A Retrospective Study to Evaluate the Clinical Outcome According to Treatment in aHUS Patients in South Korea

Study Overview
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Brief Summary
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Primary objective - To determine the clinical prognosis by identifying the disease course and severity by treatment with or without eculizumab in patients with aHUS in Korea. Secondary objectives To determine the clinical prognosis of the disease in all patients with aHUS in Korea. To determine the clinical prognosis of the disease in patients diagnosed with aHUS prior to the initiation of eculizumab reimbursement system in Korea. To determine the treatment responses by treatment options in patients with aHUS in Korea. To identify risk factors that affect mortality in all patients with aHUS in Korea. To investigate the recurrence and clinical prognosis in patients with aHUS in Korea when eculizumab is discontinued

Detailed Description
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As a retrospective, non-interventional, multi-center study

Official Title
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A Retrospective Study to Evaluate the Clinical Outcome According to Treatment in Atypical Hemolytic Uremic Syndrome (aHUS) Patients in South Korea

Conditions
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aHUS

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are clinically diagnosed with the aHUS Exclusion Criteria: Patients who are diagnosed with Shiga toxin-producing E. coli hemolytic-uremic syndrome (STEC-HUS). Patients with less than 10% in a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS-13) activity test
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical prognosis (Renal survival) by treatment with or without eculizumab | Renal survival (end-stage renal disease [ESRD]-free survival) | from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, or date of ESRD diagnosis, whichever came first | 
| Clinical prognosis (Overall survival) by treatment with or without eculizumab | Overall survival (OS) | from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, whichever came first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical prognosis (Renal survival) of all aHUS patients in Korea | Renal survival (ESRD-free survival) | from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, or date of ESRD diagnosis, whichever came first | 
| Clinical prognosis (Overall survival) of all aHUS patients in Korea | Overall survival (OS) | from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, whichever came first | 
| Clinical prognosis (Renal survival) of patients diagnosed with aHUS prior to the initiation of eculizumab reimbursement system in Korea | Renal survival (ESRD-free survival) | from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, or date of ESRD diagnosis, whichever came first | 
| Clinical prognosis (Overall survival) of patients diagnosed with aHUS prior to the initiation of eculizumab reimbursement system in Korea | Overall survival (OS) | from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, whichever came first | 
| Response rates of each treatment, compared to prior to start treatment | Complete response of TMA | 3rd and 6th months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aHUS, eculizumab