Study Stopped
Remaining patients were offered a similar observational study (Alexion M11-001) to allow for robust, high quality data collection in a larger, single database
aHUS Observational Long Term Follow-Up
LTFU
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
1 other identifier
observational
94
11 countries
55
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2012
Longer than P75 for all trials
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2012
CompletedFirst Posted
Study publicly available on registry
January 31, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFebruary 24, 2017
February 1, 2017
4.8 years
January 18, 2012
February 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
TMA complication-free survival
Assess the long term efficacy of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study.
5 Years
Secondary Outcomes (1)
Duration of response, change over time of value for platelets, LDH, eGFR, Hgb, TMA intervention
5 Years
Eligibility Criteria
Male and female aHUS, including minors, who previously participated in eculizumab clinical trials.
You may qualify if:
- 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.
You may not qualify if:
- Not applicable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Emory Healthcare - Children's Center
Atlanta, Georgia, United States
Dunwoody Pediatrics & Children's Healthcare of Atlanta
Dunwoody, Georgia, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Unknown Facility
Fort Wayne, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Hudson Valley Oncology Hematology
Hawthorne, New York, United States
Weill Cornell Medical College
New York, New York, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Arthur James Cancer Hospital
Columbus, Ohio, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, United States
Fox Valley Hematology
Oshkosh, Wisconsin, United States
Royal Adelaide Hospital
North Tce. Adelaide, Australia
Universitatsklinik fur Innere Medizin Medizinische Universitat Graz
Graz, Austria
Medizinische Universitaet Innsbruck
Innsbruck, Austria
UZ Gent Dienst nefrologie
Ghent, Belgium
Chu Sart Tilman
Liège, Belgium
Centre Hospitalier Universitaire (CHU) Sainte-Justine
Montreal, Canada
The Hospital for Sick Children
Toronto, Canada
Centre Hospitalier Universitaire Pellegrin, Service de Nephrologie Transplantation Dialyse
Bordeaux, France
CHRU de Caen
Caen, France
Le Kremlin Bicetre Hospital, Nephrology Unit
Le Kremlin-Bicêtre, France
CHRU de Lille-Hopital A.Calmette
Lille, France
Hôpital Edouard Herriot
Lyon, France
Hopital de la Timone Enfants, Unité de Néphrologie
Marseille, France
CHU Hotel Dieu
Nantes, France
Le Centre Hospitalier Universitaire de Nice
Nice, France
Centre Hospitalier Regional de la Source, Service de nephrologie/hemodialyse
Orléans, France
Hopital Robert-Debré, Service de Néphrologie Pédiatrique
Paris, France
Hopital Tenon
Paris, France
Centre Hospitalier Inter-Communal de Cornouaille
Quimper, France
CHU-CH Charles Nicolle Pavillon de Pédiatrie
Rouen, France
Hôpital de Bois Guillaume CHU de Rouen
Rouen, France
CHU de Saint-Etienne
Saint-Priest-en-Jarez, France
Nouvel Hopital Civil
Strasbourg, France
CHRU de Tours
Tours, France
Universitaetsklinikum Aachen Klinik fuer Nieren- und Hochdruckkrankheiten
Aachen, Germany
Hannover University Clinic
Hanover, Germany
Universitaet Heidelberg
Heidelberg, Germany
A.O. Papa Giovanni XXIII
Bergamo, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
Istituto Giannina Gaslini
Genova, Italy
Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico Maggiore Policlinico
Milan, Italy
Ospedale dei Bambini G. di Cristina
Palermo, Italy
AMC Medical Research B.V.
Amsterdam, Netherlands
Radboud University Nijmegen Medical Centre Nijmegen
Nijmegen, Netherlands
Nephrology Clinic, Karolinska University Hospital
Stockholm, Sweden
INSELSPITAL Universitaetsklinik fuer Kinderheilkunde Kindernephrologie
Bern, Switzerland
Royal Devon & Exeter NHS Foundation Trust
Exeter, United Kingdom
Gartnavel General Hospital
Glasgow, United Kingdom
The Newcastle upon Tyne Hospitals NHS
Newcastle upon Tyne, United Kingdom
City Hospital, Nottingham University Hospitals, NHS Trust
Nottingham, United Kingdom
Related Publications (1)
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.
PMID: 30971227DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2012
First Posted
January 31, 2012
Study Start
March 1, 2012
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
February 24, 2017
Record last verified: 2017-02