Evaluation of Potential Predictors of Disease Progression in Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Including Genetics, Biomarkers, and Treatment

Stopped early

Conditions studied: Atypical Hemolytic Uremic Syndrome

In brief

This was a prospective, open-label study with no participant randomization. Treatment for aHUS was observational and at the discretion of the treating physician. The purpose of this study was to assess disease manifestations of complement-mediated thrombotic microangiopathy (TMA) and evaluate potential clinical predictors of disease manifestations and progression in participants with aHUS with or without eculizumab treatment in the clinical setting.

Key facts

Study ID

NCT02614898

Run by

Alexion Pharmaceuticals, Inc.

People needed

67

Starts

2015-11-04

Expected to finish

2017-10-05

Last updated by the study team

2020-01-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Currently receiving eculizumab treatment in the M11-001 aHUS Registry
• Two normal platelet counts at least 4 weeks apart
• Two normal lactate dehydrogenase levels at least 4 weeks apart
• Willing, committed, and able to return for all clinic visits and complete all study-related procedures
• Participant or participant's parent/legal guardian must have been willing and able to give written informed consent. Participant (if minor) must have been willing to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees)

You may not qualify if…

• Any prior eculizumab treatment discontinuation
• On chronic dialysis (defined as ≥3 months on dialysis)
• Currently participating in another complement inhibitor trial
• Life expectancy of <6 months
• Participant or participant's parent/legal guardian was unable to give written informed consent. Participant (if minor) was unable to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees)

Where it is running

• Clinical Trial Site — Washington D.C., District of Columbia, United States
• Clinical Trial Site — Atlanta, Georgia, United States
• Clinical Trial Site — Chicago, Illinois, United States
• Clinical Trial Site — Boston, Massachusetts, United States
• Clinical Trial Site — Hackensack, New Jersey, United States
• Clinical Trial Site — Charlotte, North Carolina, United States
• Clinical Trial Site — Columbus, Ohio, United States
• Clinical Trial Site — Houston, Texas, United States
• Clinical Trial Site — Adelaide, Australia
• Clinical Trial Site — Clayton, Australia
• Clinical Trial Site — Heidelberg, Australia
• Clinical Trial Site — Kingswood, Australia
• Clinical Trial Site — Liverpool, Australia
• Clinical Trial Site — Nedlands, Australia
• Clinical Trial Site — Parkville, Australia
• Clinical Trial Site — Parkville, Australia
• Clinical Trial Site — Perth, Australia
• Clinical Trial Site — Westmead, Australia
• Clinical Trial Site — Woolloongabba, Australia
• Clinical Trial Site — Hannover, Germany
• Clinical Trial Site — Hanover, Germany
• Clinical Trial Site — Kiel, Germany
• Clinical Trial Site — Lübeck, Germany
• Clinical Trial Site — London, United Kingdom

Full record on ClinicalTrials.gov

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