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Atypcial Hemolytic-Uremic Syndrome (aHUS) Registry

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Alexion Pharmaceuticals
INC Research
Information provided by (Responsible Party):
Alexion Pharmaceuticals Identifier:
First received: January 18, 2012
Last updated: August 23, 2017
Last verified: August 2017
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01522183

Contact: Project Manager

United States, North Carolina
INC Research, Inc. via Locations in 22 Countries Globally Recruiting
Raleigh, North Carolina, United States
Sponsors and Collaborators
Alexion Pharmaceuticals
INC Research
Study Director: Masayo Ogawa, MD, FAACP Alexion Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alexion Pharmaceuticals Identifier: NCT01522183     History of Changes
Other Study ID Numbers: M11-001
Study First Received: January 18, 2012
Last Updated: August 23, 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 processed this record on September 21, 2017