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Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01522183
Recruitment Status : Recruiting
First Posted : January 31, 2012
Last Update Posted : March 16, 2022
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Brief Summary:
Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.

Condition or disease
Atypical Hemolytic-Uremic Syndrome

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With Atypical Hemolytic-Uremic Syndrome (aHUS Registry)
Actual Study Start Date : April 30, 2012
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025





Primary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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]).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522183


Contacts
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Contact: Caroline Collupy ahus-registry@syneoshealth.com

Locations
Hide Hide 131 study locations
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United States, District of Columbia
Georgetown University Hospital Active, not recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
University of Florida, Division of Nephrology Active, not recruiting
Gainesville, Florida, United States, 32610
United States, Georgia
Emory Children's Center Emory University Active, not recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Children's Memorial Hospital Active, not recruiting
Chicago, Illinois, United States, 60614
United States, Massachusetts
Brigham and Women's Hospital Active, not recruiting
Boston, Massachusetts, United States, 02115
United States, Missouri
Washington University School of Medicine Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Brookview Hills Research Associates LLC Active, not recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Arthur James Cancer Hospital Active, not recruiting
Columbus, Ohio, United States, 43210
Australia, New South Wales
Nepean Hospital Active, not recruiting
Penrith, New South Wales, Australia
The Children's Hospital at Westmead Active, not recruiting
Westmead, New South Wales, Australia
Westmead Hospital Active, not recruiting
Westmead, New South Wales, Australia
Australia, Queensland
Cairns Base Hospital Active, not recruiting
Cairns, Queensland, Australia
Royal Brisbane & Women's Hospital Active, not recruiting
Herston, Queensland, Australia
Princess Alexandra Hospital Active, not recruiting
Woolloongabba, Queensland, Australia
Australia, South Australia
Royal Adelaide Hospital Active, not recruiting
Adelaide, South Australia, Australia
Australia, Victoria
Austin Health Active, not recruiting
Heidelberg, Victoria, Australia
The Royal Children's Hospital Active, not recruiting
Parkville, Victoria, Australia
The Royal Melbourne Hospital Active, not recruiting
Parkville, Victoria, Australia
Australia, Western Australia
Fiona Stanley Hospital Active, not recruiting
Murdoch, Western Australia, Australia
Sir Charles Gairdner Hospital Active, not recruiting
Nedlands, Western Australia, Australia
Belgium
Hopital Erasme Recruiting
Brussels, Belgium
Contact: Broeders         
Hopital Universitaire des Enfants Reine Recruiting
Brussels, Belgium
Contact: Adams         
UZ Brussels Recruiting
Brussels, Belgium
Contact: Pipeleers         
UZA (Adult) Recruiting
Edegem, Belgium
Contact: Massart         
UZA (Pediatric) Recruiting
Edegem, Belgium
Contact: Van Hoeck         
UZ Gent (pediatric) Recruiting
Gent, Belgium
Contact: Vande Walle         
University Hospital Leuven (Adult) Recruiting
Leuven, Belgium
Contact: Claes         
University Hospital Leuven (pediatric) Recruiting
Leuven, Belgium
Contact: Levtchenko         
CHU de Liege - Clinique de l'Esperance (pediatric) Recruiting
Liège, Belgium
Contact: Collard         
CHU de Liege - Sart Tilman Recruiting
Liège, Belgium
Contact: Weekers         
Cliniques Universitaires Saint-Luc (adult) Recruiting
Woluwe-Saint-Lambert, Belgium
Contact: Goffin         
Cliniques Universitaires Saint-Luc (Pediatric) Recruiting
Woluwe-Saint-Lambert, Belgium
Contact: Godefroid         
Canada, Ontario
London Health Science Center Active, not recruiting
London, Ontario, Canada
The Hospital for Sick Children Active, not recruiting
Toronto, Ontario, Canada
Canada, Quebec
CHU Ste Justine Active, not recruiting
Montréal, Quebec, Canada
CHU de Quebec Hotel-Dieu de Quebec Active, not recruiting
Québec, Quebec, Canada
Denmark
Odense University Hospital Active, not recruiting
Odense, Denmark
France
CH Amiens - Hopital Nord Recruiting
Amiens, France
Contact: Djeddi         
Hopital Sud Recruiting
Amiens, France
Contact: Choukroun         
CHU Angers Recruiting
Angers, France
Contact: Subra         
CHG Bayonne Recruiting
Bayonne, France
Contact: Lacraz         
CHU de Bordeaux Pellegrin Recruiting
Bordeaux, France
Contact: Delmas         
CHRU Brest Recruiting
Brest, France
Contact: LeMeur         
Hopital Femme Mere Enfant Recruiting
Bron, France
Contact: Sellier-LeClerc         
CHRU de Caen Hopital Clemenceau Service de Nephrologie Recruiting
Caen, France
Contact: Chatalet-Pouliquen         
Centre Hospitialier Regional de Chambery Recruiting
Chambéry, France
Contact: Bally         
CHU Clermont Ferrand Recruiting
Clermont-Ferrand, France
Contact: Heng         
CHU Dijon Recruiting
Dijon, France
Contact: Mousson         
CHU Grenoble Recruiting
Grenoble, France
Contact: Zaoui         
Le Kremlin Bicetre Hospital Recruiting
Le Kremlin-Bicêtre, France
Contact: Durrbach         
CHRU de Lille Hopital A Calmette Recruiting
Lille, France
Contact: Provot         
CHRU de Lille Hopital Jeanne de Flandre Withdrawn
Lille, France
Hopital Edouard Herriot (CHU Lyon) Recruiting
Lyon, France
Contact: Jolivot         
Hopital de la Timone Enfants Recruiting
Marseille, France
Contact: Rousset-Rouviere         
CHU de Montpellier Recruiting
Montpellier, France
Contact: Fila         
Hopital Brabois Recruiting
Nancy, France
Contact: Frimat         
Hopital de Nancy Recruiting
Nancy, France
Contact: Vrillon         
CHU de Nantes-Hopital Hotel Dieu Recruiting
Nantes, France
Contact: Fakhouri         
Hopital Enfants et Adolescents Recruiting
Nantes, France
Contact: Roussey         
Le Centre Hospitialier Universitarie de Nice Hopital Pasteur Recruiting
Nice, France
Contact: Seitz-Polski         
HEGP - Hopital Europeen Georges Pompidou Recruiting
Paris, France
Contact: Thervet         
Hopital Necker, Enfants Malades Service de Nephrologie Pediatrique Recruiting
Paris, France
Contact: Boyer         
Hopital Necker Recruiting
Paris, France
Contact: Legendre         
Hopital Robert Debre Service de Nephrologie Pediatrique Recruiting
Paris, France
Contact: Deschenes         
Hopital Tenon Recruiting
Paris, France
Contact: Rondeau         
CH Perpignan Recruiting
Perpignan, France
Contact: Vela         
Hopital Poitiers Recruiting
Poitiers, France
Contact: Bridoux         
CHU de Pontoise Recruiting
Pontoise, France
Contact: Devaud         
CHU de Rennes Ponchaillou Recruiting
Rennes, France
Contact: Vigneau         
CHU Rennes, Hopital Sud Recruiting
Rennes, France
Contact: Taque         
CHU-CH Charles Nicolle Recruiting
Rouen, France
Contact: Louillet         
Hopital de Bois Guillaume CHU de Rouen Recruiting
Rouen, France
Contact: Lebourg         
Hopital Civil de Strasbourg Recruiting
Strasbourg, France
Contact: Hannedouche         
Nouvel Hopital Civil Recruiting
Strasbourg, France
Contact: Moulin         
CHU Rangueil Recruiting
Toulouse, France
Contact: Kamar         
Hopital des Enfants Recruiting
Toulouse, France
Contact: Decramer         
CHFU de Tours Recruiting
Tours, France
Contact: Halimi         
CH Valenciennes Recruiting
Valenciennes, France
Contact: Haeck         
Germany
Universitaetsklinikum Essen Active, not recruiting
Essen, Germany
Medizinische Hochschule Hannover Adult Nephrology Active, not recruiting
Hannover, Germany
Medizinische Hochschule Hannover Pediatric Nephrology Active, not recruiting
Hannover, Germany
Universitaet Heidelberg Active, not recruiting
Heidelberg, Germany
Universtaetskilinkum Schlkeswig-Holstein Active, not recruiting
Luebeck, Germany
Universitaetskilinikum Muenster Active, not recruiting
Münster, Germany
Universitaetsklinikum Tuebingen Active, not recruiting
Tübingen, Germany
Israel
Soroka University Medical Center Active, not recruiting
Be'er Sheva, Israel
Italy
Policlinico Consorziale de Bari Active, not recruiting
Bari, Italy
U O Nefrologia e Dialisi Pediatrica Ospedale Giovanni XXIII Active, not recruiting
Bari, Italy
Azienda Ospedaliero - Universitaria Careggi Active, not recruiting
Firenze, Italy
Istituto Giannina Gaslini Active, not recruiting
Genova, Italy
Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico Active, not recruiting
Milano, Italy
Pad Croff Nefrologia Ospedale Maggiore Policlinico Active, not recruiting
Milano, Italy
S C Nefrologia - A O Ospedale Niguarda-Ca Granda Active, not recruiting
Milano, Italy
Dipartmento di Nefrologia e Urologia Ospedale Pediatrico Bambin Gesu Active, not recruiting
Roma, Italy
Ospediale Pediatrico Regina Margherita Active, not recruiting
Torino, Italy
Korea, Republic of
Soon ChunHyang University Hospital Cheonan Recruiting
Dongan, Chungcheongnam-do, Korea, Republic of, 31538
Kyung Hee University Hospital at Gangdong Recruiting
Seoul, Dongnam-ro, Korea, Republic of, 02447
Hallym University Sacred Heart Hospital Recruiting
Anyang-si, Gyeonggi-do, Korea, Republic of, 14068
Inje University IlsanPaik Hospital Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 411-706
Yeungnam University Hospital Recruiting
Daegu, Hyeonchung-ro, Korea, Republic of, 42415
Chonnam National University Hospital Recruiting
Gwangju, Jebong Ro, Korea, Republic of, 61469
CHA Bundang Medical Center, CHA University Recruiting
Gyeonggi-do, Korea, Republic of
Contact: Oh         
The Catholic University of Korea, Uijeongnu St Mary's Hospital Recruiting
Gyeonggi-do, Korea, Republic of
Contact: Kim         
Pusan National University Yangsan Hospital Recruiting
Gyeongsang, Korea, Republic of
Contact: Kim         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Park         
Esha Womans University Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Mun         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jo         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yoo         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jang         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Cheong         
Severance Hospital Yonsei University Health System Recruiting
Seoul, Korea, Republic of
Contact: Kim         
Poland
NZOZ - TRI Medica Recruiting
Łódź, Poland
Contact: Jander         
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Klinkzny Recruiting
Łódź, Poland
Contact: Nowicki         
Russian Federation
Children's City Clinical Hospital of Saint Vladimir Completed
Moscow, Russian Federation
City Clinical Hospital #52 Completed
Moscow, Russian Federation
Saint Petersburg Medical University Completed
Saint Petersburg, Russian Federation
Spain
H. Valle Hebron Active, not recruiting
Barcelona, Spain
Complejo Hospitalario de Navarra Active, not recruiting
Pamplona, Spain
Hospital Virgen del Rocio Active, not recruiting
Sevilla, Spain
Taiwan
Veteran's General Hospital - Kaohsiung (VGH-KS) Active, not recruiting
Kaohsiung, Taiwan
Chang Cung Memorial Hospital - LK (CGMH-LK) Active, not recruiting
New Taipei City, Taiwan
China Medical University Hospital (CMUH) Active, not recruiting
Taichung, Taiwan
National Taiwan University Hospital (NTUH) Active, not recruiting
Taipei, Taiwan
United Kingdom
Royal Devon & Exeter NHS Foundation Trust Active, not recruiting
Exeter, United Kingdom
Great Ormond Street Hospital Active, not recruiting
London, United Kingdom
Royal Free Hospital Active, not recruiting
London, United Kingdom
University College London Hospitals NHS Foundation Trust Active, not recruiting
London, United Kingdom
Royal Manchester Children's Hospital Active, not recruiting
Manchester, United Kingdom
Newcastle Upon Tyne Hospitals NHS Foundation Trust Active, not recruiting
Newcastle, United Kingdom
Southampton General Hospital Active, not recruiting
Southampton, United Kingdom
Morriston Hospital Active, not recruiting
Wales, United Kingdom
Sponsors and Collaborators
Alexion Pharmaceuticals
Syneos Health
Investigators
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Study Director: Katerina Anokhina, MD Alexion Pharmaceuticals
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01522183    
Other Study ID Numbers: M11-001
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: March 16, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Alexion Pharmaceuticals:
Atypical Hemolytic-Uremic Syndrome
aHUS
Thrombotic Microangiopathy
TMA
Additional relevant MeSH terms:
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Azotemia
Hemolytic-Uremic Syndrome
Atypical Hemolytic Uremic Syndrome
Syndrome
Hemolysis
Disease
Pathologic Processes
Uremia
Kidney Diseases
Urologic Diseases
Anemia, Hemolytic
Anemia
Hematologic Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders