Atypical Hemolytic-Uremic SyndromeNCT01522183
Atypical Hemolytic-Uremic Syndrome (aHUS) Registry
An observational study of Atypical Hemolytic-Uremic Syndrome, run by Alexion Pharmaceuticals, Inc. at 141 sites in 17 countries.
Trial summary
Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atypical Hemolytic-Uremic Syndrome
- How many people
- 3,000 participants
- Where
- 141 sitesin 17 countries
- Study dates
- 18 Mar 2013to 1 Jan 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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]).
Trial locations and contacts
141 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
141 sites in 17 countries
France41 sites, 39 recruiting
- Recruiting
Clinical Trial Site 1
Amiens, 80054
Djeddi
- Recruiting
Clinical Trial Site 2
Amiens, 80054
Choukroun
- Recruiting
Clinical Trial Site
Angers, 49933
Augusto
- Recruiting
Clinical Trial Site
Bayonne, 64109
Lacraz
- Active, not recruiting
Clinical Trial Site
Bordeaux, 33076
- Recruiting
Clinical Trial Site
Brest, 29609
LeMeur
- Recruiting
Clinical Trial Site
Bron, 69677
Sellier-LeClerc
- Recruiting
Clinical Trial Site
Caen, 30001
Chatelet-Pouliquen
- Recruiting
Clinical Trial Site
Chambéry, 73011
Bally
- Recruiting
Clinical Trial Site
Clermont-Ferrand, 63000
Heng
- Recruiting
Clinical Trial Site
Dijon, 21080
Legendre
- Recruiting
Clinical Trial Site
Grenoble, 38043
Carron
- Recruiting
Clinical Trial Site
Le Kremlin-Bicêtre, 94270
Snanoudj
- Recruiting
Clinical Trial Site
Lille, 59037
Provot
- Withdrawn
Clinical Trial Site
Lille
- Recruiting
Clinical Trial Site
Lyon
Jolivot
- Recruiting
Clinical Trial Site
Marseille
Rousset-Rouviere
- Recruiting
Clinical Trial Site
Montpellier
Fila
- Recruiting
Clinical Trial Site 1
Nancy, 54500
Frimat
- Recruiting
Clinical Trial Site
Nancy, 54500
Vrillon
- Recruiting
Clinical Trial Site
Nantes, 44 093
Roussey
- Recruiting
Clinical Trial Site 1
Nantes, 44000
Ville
- Recruiting
Clinical Trial Site
Nice, 51069
Seitz-Polski
- Recruiting
Clinical Trial Site 2
Paris, 75015
Legendre
- Recruiting
Clinical Trial Site 4
Paris, 75015
Thervet
- Recruiting
Clinical Trial Site 1
Paris, 75019
Hogan
- Recruiting
Clinical Trial Site 5
Paris, 75743
Boyer
- Recruiting
Clinical Trial Site 3
Paris, 75970
Mesnard
- Recruiting
Clinical Trial Site
Perpignan
Vela
- Recruiting
Clinical Trial Site
Poitiers
Bridoux
- Recruiting
Clinical Trial Site
Pontoise
Devaud
- Recruiting
Clinical Trial Site
Rennes, 35203
Taque
- Recruiting
Clinical Trial Site
Rennes
Martins
- Recruiting
Clinical Trial Site 1
Rouen
Lebourg
- Recruiting
Clinical Trial Site 2
Rouen
Louillet
- Recruiting
Clinical Trial Site 1
Strasbourg
Moulin
- Recruiting
Clinical Trial Site 2
Strasbourg
Krummel
- Recruiting
Clinical Trial Site
Toulouse, 31059
Kamar
- Recruiting
Clinical Trial Site
Toulouse, 70034
Decramer
- Recruiting
Clinical Trial Site
Tours
Halimi
- Recruiting
Clinical Trial Site
Valenciennes, 50479
Ulrich
South Korea18 sites, 13 recruiting
- Active, not recruiting
Clinical Trial Site
Anyang-si, Gyeonggi-do, 14068
- Recruiting
Clinical Trial Site
Daegu, Hyeonchung-ro, 42415
Do
- Recruiting
Clinical Trial Site
Daegu, 35015
Kim
- Recruiting
Clinical Trial Site
Dongan, Chungcheongnam-do, 31151
Gil
- Withdrawn
Clinical Trial Site
Goyang-si, Gyeonggi-do, 411-706
- Recruiting
Clinical Trial Site
Gwangju, Jebong Ro, 61469
Bae
- Active, not recruiting
Clinical Trial Site 1
Gyeonggi-do, 13620
- Recruiting
Clinical Trial Site 2
Gyeonggi-do, 46371
Young Chong
- Active, not recruiting
Clinical Trial Site
Jeju-do, 63241
- Active, not recruiting
Clinical Trial Site
Jeollabuk-do, 54907
- Recruiting
Clinical Trial Site
Seoul, Dongnam-ro, 05278
Jung
- Recruiting
Clinical Trial Site 2
Seoul, 02841
Kim
- Recruiting
Clinical Trial Site 3
Seoul, 03722
Kim
- Recruiting
Clinical Trial Site 5
Seoul, 05505
Hoon Lee
- Recruiting
Clinical Trial Site 6
Seoul, 06351
Jang
- Recruiting
Clinical Trial Site 7
Seoul, 07985
Mun
- Recruiting
Clinical Trial Site 4
Seoul, 08308
Joo Kwon
- Recruiting
Clinical Trial Site 1
Seoul
Gyung Kang
Belgium12 sites, 11 recruiting
- Active, not recruiting
Clinical Trial Site
Brussels, 1020
- Recruiting
Clinical Trial Site
Brussels, 1070
Broeders
- Recruiting
Clinical Trial Site
Brussels, 1090
Pipeleers
- Recruiting
Clinical Trial Site (Adult)
Edegem, 2650
Massart
- Recruiting
Clinical Trial Site (Pediatric)
Edegem, 2650
Van Hoeck
- Recruiting
Clinical Trial Site (pediatric)
Ghent, 9000
Snauwaert
- Recruiting
Clinical Trial Site (Adult)
Leuven, 3000
Claes
- Recruiting
Clinical Trial Site (pediatric)
Leuven, 3000
Bockenhauer
- Recruiting
Clinical Trial Site (Adult)
Liège, 4000
Weekers
- Recruiting
Clinical Trial Site (pediatric)
Liège, 4000
Collard
- Recruiting
Clinical Trial Site (adult)
Woluwe-Saint-Lambert, 1200
Goffin
- Recruiting
Clinical Trial Site (Pediatric)
Woluwe-Saint-Lambert, 1200
Godefroid
Australia11 sites, 10 recruiting
- Recruiting
Clinical Trial Site
Adelaide, South Australia, 5000
Carroll
- Recruiting
Clinical Trial Site
Cairns, Queensland, 4870
Mantha
- Recruiting
Clinical Trial Site
Heidelberg, Victoria, 3084
Mount
- Recruiting
Clinical Trial Site
Herston, Queensland, 4029
Chandler
- Recruiting
Clinical Trial Site
Murdoch, Western Australia, 6961
Abraham
- Active, not recruiting
Clinical Trial Site
Nedlands, Western Australia, 6109
- Recruiting
Clinical Trial Site
Parkville, Victoria, 3050
Hughes
- Recruiting
Clinical Trial Site
Parkville, Victoria, 3052
Kausman
- Recruiting
Clinical Trial Site 1
Westmead, New South Wales, 2145
Durkan
- Recruiting
Clinical Trial Site 2
Westmead, New South Wales, 2145
Wong
- Recruiting
Clinical Trial Site
Woolloongabba, Queensland, 4102
Isbel
United States9 sites, 6 recruiting
- Recruiting
Clinical Trial Site
Atlanta, Georgia, 30322
Greenbaum
- Recruiting
Clinical Trial Site
Aurora, Colorado, 80045
Dixon
- Recruiting
Clinical Trial Site
Boston, Massachusetts, 02115
Alenizi
- Withdrawn
Clinical Trial Site
Chicago, Illinois, 60614
- Active, not recruiting
Clinical Trial Site
Columbus, Ohio, 43210
- Recruiting
Clinical Trial Site
Gainesville, Florida, 32610
Segal
- Recruiting
Clinical Trial Site
St Louis, Missouri, 63110
Majerus
- Recruiting
Clinical Trial Site
Washington D.C., District of Columbia, 20007
Broome
- Withdrawn
Clinical Trial Site
Winston-Salem, North Carolina, 27103
Italy9 sites, 8 recruiting
- Recruiting
Clinical Trial Site 1
Bari, 70124
Giordano
- Recruiting
Clinical Trial Site 2
Bari, 70124
Gesualdo
- Recruiting
Clinical Trial Site
Florence, 50134
Cirami
- Recruiting
Clinical Trial Site
Genova, 16147
Magnasco
- Recruiting
Clinical Trial Site 1
Milan, 20122
Ardissino
- Recruiting
Clinical Trial Site 2
Milan, 20122
Verdesca
- Recruiting
Clinical Trial Site
Milan, 20163
Ravera
- Recruiting
Clinical Trial Site
Roma, 00165
Vivarelli
- Withdrawn
Clinical Trial Site
Torino
United Kingdom9 sites, 8 recruiting
- Recruiting
Clinical Trial Site
Cardiff, C14 4XW
Griffin
- Recruiting
Clinical Trial Site
Exeter, EX2 5DW
Bingham
- Recruiting
Clinical Trial Site
London, NW3 2PF
Gale
- Recruiting
Clinical Trial Site
London, W1T 4EU
Scully
- Recruiting
Clinical Trial Site
London, WC1N 3JH
Marks
- Recruiting
Clinical Trial Site
Manchester, M13 9WL
Shenoy
- Withdrawn
Clinical Trial Site
Newcastle, NE7 7DN
- Recruiting
Clinical Trial Site
Southampton, SO16 6YD
Gilbert
- Recruiting
Clinical Trial Site
Wales, SA6 6NL
Mikhail
Germany7 sites, 5 recruiting
- Recruiting
Clinical Trial Site
Essen, 45147
Gackler
- Recruiting
Clinical Trial Site 1
Hanover, 30625
Schmidt-Ott
- Recruiting
Clinical Trial Site 2
Hanover, 30625
Kanzelmeyer
- Recruiting
Clinical Trial Site
Heidelberg, 69120
Wuehl
- Active, not recruiting
Clinical Trial Site
Lübeck, 23538
- Recruiting
Clinical Trial Site
Münster, 48149
Konrad
- Withdrawn
Clinical Trial Site
Tübingen, 72076
Canada4 sites, 4 recruiting
- Recruiting
Clinical Trial Site
London, Ontario, N6A 5W9
Huang
- Recruiting
Clinical Trial Site
Montreal, Quebec, H3T 1C5
Lapeyraque
- Recruiting
Clinical Trial Site
Québec, Quebec, 44035
Philibert
- Recruiting
Clinical Trial Site
Toronto, Ontario, M5G 1X8
Licht
Spain4 sites, 3 recruiting
- Recruiting
Clinical Trial Site 1
Barcelona, 09-08035
Ariceta
- Recruiting
Clinical Trial Site 2
Barcelona, 09-08035
Ramos
- Recruiting
Clinical Trial Site
Pamplona, 15-31008
Manrique
- Withdrawn
Clinical Trial Site
Seville, 01-41013
Taiwan4 sites, 4 recruiting
- Recruiting
Clinical Trial Site
Kaohsiung City, 81362
Chiou
- Recruiting
Clinical Trial Site
New Taipei City, 10002
Tsai
- Recruiting
Clinical Trial Site
Taichung, 40447
Huang
- Recruiting
Clinical Trial Site
Taoyuan, 33305
Tseng
Russia3 sites
- Completed
Clinical Trial Site 1
Moscow
- Completed
Clinical Trial Site 2
Moscow
- Completed
Clinical Trial Site
Saint Petersburg
Switzerland3 sites
- Terminated
Clinical Trial Site
Basel, 4031
- Terminated
Clinical Trial Site
Bern, 3010
- Terminated
Clinical Trial Site
Surich, 8091
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Clinical Trial Site
Ankara, 06500
Derici
- Recruiting
Clinical Trial Site
Istanbul, 34093
Yildiz
- Recruiting
Clinical Trial Site
Kayseri, 38039
Tokgoz
Poland2 sites, 2 recruiting
- Recruiting
Clinical Trial Site
Lodz, 92-213
Nowicki
- Recruiting
Clinical Trial Site
Lodz, 93-338
Pawlak-Bratkowska
Denmark1 site, 1 recruiting
- Recruiting
Clinical Trial Site
Odense, 5000
Dieperink
Israel1 site, 1 recruiting
- Recruiting
Clinical Trial Site
Beersheba, 84101
Schreiber
About this study
Official title: 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.
Read the 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.
- Conditions
- Atypical Hemolytic-Uremic Syndrome
- Keywords
- Atypical Hemolytic-Uremic Syndrome, aHUS, Thrombotic Microangiopathy, TMA
- Medical subject headings
- Atypical Hemolytic Uremic Syndrome, Thrombotic Microangiopathies
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who experience specified events
To collect and evaluate safety and effectiveness data specific to the use of eculizumab or ravulizumab in aHUS patients.
Measured: 10 years
Time to first and subsequent occurrence of specified events.
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study start18 Mar 2013
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atypical Hemolytic-Uremic SyndromeStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Nuria Saval, Study director, Alexion Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522183
- Sponsor's protocol ID
- M11-001
- Status last verified
- Sep 2025
- First submitted
- 18 Jan 2012
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 40875209Halimi 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.
PubMed 36152218Woodward 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.
PubMed 27871301Licht 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.
PubMed 26654630Belingheri 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.
PubMed 24843058Ardissino 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.
PubMed 24360866
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With Atypical Hemolytic-Uremic Syndrome (aHUS Registry)
- ClinicalTrials.gov ID
- NCT01522183
- Acronym / sponsor ID
- M11-001
- Conditions
- Atypical Hemolytic-Uremic Syndrome
- Keywords
- Atypical Hemolytic-Uremic Syndrome, aHUS, Thrombotic Microangiopathy, TMA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 18 Mar 2013 (actual)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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]).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients who experience specified events
Time frame: 10 years
To collect and evaluate safety and effectiveness data specific to the use of eculizumab or ravulizumab in aHUS patients.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Derived from this study: PubMed 40875209Gaeckler 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.
- Derived from this study: PubMed 36152218Halimi 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.
- Derived from this study: PubMed 27871301Woodward 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.
- Derived from this study: PubMed 26654630Licht 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.
- Derived from this study: PubMed 24843058Belingheri 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.
- Derived from this study: PubMed 24360866Ardissino 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.
- Individual participant dataSharing planned: No
Related trials for Atypical Hemolytic-Uremic Syndrome
Active, not recruitingObservational study
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
Atypical Hemolytic Uremic Syndrome(aHUS)
Active, not recruitingPhase 3
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Atypical Hemolytic Uremic Syndrome
RecruitingObservational study
Ravulizumab Outcomes in Polish Patients With aHUS
Atypical Hemolytic Uremic Syndrome
Active, not recruitingPhase 3
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Atypical Hemolytic Uremic Syndrome
RecruitingPhase 3
Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUS
Atypical Hemolytic Uremic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nuria Saval study director
Alexion Pharmaceuticals, Inc.
141 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atypical Hemolytic-Uremic Syndrome, run by Alexion Pharmaceuticals, Inc. at 141 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 141 sites in France, South Korea, Belgium, Australia, United States and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexion Pharmaceuticals, Inc. (Sponsor) (1-855-752-2356, clinicaltrials@alexion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who experience specified events (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01522183, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.