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Atypcial Hemolytic-Uremic Syndrome (aHUS) Registry

This study is currently recruiting participants.
Verified October 2017 by Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
First Posted: January 31, 2012
Last Update Posted: October 18, 2017
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.
INC Research
Information provided by (Responsible Party):
Alexion Pharmaceuticals
Post-marketing safety data on patients treated and untreated with eculizumab.

Atypical Hemolytic-Uremic Syndrome

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Other
Official Title: An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With aTypical Hemolytic-Uremic Syndrome (aHUS Registry)

Resource links provided by NLM:

Further study details as provided by Alexion Pharmaceuticals:

Primary Outcome Measures:
  • 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 in aHUS patients.

  • Time to first and subsequent occurrence of specified events. [ Time Frame: 10 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 treatment or other disease management approaches

Estimated Enrollment: 2000
Study Start Date: April 2012
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Detailed Description:
The study will capture post-marketing safety data on patients treated with eculizumab. Additionally, the study will collect information on the progression of disease in all patients.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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)

Inclusion Criteria:

  • Male or female patients of any age, including minors, who have been diagnosed with aHUS
  • 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
  Contacts and Locations
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

Contact: Project Manager ahus-registry@incresearch.com

United States, North Carolina
INC Research/InVentiv Health Recruiting
Wilmington, North Carolina, United States, 28405
Sponsors and Collaborators
Alexion Pharmaceuticals
INC Research
Study Director: Masayo Ogawa, MD, FAACP Alexion Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01522183     History of Changes
Other Study ID Numbers: M11-001
First Submitted: January 18, 2012
First Posted: January 31, 2012
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alexion Pharmaceuticals:
Atypical Hemolytic-Uremic Syndrome
Thrombotic Microangiopathy

Additional relevant MeSH terms:
Hemolytic-Uremic Syndrome
Atypical Hemolytic Uremic Syndrome
Pathologic Processes
Kidney Diseases
Urologic Diseases
Anemia, Hemolytic
Hematologic Diseases
Thrombotic Microangiopathies
Blood Platelet Disorders