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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
C11-003
Universal Trial Number (UTN)
Trial acronym
LTFU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atypical Hemolytic Uremic Syndrome 0 0
Condition category
Condition code
Blood 0 0 0 0
Other blood disorders
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Blood 0 0 0 0
Anaemia
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
TMA complication-free survival - Assess the long term efficacy of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study.
Timepoint [1] 0 0
5 Years
Secondary outcome [1] 0 0
Duration of response, change over time of value for platelets, LDH, eGFR, Hgb, TMA intervention - 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.
Timepoint [1] 0 0
5 Years

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.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Not applicable.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - North Tce. Adelaide
Recruitment postcode(s) [1] 0 0
- North Tce. Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
United States of America
State/province [9] 0 0
Wisconsin
Country [10] 0 0
Austria
State/province [10] 0 0
Graz
Country [11] 0 0
Austria
State/province [11] 0 0
Innsbruck
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Belgium
State/province [13] 0 0
Liège
Country [14] 0 0
Canada
State/province [14] 0 0
Montreal
Country [15] 0 0
Canada
State/province [15] 0 0
Toronto
Country [16] 0 0
France
State/province [16] 0 0
Bordeaux Cedex
Country [17] 0 0
France
State/province [17] 0 0
Caen
Country [18] 0 0
France
State/province [18] 0 0
Le Kremlin Bicetre
Country [19] 0 0
France
State/province [19] 0 0
Lille
Country [20] 0 0
France
State/province [20] 0 0
Lyon
Country [21] 0 0
France
State/province [21] 0 0
Marseille
Country [22] 0 0
France
State/province [22] 0 0
Nantes
Country [23] 0 0
France
State/province [23] 0 0
Nice
Country [24] 0 0
France
State/province [24] 0 0
Orleans
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
France
State/province [26] 0 0
Quimper
Country [27] 0 0
France
State/province [27] 0 0
Rouen Cedex
Country [28] 0 0
France
State/province [28] 0 0
Rouen
Country [29] 0 0
France
State/province [29] 0 0
Saint Priest En Jarez
Country [30] 0 0
France
State/province [30] 0 0
Strasbourg
Country [31] 0 0
France
State/province [31] 0 0
Tours
Country [32] 0 0
Germany
State/province [32] 0 0
Aachen
Country [33] 0 0
Germany
State/province [33] 0 0
Hannover
Country [34] 0 0
Germany
State/province [34] 0 0
Heidelberg
Country [35] 0 0
Italy
State/province [35] 0 0
Bergamo
Country [36] 0 0
Italy
State/province [36] 0 0
Firenze
Country [37] 0 0
Italy
State/province [37] 0 0
Genova
Country [38] 0 0
Italy
State/province [38] 0 0
Milano
Country [39] 0 0
Italy
State/province [39] 0 0
Palermo
Country [40] 0 0
Netherlands
State/province [40] 0 0
Amsterdam
Country [41] 0 0
Netherlands
State/province [41] 0 0
Nijmegen
Country [42] 0 0
Sweden
State/province [42] 0 0
Stockholm
Country [43] 0 0
Switzerland
State/province [43] 0 0
Bern
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Exeter
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Glasgow
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Newcastle upon Tyne
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alexion Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01522170
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01522170