Imlifidase in ANCA-associated Vasculitis

Conditions

Anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis with severe diffuse alveolar hemorrhage

Brief summary

ANCA seroconversion (indicated by titerbelow reference range) within 24 hours of imlifidase administration

Detailed description

Time to ANCA seroconversion (indicated by ELISA below reference range), Rebound of ANCA serology greater than 50% of the initial fall in titer (i.e. rise > (ANCAmax – ANCAmin) / 2), Mortality (30 days), Duration of ICU stay, Amelioration of lung function o Duration of invasive ventilation / ECMO o Time to resolution of ARDS (measured by Horowitz Index), Amelioration of kidney function o Upstaging of Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury (AKI) stages o Kidney replacement therapy-dependency at 3 and 6 months after inclusion, Safety Endpoint: Frequency and distribution of safety parameters (adverse events (AEs), severe adverse events (SAEs), clinical laboratory tests, vital signs), Safety Endpoint: Frequency and quality of infectious complications

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGIdefirix 11 mg powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
ANCA seroconversion (indicated by titerbelow reference range) within 24 hours of imlifidase administration	—

Secondary

Measure	Time frame
Time to ANCA seroconversion (indicated by ELISA below reference range), Rebound of ANCA serology greater than 50% of the initial fall in titer (i.e. rise > (ANCAmax – ANCAmin) / 2), Mortality (30 days), Duration of ICU stay, Amelioration of lung function o Duration of invasive ventilation / ECMO o Time to resolution of ARDS (measured by Horowitz Index), Amelioration of kidney function o Upstaging of Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury (AKI) stages o Kidney replacement therapy-dependency at 3 and 6 months after inclusion, Safety Endpoint: Frequency and distribution of safety parameters (adverse events (AEs), severe adverse events (SAEs), clinical laboratory tests, vital signs), Safety Endpoint: Frequency and quality of infectious complications	—

Measure

Time frame

Time to ANCA seroconversion (indicated by ELISA below reference range), Rebound of ANCA serology greater than 50% of the initial fall in titer (i.e. rise > (ANCAmax – ANCAmin) / 2), Mortality (30 days), Duration of ICU stay, Amelioration of lung function o Duration of invasive ventilation / ECMO o Time to resolution of ARDS (measured by Horowitz Index), Amelioration of kidney function o Upstaging of Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury (AKI) stages o Kidney replacement therapy-dependency at 3 and 6 months after inclusion, Safety Endpoint: Frequency and distribution of safety parameters (adverse events (AEs), severe adverse events (SAEs), clinical laboratory tests, vital signs), Safety Endpoint: Frequency and quality of infectious complications

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Countries

Germany

Outcome results

None listed