ClinicalTrials.gg
TerminatedNCT01522170LTFUUpdated Feb 24, 2017

aHUS Observational Long Term Follow-Up

An observational study in Atypical Hemolytic Uremic Syndrome, sponsored by Alexion Pharmaceuticals, Inc.. Terminated at 56 sites in 12 countries. Per ClinicalTrials.gov, last updated 2017-02-24.

Sponsored by Alexion Pharmaceuticals, Inc. (part of AstraZeneca) · Observational

Why this study was terminated
Remaining patients were offered a similar observational study (Alexion M11-001) to allow for robust, high quality data collection in a larger, single database

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
94
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 19 studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca — 4 open to participants now, 5 under way, none of them phase 3. Atypical Hemolytic Uremic Syndrome · AstraZeneca.

Started
2012
with 2 others
Observational
9 of 19
3 open now
Registered
7th of 19
by date

Among the 19 studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca, this one is one of 3 that started in 2012, is one of 9 observational ones, and was the 7th registered.

Atypical Hemolytic Uremic Syndrome

45 studies on the registry are indexed under Atypical Hemolytic Uremic Syndrome; 14 are open to participants now.

Browse Atypical Hemolytic Uremic Syndrome studies →

Open to participants now

4 of the 19 studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Who these studies take

Of the 12 Atypical Hemolytic Uremic Syndrome studies recruiting now, 10 (83%) set no upper age limit and none (0%) stop at 75 or younger; 6 take children under 18; 2 take healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 19 studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Atypical Hemolytic Uremic Syndrome

Keywords

  • Atypical Hemolytic Uremic Syndrome
  • aHUS
  • Eculizumab
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Male and female aHUS, including minors, who previously participated in eculizumab clinical trials.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 for their study information to be collected and retained in a database.

Exclusion criteria

Exclusion Criteria:

  • Not applicable.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
94 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

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.

    Time frame: 5 Years

Secondary outcomes

  1. 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.

    Time frame: 5 Years

07

Study locations

56 sites
  • 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
  • Fort Wayne, Indiana, United States
  • Boston Children's Hospital
    Boston, Massachusetts, United States
  • Henry Ford Health System
    Detroit, Michigan, United States
  • Children's Hospital at Montefiore
    Bronx, New York, United States
  • Hudson Valley Oncology Hematology
    Hawthorne, New York, United States
  • Weill Cornell Medical College
    New York, 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
    Osh Kosh, 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
    Gent, 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 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
  • Hôpital de Bois Guillaume CHU de Rouen
    Rouen Cedex, France
  • CHU-CH Charles Nicolle Pavillon de Pédiatrie
    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
    Hannover, Germany
  • Universitaet Heidelberg
    Heidelberg, Germany
  • 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, 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
08

References and documents

Publications

  • 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. PubMed 30971227 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2012 to primary completion in Jan 2017, 58 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 18, 2012
First posted
Jan 31, 2012
StartActual
Mar 2012
Primary completionActual
Jan 2017
CompletionActual
Jan 2017
Last update
Feb 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01522170
Responsible party
Sponsor
First posted
Jan 31, 2012
Start date
Mar 2012
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Feb 24, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion