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Observational study of treatment patterns and outcomes in atypical hemolytic uremic syndrome patients

A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Chinese Atypical Hemolytic Uremic Syndrome Patients

Observational AstraZeneca · NCT06099236

This study looks at how different treatments for atypical hemolytic uremic syndrome affect both children and adults in China over a year.

Quick facts

Study typeObservational
Enrollment1070 (estimated)
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionseculizumab
Locations45 sites (Beijing, Beijing and 44 other locations)
Trial IDNCT06099236 on ClinicalTrials.gov

What this trial studies

This observational study will enroll pediatric and adult patients diagnosed with atypical hemolytic uremic syndrome (aHUS) in China. Participants will be treated according to local clinical guidelines, with those receiving supportive therapy monitored for up to 12 months. Patients initiated on eculizumab treatment will be followed for an additional 12 months. The study aims to describe patient characteristics, treatment patterns, outcomes, and safety for all enrolled patients.

Who should consider this trial

Good fit: Ideal candidates include patients of any age diagnosed with aHUS who meet specific laboratory criteria.

Not a fit: Patients who do not have a confirmed diagnosis of aHUS or do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the treatment patterns and outcomes of aHUS, potentially improving patient management.

How similar studies have performed: While this study follows established observational methodologies, similar studies have shown success in understanding treatment patterns in rare diseases.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Participants are eligible to be included in the study. Age

1. Patients of any age, who are diagnosed as aHUS by a professional physician (first epi-sode or relapse).

   Type of Patient and Disease Characteristics
2. Evidence of TMA, including thrombocytopenia, evidence of hemolysis, and kidney dys-function, based on the following laboratory findings, should be recorded within 1 week time frame:

   1. Platelet count \< 150 per microliter (μL), and
   2. Mechanic hemolytic anemia evident by LDH ≥ 1.5 × upper limit of normal (ULN), and hemoglobin ≤ lower limit of normal (LLN) for age and gender and
   3. Serum creatinine level ≥ ULN in adults (≥18 years of age), or ≥ 97.5th percentile for age at screening in children (patients who require dialysis for acute kidney injury are also eligi-ble).
3. Gender: Male and/or female.. Informed Consent
4. Willing and able to give written informed consent and comply with the study visit schedule as described in Section 6.2.1. For patients \< 18 years of age, patient's legal guardian must be willing and able to give written informed consent and the patient must be willing to give written informed assent (if applicable as determined by the central.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

Medical Conditions

1. Patients who were diagnosed with HUS only due to Shiga toxin-producing Escherichia coli (STEC).
2. Patients who were diagnosed with TTP (ADAMTS13 activity \<10%). Other Exclusions
3. Unable to give written informed consent.
4. Any medical or psychological condition that, in the opinion of the Investigator, could increase the risk to the participant by participating in the study or confound the outcome of the study.

Where this trial is running

Beijing, Beijing and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atypical Hemolytic Uremic Syndrome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.