Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01522183
Registration number
NCT01522183
Ethics application status
Date submitted
18/01/2012
Date registered
31/01/2012
Titles & IDs
Public title
Atypical Hemolytic-Uremic Syndrome (aHUS) Registry
Query!
Scientific title
An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With Atypical Hemolytic-Uremic Syndrome (aHUS Registry)
Query!
Secondary ID [1]
0
0
M11-001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Atypical Hemolytic-Uremic Syndrome
0
0
Query!
Condition category
Condition code
Blood
0
0
0
0
Query!
Other blood disorders
Query!
Renal and Urogenital
0
0
0
0
Query!
Kidney disease
Query!
Renal and Urogenital
0
0
0
0
Query!
Other renal and urogenital disorders
Query!
Blood
0
0
0
0
Query!
Anaemia
Query!
Other
0
0
0
0
Query!
Research that is not of generic health relevance and not applicable to specific health categories listed above
Query!
Intervention/exposure
Study type
Observational [Patient Registry]
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Proportion of patients who experience specified events
Query!
Assessment method [1]
0
0
To collect and evaluate safety and effectiveness data specific to the use of eculizumab or ravulizumab in aHUS patients.
Query!
Timepoint [1]
0
0
10 years
Query!
Primary outcome [2]
0
0
Time to first and subsequent occurrence of specified events.
Query!
Assessment method [2]
0
0
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
Query!
Timepoint [2]
0
0
5 years
Query!
Eligibility
Key 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.
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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]).
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
26/04/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/01/2031
Query!
Actual
Query!
Sample size
Target
3000
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Clinical Trial Site 1 - Westmead
Query!
Recruitment hospital [2]
0
0
Clinical Trial Site 2 - Westmead
Query!
Recruitment hospital [3]
0
0
Clinical Trial Site - Cairns
Query!
Recruitment hospital [4]
0
0
Clinical Trial Site - Herston
Query!
Recruitment hospital [5]
0
0
Clinical Trial Site - Woolloongabba
Query!
Recruitment hospital [6]
0
0
Clinical Trial Site - Adelaide
Query!
Recruitment hospital [7]
0
0
Clinical Trial Site - Heidelberg
Query!
Recruitment hospital [8]
0
0
Clinical Trial Site - Parkville
Query!
Recruitment hospital [9]
0
0
Clinical Trial Site - Murdoch
Query!
Recruitment hospital [10]
0
0
Clinical Trial Site - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [2]
0
0
4870 - Cairns
Query!
Recruitment postcode(s) [3]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [4]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [5]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [6]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [7]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [8]
0
0
3052 - Parkville
Query!
Recruitment postcode(s) [9]
0
0
6961 - Murdoch
Query!
Recruitment postcode(s) [10]
0
0
6109 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
District of Columbia
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Massachusetts
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Missouri
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
North Carolina
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Ohio
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Brussels
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Edegem
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Gent
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Leuven
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Liège
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Woluwe-Saint-Lambert
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Ontario
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Quebec
Query!
Country [17]
0
0
Denmark
Query!
State/province [17]
0
0
Odense
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Amiens
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Angers
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Bayonne
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Bordeaux
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Brest
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Bron
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Chambéry
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Clermont-Ferrand
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Dijon
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Grenoble
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Le Kremlin-Bicêtre
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Lille
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Lyon
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Marseille
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Montpellier
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Nancy
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Nantes
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Nice
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Paris
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Perpignan
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Poitiers
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Pontoise
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Rennes
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Rouen
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Strasbourg
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Toulouse
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Tours
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Valenciennes
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Essen
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Hannover
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Heidelberg
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Luebeck
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Münster
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Tübingen
Query!
Country [52]
0
0
Israel
Query!
State/province [52]
0
0
Be'er Sheva
Query!
Country [53]
0
0
Italy
Query!
State/province [53]
0
0
Bari
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Firenze
Query!
Country [55]
0
0
Italy
Query!
State/province [55]
0
0
Genova
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Milano
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Roma
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Torino
Query!
Country [59]
0
0
Korea, Republic of
Query!
State/province [59]
0
0
Chungcheongnam-do
Query!
Country [60]
0
0
Korea, Republic of
Query!
State/province [60]
0
0
Dongnam-ro
Query!
Country [61]
0
0
Korea, Republic of
Query!
State/province [61]
0
0
Gyeonggi-do
Query!
Country [62]
0
0
Korea, Republic of
Query!
State/province [62]
0
0
Hyeonchung-ro
Query!
Country [63]
0
0
Korea, Republic of
Query!
State/province [63]
0
0
Jebong Ro
Query!
Country [64]
0
0
Korea, Republic of
Query!
State/province [64]
0
0
Changwon
Query!
Country [65]
0
0
Korea, Republic of
Query!
State/province [65]
0
0
Seoul
Query!
Country [66]
0
0
Poland
Query!
State/province [66]
0
0
Lódz
Query!
Country [67]
0
0
Russian Federation
Query!
State/province [67]
0
0
Moscow
Query!
Country [68]
0
0
Russian Federation
Query!
State/province [68]
0
0
Saint Petersburg
Query!
Country [69]
0
0
Spain
Query!
State/province [69]
0
0
Barcelona
Query!
Country [70]
0
0
Spain
Query!
State/province [70]
0
0
Pamplona
Query!
Country [71]
0
0
Spain
Query!
State/province [71]
0
0
Sevilla
Query!
Country [72]
0
0
Taiwan
Query!
State/province [72]
0
0
Kaohsiung
Query!
Country [73]
0
0
Taiwan
Query!
State/province [73]
0
0
New Taipei City
Query!
Country [74]
0
0
Taiwan
Query!
State/province [74]
0
0
Taichung
Query!
Country [75]
0
0
Taiwan
Query!
State/province [75]
0
0
Taipei
Query!
Country [76]
0
0
United Kingdom
Query!
State/province [76]
0
0
Exeter
Query!
Country [77]
0
0
United Kingdom
Query!
State/province [77]
0
0
London
Query!
Country [78]
0
0
United Kingdom
Query!
State/province [78]
0
0
Manchester
Query!
Country [79]
0
0
United Kingdom
Query!
State/province [79]
0
0
Newcastle
Query!
Country [80]
0
0
United Kingdom
Query!
State/province [80]
0
0
Southampton
Query!
Country [81]
0
0
United Kingdom
Query!
State/province [81]
0
0
Wales
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Alexion Pharmaceuticals, Inc.
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Syneos Health
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01522183
Query!
Trial related presentations / 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. 2023 Apr;36(3):817-828. doi: 10.1007/s40620-022-01465-z. Epub 2022 Sep 24. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Nuria Saval
Query!
Address
0
0
Alexion Pharmaceuticals, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Alexion Pharmaceuticals, Inc. (Sponsor)
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-855-752-2356
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01522183