Registry for patients with Atypical Hemolytic-Uremic Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This registry collects post-marketing safety data on patients diagnosed with Atypical Hemolytic-Uremic Syndrome (aHUS) who are treated with eculizumab or ravulizumab, as well as those who are untreated. The study aims to gather comprehensive information on the progression of the disease in all enrolled patients, regardless of their treatment status. By documenting patient outcomes and safety data, the registry seeks to enhance understanding of aHUS and improve future treatment strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female patients of any age, including minors, who have been diagnosed with aHUS
* Patients with or without an identified complement pathogenic variant or anti-complement factor antibody
* 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 producing Escherichia coli (STEC).
* Unable to give written informed consent. Patient or patient's parent/legal guardian unable to give written informed consent. Patient (if minor) unable to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees \[IRB/IEC\]).

Where it's running

• Clinical Trial Site
  Aurora, Colorado, United States Recruiting
• Clinical Trial Site
  Washington D.C., District of Columbia, United States Recruiting
• Clinical Trial Site
  Gainesville, Florida, United States Recruiting
• Clinical Trial Site
  Atlanta, Georgia, United States Recruiting
• Clinical Trial Site
  Boston, Massachusetts, United States Recruiting
• Clinical Trial Site
  St Louis, Missouri, United States Recruiting

+91 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Alexion Pharmaceuticals, Inc. (Sponsor)
• Email: clinicaltrials@alexion.com
• Phone: 1-855-752-2356

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ravulizumab Outcomes in Polish Patients with aHUS

  This observational study in Poland follows patients with atypical hemolytic uremic syndrome who are treated with ravulizumab to see how they do over time in real-world clinical care.

  Recruiting at 5 sites AstraZeneca · Gdansk and 9 other locations · NCT07399730

• Ravulizumab for people with clinical aHUS

  This study will test whether ravulizumab raises platelet counts in people diagnosed with clinical atypical hemolytic uremic syndrome (aHUS), including those with certain infections (excluding pneumococcal and STEC), pregnancy/postpartum, recent kidney transplant, malignant hypertension, or autoimmune conditions.

  Recruiting at 3 sites Phase 4 Alexion Pharmaceuticals, Inc. · Bunkyō City and 11 other locations · NCT07308574

• National Registry for Rare Kidney Diseases

  This study is collecting health information from people with rare kidney diseases to help improve treatments and create better care guidelines.

  Recruiting UK Kidney Association · Bristol, South West · NCT06065852

• Using RNA sequencing to diagnose rare genetic diseases

  This study is testing if a new RNA sequencing method can help find the genetic causes of rare diseases in people who haven't been diagnosed after other tests.

  Recruiting Mario Negri Institute for Pharmacological Research · Ranica, BG · NCT05996731

• Switching from anti-C5 antibody treatment to iptacopan for aHUS patients

  This study is testing if switching to a new treatment called iptacopan can help people with atypical hemolytic uremic syndrome (aHUS) feel better after using a different medication.

  Recruiting at 26 sites Phase 3 Novartis · Nanjing, Jiangsu and 30 other locations · NCT05935215

• Understanding rare gene mutations in atypical hemolytic uremic syndrome for personalized therapy

  This study is testing how rare gene mutations in people with atypical hemolytic uremic syndrome can help doctors create personalized treatments to improve their health.

  Recruiting Mario Negri Institute for Pharmacological Research · Ranica, BG · NCT05805202

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.