Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01522170
Other study ID # C11-003
Secondary ID
Status Terminated
Phase N/A
First received January 18, 2012
Last updated February 22, 2017
Start date March 2012
Est. completion date January 2017

Study information

Verified date February 2017
Source Alexion Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 94
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Australia Royal Adelaide Hospital North Tce. Adelaide
Austria Universitatsklinik fur Innere Medizin Medizinische Universitat Graz Graz
Austria Medizinische Universitaet Innsbruck Innsbruck
Belgium UZ Gent Dienst nefrologie Gent
Belgium Chu Sart Tilman Liège
Canada Centre Hospitalier Universitaire (CHU) Sainte-Justine Montreal
Canada The Hospital for Sick Children Toronto
France Centre Hospitalier Universitaire Pellegrin, Service de Nephrologie Transplantation Dialyse Bordeaux Cedex
France CHRU de Caen Caen
France Le Kremlin Bicetre Hospital, Nephrology Unit Le Kremlin Bicetre
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 Orleans
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 Cedex
France CHU de Saint-Etienne Saint Priest En Jarez
France Nouvel Hopital Civil Strasbourg
France CHRU de Tours Tours
Germany Universitaetsklinikum Aachen Klinik fuer Nieren- und Hochdruckkrankheiten Aachen
Germany Hannover University Clinic Hannover
Germany Universitaet Heidelberg Heidelberg
Italy A.O. Papa Giovanni XXIII Bergamo
Italy Azienda Ospedaliero-Universitaria Careggi Firenze
Italy Istituto Giannina Gaslini Genova
Italy Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico Maggiore Policlinico Milano
Italy Ospedale dei Bambini G. di Cristina Palermo
Netherlands AMC Medical Research B.V. Amsterdam
Netherlands Radboud University Nijmegen Medical Centre Nijmegen Nijmegen
Sweden Nephrology Clinic, Karolinska University Hospital Stockholm
Switzerland INSELSPITAL Universitaetsklinik fuer Kinderheilkunde Kindernephrologie Bern
United Kingdom 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 States Emory Healthcare - Children's Center Atlanta Georgia
United States Boston Children's Hospital Boston Massachusetts
United States Children's Hospital at Montefiore 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 Henry Ford Health System Detroit Michigan
United States Dunwoody Pediatrics & Children's Healthcare of Atlanta Dunwoody Georgia
United States Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
United States Hudson Valley Oncology Hematology Hawthorne New York
United States The Methodist Hospital Research Institute Houston Texas
United States Weill Cornell Medical College New York New York
United States Fox Valley Hematology Osh Kosh Wisconsin
United States Seattle Children's Hospital Seattle Washington
United States Providence Sacred Heart Medical Center & Children's Hospital Spokane Washington

Sponsors (1)

Lead Sponsor Collaborator
Alexion Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 5 Years
See also
  Status Clinical Trial Phase
Recruiting NCT03605511 - TTP and aHUS in Complicated Pregnancies
Withdrawn NCT03303313 - A Study of an Investigational Drug, Cemdisiran (ALN-CC5), in Patients With Atypical Hemolytic Uremic Syndrome Phase 2
Recruiting NCT04861259 - A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Phase 3
Recruiting NCT06065852 - National Registry of Rare Kidney Diseases
Terminated NCT02614898 - Evaluation of Potential Predictors of Disease Progression in Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Including Genetics, Biomarkers, and Treatment
Completed NCT02574403 - Study Assessing an Algorithm-based Strategy of Eculizumab Discontinuation in Children and Adults With aHUS Phase 4
Recruiting NCT04958265 - A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Phase 3
Recruiting NCT05795140 - Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUS Phase 3
Completed NCT00844545 - Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant aHUS Phase 2
Completed NCT00844844 - Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant aHUS Phase 2
Terminated NCT02464891 - Complement Inhibition in aHUS Dialysis Patients Phase 2
Withdrawn NCT02626663 - The Role of Microparticles as a Biomarker
Recruiting NCT01793168 - Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Completed NCT00844428 - Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive aHUS Phase 2
Completed NCT00838513 - Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-sensitive Atypical Hemolytic Uremic Syndrome (aHUS) Phase 2
Withdrawn NCT03999840 - Eculizumab to Cemdisiran Switch in aHUS Phase 2
Recruiting NCT04889430 - Efficacy and Safety of Iptacopan (LNP023) in Adult Patients With Atypical Hemolytic Uremic Syndrome Naive to Complement Inhibitor Therapy Phase 3
Recruiting NCT05935215 - Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Phase 3
Recruiting NCT03205995 - Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome Phase 3
Recruiting NCT05996731 - Developing a Pipeline to Employ RNA-Seq as a Complementary Diagnostic Tool in Rare Diseases N/A