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

aHUS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05405777
• Other study ID #: HD-ECU-501
• Status: Not yet recruiting
• Start date: June 14, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: June 2022
• Source: Handok Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• aHUS

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Handok Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Response rates of each treatment, compared to prior to start treatment	Complete response of TMA	3rd and 6th months