Tseng

Role: primary

Derici

Role: primary

Yildiz

Role: primary

Tokgoz

Role: primary

Griffin

Role: primary

Bingham

Role: primary

Gale

Role: primary

Scully

Role: primary

Marks

Role: primary

Shenoy

Role: primary

Gilbert

Role: primary

Mikhail

Role: primary

References

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Gaeckler A, Al-Dakkak I, Saval N, Dieperink HH, Eygenraam M, Greenbaum LA, Isbel N, Walle JV. Effectiveness and Safety of Switching to Ravulizumab From Eculizumab in Kidney Transplant Recipients With Atypical Hemolytic Uremic Syndrome: A Global aHUS Registry Analysis. Clin Transplant. 2025 Sep;39(9):e70278. doi: 10.1111/ctr.70278.

Reference Type DERIVED
PMID: 40875209 (View on PubMed)

Halimi JM, Al-Dakkak I, Anokhina K, Ardissino G, Licht C, Lim WH, Massart A, Schaefer F, Walle JV, Rondeau E. Clinical characteristics and outcomes of a patient population with atypical hemolytic uremic syndrome and malignant hypertension: analysis from the Global aHUS registry. J Nephrol. 2023 Apr;36(3):817-828. doi: 10.1007/s40620-022-01465-z. Epub 2022 Sep 24.

Reference Type DERIVED
PMID: 36152218 (View on PubMed)

Woodward L, Johnson S, Walle JV, Beck J, Gasteyger C, Licht C, Ariceta G; aHUS Registry SAB. An innovative and collaborative partnership between patients with rare disease and industry-supported registries: the Global aHUS Registry. Orphanet J Rare Dis. 2016 Nov 21;11(1):154. doi: 10.1186/s13023-016-0537-5.

Reference Type DERIVED
PMID: 27871301 (View on PubMed)

Licht C, Ardissino G, Ariceta G, Cohen D, Cole JA, Gasteyger C, Greenbaum LA, Johnson S, Ogawa M, Schaefer F, Vande Walle J, Fremeaux-Bacchi V. The global aHUS registry: methodology and initial patient characteristics. BMC Nephrol. 2015 Dec 10;16:207. doi: 10.1186/s12882-015-0195-1.

Reference Type DERIVED
PMID: 26654630 (View on PubMed)

Belingheri M, Possenti I, Tel F, Paglialonga F, Testa S, Salardi S, Ardissino G. Cryptic activity of atypical hemolytic uremic syndrome and eculizumab treatment. Pediatrics. 2014 Jun;133(6):e1769-71. doi: 10.1542/peds.2013-2921. Epub 2014 May 19.

Reference Type DERIVED
PMID: 24843058 (View on PubMed)

Ardissino G, Possenti I, Tel F, Testa S, Paglialonga F. Time to change the definition of hemolytic uremic syndrome. Eur J Intern Med. 2014 Feb;25(2):e29. doi: 10.1016/j.ejim.2013.12.002. Epub 2013 Dec 21. No abstract available.

Reference Type DERIVED
PMID: 24360866 (View on PubMed)

Other Identifiers

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M11-001

Identifier Type: -

Identifier Source: org_study_id

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