An observational study in Atypical Hemolytic Uremic Syndrome, sponsored by AstraZeneca. Recruiting at 10 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by AstraZeneca · Observational
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Among 19 studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca — 4 open to participants now, 5 under way, none of them phase 3. Atypical Hemolytic Uremic Syndrome · AstraZeneca.
Among the 19 studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca, this one is the only one that started in 2026, is one of 9 observational ones, and was the 19th registered.
45 studies on the registry are indexed under Atypical Hemolytic Uremic Syndrome; 14 are open to participants now.
Browse Atypical Hemolytic Uremic Syndrome studies →4 of the 19 studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
Alexion Pharmaceuticals, Inc. · Sites in Japan
Ages 18+
Alexion Pharmaceuticals, Inc. · Sites in United States, Australia, France and 4 more countries
Women only
Alexion Pharmaceuticals, Inc. · Sites in United States, Australia, Belgium and 14 more countries
By country, each count listing its studies:
Of the 12 Atypical Hemolytic Uremic Syndrome studies recruiting now, 10 (83%) set no upper age limit and none (0%) stop at 75 or younger; 6 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 80 is close to the median of 80 across 15 observational studies indexed under Atypical Hemolytic Uremic Syndrome.
Median enrollment 18 across the 10 interventional studies, 80 across the 9 observational. Of the 14 that completed or were terminated, 9 (64%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
1 of the studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07308574Alexion Pharmaceuticals, Inc.Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS | 2027-06-25 |
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Among the 19 studies in Atypical Hemolytic Uremic Syndrome by AstraZeneca, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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).
Consecutive patients naïve to complement inhibitors (prospective cohort) with a body weight of 10 kg or above (no age restrictions) diagnosed with atypical haemolytic uremic syndrome and meeting all ravulizumab treatment eligibility criteria listed in NDP - no previous exposition to CIs including clinical trials, EAP etc.
Patients who have been switched to ravulizumab from other CI (retrospective cohort) with a body weight of 10 kg or above (no age restrictions) diagnosed with atypical haemolytic uremic syndrome and meeting all ravulizumab treatment eligibility criteria listed in NDP.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group of patients naive to complement inhibitors
Drug: Ravulizumab
Group of patients who transitioned from other complement inhibitors to ravulizumab.
Drug: Ravulizumab
Ultomiris
Proportion of patient attaining Complete Thrombotic Microangiopathy (TMA) Response during observation (naïve)
In order to achieve the primary objectives, the following variables will be estimated: To assess ravulizumab primary treatment outcome in Polish patients with aHUS
Time frame: Up to 24 months
Proportion of patients attaining/maintaining. Complete TMA Response during observation (switched)
In order to achieve the primary objectives, the following variables will be estimated: To assess ravulizumab primary treatment outcome in Polish patients with aHUS
Time frame: Up to 24 months
Time to Complete TMA Response
Time from initiation of ravulizumab to TMA Response: continuous variable (days; specify when complete response criteria are met)
Time frame: Up to 24 months
Proportion of dialysis-free patients
In order to achieve the secondary objectives, the following variables will be estimated
Time frame: Up to 24 months
Complete TMA response
In order to achieve the secondary objectives, the following variables will be estimated: * Platelet count (≥150 x 109/L) * Lactate dehydrogenase (LDH) levels (≤ULN) * Serum creatinine (≤ULN for age or an improvement \> 25% compared to baseline),
Time frame: Up to 24 months
Proportion of patients with lab results normalization during observation
Laboratory Parameters: * platelet count (≥150 x 109/L)\*, * lactate dehydrogenase (LDH) levels (≤ULN), * serum creatinine (≤ULN for age or an improvement \> 25% compared to baseline), * serum creatinine improvement of \>50% compared to baseline * estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2, * increase in haemoglobin of ≥ 20 g/L
Time frame: Up to 24 months
Change from baseline in CKD stage, as evaluated by the physician over time
In order to achieve the secondary objectives, the following variables will be estimated: CKD stage 1 (rather theoretical at baseline, possible following successful treatment): eGFR ≥90 ml/min./1.73m2 CKD stage 2 (rather theoretical at baseline, possible following successful treatment): eGFR 60 - 90 ml/min./1.73m2 CKD stage 3a: eGFR 45 - 59 ml/min./1.73m2 CKD stage 3b: eGFR 30 - 44 ml/min./1.73m2 CKD stage 4: eGFR 15 - 29 ml/min./1.73m2 CKD stage 5: eGFR\< 15 ml/min./1.73m2 CKD stage 5D: need for dialysis independent from eGFR value
Time frame: Up to 24 months
Change from baseline in proteinuria status over time
In order to achieve the secondary objectives, the following variables will be estimated: At least one of the following numbers describing the highest proteinuria and/or albuminuria: * urine protein-to-creatinine ratio \[mg/g\] (preferred) * urine protein loss \[mg/24 hours\] * urine protein concentration \[mg/dl\] * urine albumin-to-creatinine ratio \[mg/g\] (preferred) * urine albumin loss \[mg/24 hours\] Urine protein reduction to ≤ 500 mg/g (500 mg/24 hours) Urine protein reduction by ≥50% from baseline Time to urine protein reduction to ≤ 500 mg/g (500 mg/24 hours) Time to urine protein reduction by ≥50% from baseline
Time frame: Up to 24 months
Change from baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue; adults) and Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (Peds FACIT-F; pediatric patients) score overtime (naïve)
FACIT-Fatigue - scoring ranges from 0 (highest fatigue) to 52 (lowest fatigue), where higher scores indicate lower levels of fatigue. Peds FACIT-F - scoring ranges from 0 (highest fatigue) to 52 (lowest fatigue), where higher scores indicate lower levels of fatigue.
Time frame: Up to 24 months
Change form baseline in EQ- 5D-5L (adults) and EQ-5D-Y- 5L (paediatric patients) score overtime (naïve)
EQ-5D-5L/EQ-5D-Y-5L consists of 2 pages: EQ-5D descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D/EQ-5D-Y comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. EQ VAS - scale rating from 0 (worst imaginable health state) to 100 (best imaginable health state)
Time frame: Up to 24 months
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Sep 2029, 39 months after the start.
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Atypical Hemolytic Uremic Syndrome →