Clinical trial NCT01522170: aHUS Observational Long Term Follow-Up
Official 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atypical Hemolytic Uremic Syndrome
Keywords: Atypical Hemolytic Uremic Syndrome
aHUS
Eculizumab
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-31
Enrollment: 94
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female aHUS, including minors, who previously participated in eculizumab clinical trials.

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.


Eligibility criteria: 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.

Exclusion Criteria:

* Not applicable.

Primary outcomes:
measure: TMA complication-free survival
timeFrame: 5 Years
Secondary outcomes:
measure: Duration of response, change over time of value for platelets, LDH, eGFR, Hgb, TMA intervention
timeFrame: 5 Years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Healthcare - Children's Center
state: Georgia
city: Dunwoody
country: United States
facility: Dunwoody Pediatrics & Children's Healthcare of Atlanta
state: Georgia
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Fort Wayne
country: United States
state: Indiana
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
city: Hawthorne
country: United States
facility: Hudson Valley Oncology Hematology
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Arthur James Cancer Hospital
state: Ohio
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center & Children's Hospital
state: Washington
city: Osh Kosh
country: United States
facility: Fox Valley Hematology
state: Wisconsin
city: North Tce. Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Graz
country: Austria
facility: Universitatsklinik fur Innere Medizin Medizinische Universitat Graz
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck
city: Gent
country: Belgium
facility: UZ Gent Dienst nefrologie
city: Liège
country: Belgium
facility: Chu Sart Tilman
city: Montreal
country: Canada
facility: Centre Hospitalier Universitaire (CHU) Sainte-Justine
city: Toronto
country: Canada
facility: The Hospital for Sick Children
city: Bordeaux Cedex
country: France
facility: Centre Hospitalier Universitaire Pellegrin, Service de Nephrologie Transplantation Dialyse
city: Caen
country: France
facility: CHRU de Caen
city: Le Kremlin Bicetre
country: France
facility: Le Kremlin Bicetre Hospital, Nephrology Unit
city: Lille
country: France
facility: CHRU de Lille-Hopital A.Calmette
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Marseille
country: France
facility: Hopital de la Timone Enfants, Unité de Néphrologie
city: Nantes
country: France
facility: CHU Hotel Dieu
city: Nice
country: France
facility: Le Centre Hospitalier Universitaire de Nice
city: Orleans
country: France
facility: Centre Hospitalier Regional de la Source, Service de nephrologie/hemodialyse
city: Paris
country: France
facility: Hopital Robert-Debré, Service de Néphrologie Pédiatrique
city: Paris
country: France
facility: Hopital Tenon
city: Quimper
country: France
facility: Centre Hospitalier Inter-Communal de Cornouaille
city: Rouen Cedex
country: France
facility: Hôpital de Bois Guillaume CHU de Rouen
city: Rouen
country: France
facility: CHU-CH Charles Nicolle Pavillon de Pédiatrie
city: Saint Priest En Jarez
country: France
facility: CHU de Saint-Etienne
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
city: Tours
country: France
facility: CHRU de Tours
city: Aachen
country: Germany
facility: Universitaetsklinikum Aachen Klinik fuer Nieren- und Hochdruckkrankheiten
city: Hannover
country: Germany
facility: Hannover University Clinic
city: Heidelberg
country: Germany
facility: Universitaet Heidelberg
city: Bergamo
country: Italy
facility: A.O. Papa Giovanni XXIII
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Genova
country: Italy
facility: Istituto Giannina Gaslini
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico Maggiore Policlinico
city: Palermo
country: Italy
facility: Ospedale dei Bambini G. di Cristina
city: Amsterdam
country: Netherlands
facility: AMC Medical Research B.V.
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre Nijmegen
city: Stockholm
country: Sweden
facility: Nephrology Clinic, Karolinska University Hospital
city: Bern
country: Switzerland
facility: INSELSPITAL Universitaetsklinik fuer Kinderheilkunde Kindernephrologie
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS
city: Nottingham
country: United Kingdom
facility: City Hospital, Nottingham University Hospitals, NHS Trust
Study officials:
References:
citation: 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.