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
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01522170
Registration number
NCT01522170
Ethics application status
Date submitted
18/01/2012
Date registered
31/01/2012
Date last updated
24/02/2017
Titles & IDs
Public title
aHUS Observational Long Term Follow-Up
Query!
Scientific title
An Observational, Multi-Center, Multi-National, Long Term Follow-Up Study of Atypical Hemolytic Uremic Syndrome (aHUS) Patients Treated With Eculizumab in a Prior Clinical Study
Query!
Secondary ID [1]
0
0
C11-003
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
LTFU
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
TMA complication-free survival
Query!
Assessment method [1]
0
0
Assess the long term efficacy of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study.
Query!
Timepoint [1]
0
0
5 Years
Query!
Secondary outcome [1]
0
0
Duration of response, change over time of value for platelets, LDH, eGFR, Hgb, TMA intervention
Query!
Assessment method [1]
0
0
Assess the long term safety of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study by collecting data on serious adverse events and targeted adverse events.
Query!
Timepoint [1]
0
0
5 Years
Query!
Eligibility
Key inclusion criteria
* aHUS patients who participated in any one of the aHUS-eculizumab clinical studies.
* aHUS patients or legal representative who are able and willing to given written informed consent for their study information to be collected and retained in a database.
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
* Not applicable.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/03/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/01/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
94
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Royal Adelaide Hospital - North Tce. Adelaide
Query!
Recruitment postcode(s) [1]
0
0
- North Tce. Adelaide
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Georgia
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Indiana
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Massachusetts
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Michigan
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New York
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Ohio
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Texas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Washington
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Wisconsin
Query!
Country [10]
0
0
Austria
Query!
State/province [10]
0
0
Graz
Query!
Country [11]
0
0
Austria
Query!
State/province [11]
0
0
Innsbruck
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Gent
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Liège
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Montreal
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Toronto
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Bordeaux Cedex
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Caen
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Le Kremlin Bicetre
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Lille
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Lyon
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Marseille
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Nantes
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Nice
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Orleans
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Paris
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Quimper
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Rouen Cedex
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Rouen
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Saint Priest En Jarez
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Strasbourg
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Tours
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Aachen
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Hannover
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Heidelberg
Query!
Country [35]
0
0
Italy
Query!
State/province [35]
0
0
Bergamo
Query!
Country [36]
0
0
Italy
Query!
State/province [36]
0
0
Firenze
Query!
Country [37]
0
0
Italy
Query!
State/province [37]
0
0
Genova
Query!
Country [38]
0
0
Italy
Query!
State/province [38]
0
0
Milano
Query!
Country [39]
0
0
Italy
Query!
State/province [39]
0
0
Palermo
Query!
Country [40]
0
0
Netherlands
Query!
State/province [40]
0
0
Amsterdam
Query!
Country [41]
0
0
Netherlands
Query!
State/province [41]
0
0
Nijmegen
Query!
Country [42]
0
0
Sweden
Query!
State/province [42]
0
0
Stockholm
Query!
Country [43]
0
0
Switzerland
Query!
State/province [43]
0
0
Bern
Query!
Country [44]
0
0
United Kingdom
Query!
State/province [44]
0
0
Exeter
Query!
Country [45]
0
0
United Kingdom
Query!
State/province [45]
0
0
Glasgow
Query!
Country [46]
0
0
United Kingdom
Query!
State/province [46]
0
0
Newcastle upon Tyne
Query!
Country [47]
0
0
United Kingdom
Query!
State/province [47]
0
0
Nottingham
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Alexion Pharmaceuticals, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
There is growing but limited information on the long term clinical status of aHUS patients who have previously received or are continuing to receive treatment with eculizumab. This study is designed to collect clinical data that will provide insight into the long-term outcomes of patients with aHUS.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01522170
Query!
Trial related presentations / publications
Menne J, Delmas Y, Fakhouri F, Licht C, Lommele A, Minetti EE, Provot F, Rondeau E, Sheerin NS, Wang J, Weekers LE, Greenbaum LA. Outcomes in patients with atypical hemolytic uremic syndrome treated with eculizumab in a long-term observational study. BMC Nephrol. 2019 Apr 10;20(1):125. doi: 10.1186/s12882-019-1314-1.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
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
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
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/NCT01522170
Download to PDF