ClinicalTrials.gov record NCT07399730

Ravulizumab Outcomes in Polish Patients With aHUS

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

A Non-interventional Study Evaluating Ravulizumab Treatment Outcomes in Polish Patients With Atypical Hemolytic Uremic Syndrome

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
SexAll
LocationPoland
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This non-interventional study collects past medical records and follows people with atypical hemolytic uremic syndrome (aHUS) who received ravulizumab as part of routine care. It includes a prospective group new to complement inhibitors and a retrospective group switched from other complement inhibitors. The study records clinical outcomes, lab results, quality-of-life and fatigue scores for up to 24 months.

What it is studying. The study is gathering real-world, longitudinal data on how patients with aHUS who receive ravulizumab are managed and what clinical outcomes they experience. Key outcomes measured include complete thrombotic microangiopathy (TMA) response and time to response, dialysis dependence, kidney function and proteinuria changes, and patient-reported fatigue and quality-of-life over follow-up.

What the researchers hope to learn. To describe and quantify treatment outcomes and clinical course of ravulizumab-treated aHUS patients, including rates and timing of complete TMA response, proportions remaining dialysis-free, changes in kidney function and proteinuria, and changes in fatigue and quality-of-life measures over time.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This multicenter, observational cohort study uses retrospective collection of past medical history and prospective follow-up to capture longitudinal data on the management and clinical outcomes of patients with atypical hemolytic uremic syndrome (aHUS) treated with ravulizumab as part of routine clinical practice under Poland's National Drug Program (NDP).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Ravulizumab

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Patients of all ages diagnosed with atypical hemolytic uremic syndrome (aHUS) who received treatment with ravulizumab under the National Drug Program (NDP) in Poland.
  • Patients who are willing to participate in the study and have provided informed consent by signing the informed consent form (ICF).

Exclusion criteria

  • Individuals who intend to participate in a clinical trial for atypical hemolytic uremic syndrome (aHUS) on or after the date of their first ravulizumab infusion through the National Drug Program.
  • Patients with cognitive impairments, those who are unwilling to participate, or those facing language barriers that hinder adequate comprehension or cooperation.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

The study collects past medical records and prospectively follows people who are being treated with ravulizumab as part of routine care, with follow-up data collected for up to 24 months. Participants provide informed consent, allow review of their medical history, and attend periodic follow-up assessments that may include routine blood and urine tests, kidney-function and dialysis-status checks, and questionnaires about fatigue and quality of life. The study does not assign experimental treatment; it records outcomes of ravulizumab given in routine care.

How the study is structured. Non-interventional observational cohort study using both retrospective chart review and prospective follow-up. Participants are in two groups: a prospective cohort of people who are new to complement inhibitor therapy and a retrospective cohort of people switched from other complement inhibitors to ravulizumab. No treatment is assigned by the study; ravulizumab use reflects routine clinical care. Outcomes are followed and recorded for up to 24 months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Poland. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on atypical hemolytic uremic syndrome

Important dates

Study start
Jun 24, 2026
Primary completion
Sep 30, 2029 (estimated)
Study completion
Sep 30, 2029 (estimated)
Target enrollment
80 participants (estimated)
Last updated on registry
Sep 15, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
AstraZeneca

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (10)

  • Research SiteNot Yet Recruiting

    Gdansk · Poland

  • Research SiteNot Yet Recruiting

    Katowice · Poland

  • Research SiteRecruiting

    Katowice · Poland

  • Research SiteNot Yet Recruiting

    Krakow · Poland

  • Research SiteRecruiting

    Lodz · Poland

  • Research SiteRecruiting

    Poznan · Poland

  • Research SiteNot Yet Recruiting

    Warsaw · Poland

  • Research SiteRecruiting

    Warsaw · Poland

  • Research SiteNot Yet Recruiting

    Wroclaw · Poland

  • Research SiteRecruiting

    Wroclaw · Poland

Terms used on this page · explanations by MedicalUpdates.ai

follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
clinical trial
A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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