Atypical Hemolytic-Uremic Syndrome (aHUS) Registry
March 23, 2023 updated by: Alexion
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
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 (Anticipated)
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: Caroline Collupy
- Email: ahus-registry@syneoshealth.com
Study Locations
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New South Wales
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Westmead, New South Wales, Australia, 2145
- Recruiting
- Clinical Trial Site 1
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Contact:
- Durkan
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Westmead, New South Wales, Australia, 2145
- Recruiting
- Clinical Trial Site 2
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Contact:
- Chapman
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Queensland
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Cairns, Queensland, Australia, 4870
- Active, not recruiting
- Clinical Trial Site
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Herston, Queensland, Australia, 4029
- Active, not recruiting
- Clinical Trial Site
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Woolloongabba, Queensland, Australia, 4102
- Active, not recruiting
- Clinical Trial Site
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South Australia
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Adelaide, South Australia, Australia, 5000
- Active, not recruiting
- Clinical Trial Site
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Active, not recruiting
- Clinical Trial Site
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Parkville, Victoria, Australia, 3050
- Active, not recruiting
- Clinical Trial Site
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Parkville, Victoria, Australia, 3052
- Active, not recruiting
- Clinical Trial Site
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Western Australia
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Murdoch, Western Australia, Australia, 6961
- Active, not recruiting
- Clinical Trial Site
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Nedlands, Western Australia, Australia, 6109
- Active, not recruiting
- Clinical Trial Site
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Brussels, Belgium, 1020
- Recruiting
- Clinical Trial Site
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Contact:
- Adams
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Brussels, Belgium, 1070
- Recruiting
- Clinical Trial Site
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Contact:
- Broeders
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Brussels, Belgium, 1090
- Recruiting
- Clinical Trial Site
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Contact:
- Pipeleers
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Edegem, Belgium, 2650
- Recruiting
- Clinical Trial Site (adult)
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Contact:
- Massart
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Edegem, Belgium, 2650
- Recruiting
- Clinical Trial Site (Pediatric)
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Contact:
- Van Hoeck
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Gent, Belgium, 9000
- Recruiting
- Clinical Trial Site (Pediatric)
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Contact:
- Vande Walle
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Leuven, Belgium, 3000
- Recruiting
- Clinical Trial Site (adult)
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Contact:
- Claes
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Leuven, Belgium, 3000
- Recruiting
- Clinical Trial Site (Pediatric)
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Contact:
- Levtchenko
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Liège, Belgium, 4000
- Recruiting
- Clinical Trial Site (adult)
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Contact:
- Weekers
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Liège, Belgium, 4000
- Recruiting
- Clinical Trial Site (Pediatric)
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Contact:
- Collard
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Woluwe-Saint-Lambert, Belgium, 1200
- Recruiting
- Clinical Trial Site (adult)
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Contact:
- Goffin
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Woluwe-Saint-Lambert, Belgium, 1200
- Recruiting
- Clinical Trial Site (Pediatric)
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Contact:
- Godefroid
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Ontario
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London, Ontario, Canada, N6A 5W9
- Recruiting
- Clinical Trial Site
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Contact:
- Huang
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Toronto, Ontario, Canada, M5G 1X8
- Recruiting
- Clinical Trial Site
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Contact:
- Licht
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Quebec
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Montréal, Quebec, Canada, H3T 1C5
- Recruiting
- Clinical Trial Site
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Contact:
- Lapeyraque
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Québec, Quebec, Canada, 44035
- Recruiting
- Clinical Trial Site
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Contact:
- Philibert
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Odense, Denmark, 5000
- Recruiting
- Clinical Trial Site
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Contact:
- Dieperink
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Amiens, France, 80054
- Recruiting
- Clinical Trial Site
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Contact:
- Djeddi
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Angers, France, 49933
- Recruiting
- Clinical Trial Site
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Contact:
- Subra
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Bayonne, France, 64109
- Recruiting
- Clinical Trial Site
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Contact:
- Lacraz
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Bordeaux, France, 33076
- Recruiting
- Clinical Trial Site
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Contact:
- Delmas
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Brest, France, 29609
- Recruiting
- Clinical Trial Site
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Contact:
- LeMeur
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Bron, France, 69677
- Recruiting
- Clinical Trial Site
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Contact:
- Sellier-LeClerc
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Chambéry, France, 73011
- Recruiting
- Clinical Trial Site
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Contact:
- Bally
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Clermont-Ferrand, France, 63000
- Recruiting
- Clinical Trial Site
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Contact:
- Heng
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Dijon, France, 21079
- Recruiting
- Clinical Trial Site
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Contact:
- Mousson
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Grenoble, France, 38043
- Recruiting
- Clinical Trial Site
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Contact:
- Zaoui
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Le Kremlin-Bicêtre, France, 94270
- Recruiting
- Clinical Trial Site
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Contact:
- Durrbach
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Lille, France, 59037
- Recruiting
- Clinical Trial Site
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Contact:
- Provot
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Lille, France
- Withdrawn
- Clinical Trial Site
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Lyon, France
- Recruiting
- Clinical Trial Site
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Contact:
- Jolivot
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Marseille, France
- Recruiting
- Clinical Trial Site
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Contact:
- Rousset-Rouviere
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Montpellier, France
- Recruiting
- Clinical Trial Site
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Contact:
- Fila
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Nancy, France, 54511
- Recruiting
- Clinical Trial Site 1
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Contact:
- Frimat
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Nancy, France, 54511
- Recruiting
- Clinical Trial Site 2
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Contact:
- Vrillon
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Nantes, France, 44035
- Recruiting
- Clinical Trial Site 1
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Contact:
- Fakhouri
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Nantes, France, 44093
- Recruiting
- Clinical Trial Site 2
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Contact:
- Roussey
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Nice, France
- Recruiting
- Clinical Trial Site
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Contact:
- Seitz-Polski
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Paris, France, 75015
- Recruiting
- Clinical Trial Site 2
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Contact:
- Legendre
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Paris, France, 75015
- Recruiting
- Clinical Trial Site 4
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Contact:
- Thervet
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Paris, France, 75743
- Recruiting
- Clinical Trial Site 5
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Contact:
- Boyer
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Paris, France, 75935
- Recruiting
- Clinical Trial Site 1
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Contact:
- Deschenes
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Paris, France, 75970
- Recruiting
- Clinical Trial Site 3
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Contact:
- Rondeau
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Perpignan, France
- Recruiting
- Clinical Trial Site
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Contact:
- Vela
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Poitiers, France
- Recruiting
- Clinical Trial Site
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Contact:
- Bridoux
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Pontoise, France
- Recruiting
- Clinical Trial Site
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Contact:
- Devaud
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Rennes, France, 35203
- Recruiting
- Clinical Trial Site
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Contact:
- Choukroun
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Rennes, France
- Recruiting
- Clinical Trial Site
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Contact:
- Taque
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Rouen, France
- Recruiting
- Clinical Trial Site
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Contact:
- Louillet
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Strasbourg, France
- Recruiting
- Clinical Trial Site
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Contact:
- Hannedouche
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Toulouse, France
- Recruiting
- Clinical Trial Site
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Contact:
- Decramer
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Tours, France
- Recruiting
- Clinical Trial Site
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Contact:
- Halimi
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Valenciennes, France, 59322
- Recruiting
- Clinical Trial Site
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Contact:
- Haeck
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Essen, Germany, 45147
- Recruiting
- Clinical Trial Site
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Contact:
- Gackler
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Hannover, Germany, 30625
- Recruiting
- Clinical Trial Site 1
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Contact:
- Menne
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Hannover, Germany, 30625
- Recruiting
- Clinical Trial Site 2
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Contact:
- Pape
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Heidelberg, Germany, 69120
- Recruiting
- Clinical Trial Site
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Contact:
- Wuehl
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Luebeck, Germany, 23538
- Recruiting
- Clinical Trial Site
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Contact:
- Nitschke
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Münster, Germany, 48149
- Recruiting
- Clinical Trial Site
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Contact:
- Konrad
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Tübingen, Germany, 72076
- Recruiting
- Clinical Trial Site
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Contact:
- Guthoff
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Be'er Sheva, Israel, 84101
- Recruiting
- Clinical Trial Site
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Contact:
- Schreiber
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Bari, Italy, 70124
- Recruiting
- Clinical Trial Site 1
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Contact:
- Giordano
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Bari, Italy, 70124
- Recruiting
- Clinical Trial Site 2
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Contact:
- Gesualdo
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Firenze, Italy, 50134
- Recruiting
- Clinical Trial Site
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Contact:
- Cirami
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Genova, Italy, 50134
- Recruiting
- Clinical Trial Site
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Contact:
- Barbano
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Milano, Italy, 20122
- Recruiting
- Clinical Trial Site 1
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Contact:
- Ardissino
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Milano, Italy, 20122
- Active, not recruiting
- Clinical Trial Site 2
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Milano, Italy, 20163
- Recruiting
- Clinical Trial Site
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Contact:
- Ravera
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Roma, Italy, 00165
- Recruiting
- Clinical Trial Site
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Contact:
- Vivarelli
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Torino, Italy
- Withdrawn
- Clinical Trial Site
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Changwon, Korea, Republic of, 52828
- Recruiting
- Clinical Trial Site
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Contact:
- Kim
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Gyeonggi-do, Korea, Republic of
- Recruiting
- Clinical Trial Site 1
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Contact:
- Kim
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Gyeonggi-do, Korea, Republic of
- Recruiting
- Clinical Trial Site 2
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Contact:
- Oh
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Seoul, Korea, Republic of
- Recruiting
- Clinical Trial Site 1
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Contact:
- Cheong
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Seoul, Korea, Republic of
- Recruiting
- Clinical Trial Site 2
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Contact:
- Jo
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Seoul, Korea, Republic of
- Recruiting
- Clinical Trial Site 3
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Contact:
- Kim
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Seoul, Korea, Republic of
- Recruiting
- Clinical Trial Site 4
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Contact:
- Yoo
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Seoul, Korea, Republic of
- Recruiting
- Clinical Trial Site 5
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Contact:
- Park
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Seoul, Korea, Republic of
- Recruiting
- Clinical Trial Site 6
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Contact:
- Jang
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Seoul, Korea, Republic of
- Recruiting
- Clinical Trial Site 7
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Contact:
- Mun
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Chungcheongnam-do
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Dongan, Chungcheongnam-do, Korea, Republic of, 31538
- Recruiting
- Clinical Trial Site
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Dongnam-ro
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Seoul, Dongnam-ro, Korea, Republic of, 02447
- Recruiting
- Clinical Trial Site
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Gyeonggi-do
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Anyang-si, Gyeonggi-do, Korea, Republic of, 14068
- Recruiting
- Clinical Trial Site
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Goyang-si, Gyeonggi-do, Korea, Republic of, 411-706
- Recruiting
- Clinical Trial Site
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Hyeonchung-ro
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Daegu, Hyeonchung-ro, Korea, Republic of, 42415
- Recruiting
- Clinical Trial Site
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Jebong Ro
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Gwangju, Jebong Ro, Korea, Republic of, 61469
- Recruiting
- Clinical Trial Site
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Łódź, Poland, 92-213
- Recruiting
- Clinical Trial Site
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Contact:
- Nowicki
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Łódź, Poland, 93-338
- Recruiting
- Clinical Trial Site
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Contact:
- Jander
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Moscow, Russian Federation
- Completed
- Clinical Trial Site 1
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Moscow, Russian Federation
- Completed
- Clinical Trial Site 2
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Saint Petersburg, Russian Federation
- Completed
- Clinical Trial Site
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Barcelona, Spain, 09-08035
- Recruiting
- Clinical Trial Site
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Contact:
- Ariceta
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Pamplona, Spain, 15-31008
- Active, not recruiting
- Clinical Trial Site
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Sevilla, Spain, 01-41013
- Recruiting
- Clinical Trial Site
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Contact:
- Cabello
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Kaohsiung, Taiwan, 81362
- Recruiting
- Clinical Trial Site
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Contact:
- Chiou
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New Taipei City, Taiwan, 10002
- Active, not recruiting
- Clinical Trial Site
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Taichung, Taiwan, 40447
- Recruiting
- Clinical Trial Site
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Contact:
- Huang
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Taipei, Taiwan, 10002
- Recruiting
- Clinical Trial Site
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Contact:
- Tsai
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Exeter, United Kingdom, EX2 5DW
- Recruiting
- Clinical Trial Site
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Contact:
- Bingham
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London, United Kingdom, WC1N 3JH
- Recruiting
- Clinical Trial Site
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Contact:
- Rees
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London, United Kingdom, NW3 2PF
- Recruiting
- Clinical Trial Site
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Contact:
- Gale
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London, United Kingdom, W1T 4EU
- Recruiting
- Clinical Trial Site
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Contact:
- Scully
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Manchester, United Kingdom, M13 9WL
- Active, not recruiting
- Clinical Trial Site
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Newcastle, United Kingdom, NE7 7DN
- Recruiting
- Clinical Trial Site
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Contact:
- Johnson
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Southampton, United Kingdom, SO16 6YD
- Recruiting
- Clinical Trial Site
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Contact:
- Gilbert
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Wales, United Kingdom, SA6 6NL
- Recruiting
- Clinical Trial Site
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Contact:
- Mikhail
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Active, not recruiting
- Clinical Trial Site
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Florida
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Gainesville, Florida, United States, 32610
- Active, not recruiting
- Clinical Trial Site
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Georgia
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Atlanta, Georgia, United States, 30322
- Active, not recruiting
- Clinical Trial Site
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Illinois
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Chicago, Illinois, United States, 60614
- Active, not recruiting
- Clinical Trial Site
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Active, not recruiting
- Clinical Trial Site
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Missouri
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Saint Louis, Missouri, United States, 63110
- Active, not recruiting
- Clinical Trial Site
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North Carolina
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Winston-Salem, North Carolina, United States, 27103
- Active, not recruiting
- Clinical Trial Site
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Ohio
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Columbus, Ohio, United States, 43210
- Active, not recruiting
- Clinical Trial Site
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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
No
Genders Eligible for Study
All
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
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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
Collaborators
Investigators
- Study Director: Katerina Anokhina, MD, Alexion
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
- 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. 2022 Sep 24. doi: 10.1007/s40620-022-01465-z. Online ahead of print.
- 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.
- 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.
- 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.
- 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.
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)
April 30, 2012
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2025
Study Registration Dates
First Submitted
January 18, 2012
First Submitted That Met QC Criteria
January 27, 2012
First Posted (Estimate)
January 31, 2012
Study Record Updates
Last Update Posted (Actual)
March 27, 2023
Last Update Submitted That Met QC Criteria
March 23, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M11-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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AlexionCompletedAtypical Hemolytic Uremic Syndrome (aHUS)United States, France, Germany, Spain, Switzerland, Netherlands, Canada, Austria