Recruiting
Sponsor ID
20220159
A Study to Evaluate Avacopan in Participants With ANCA-associated VasculitisAVASET
Study Details
The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
Protocol Summary
Primary Outcome Measures
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to Month 60
Percentage of Participants Experiencing Adverse Events of Special Interest
Timeframe: Up to Month 60
Percentage of Participants Experiencing Serious Adverse Events
Timeframe: Up to Month 60
Percentage of Participants Experiencing Adverse Events Leading to Withdrawal
Timeframe: Up to Month 60
Percentage of Participants Experiencing Adverse Events Leading to Death
Timeframe: Up to Month 60
Number of Participants Experiencing Clinical Significant Changes from Baseline in Vital Signs Measurements
Timeframe: Up to Month 60
Number of Participants Experiencing Clinical Significant Changes from Baseline in Hematology Assessments
Timeframe: Up to Month 60
Number of Participants Experiencing Clinical Significant Changes from Baseline in Serum Chemistry Assessments
Timeframe: Up to Month 60
Number of Participants Experiencing Clinical Significant Changes from Baseline in Urinalysis Assessments
Timeframe: Up to Month 60
Secondary Outcome Measures
Group A and B Participants who Achieved Remission at Month 12: Time to Relapse in AAV Between Month 12 and Month 60
Timeframe: Month 12 to Month 60
Group A and B Participants who Achieved Remission at Month 12: Percentage of Participants who Relapse After Achieving Remission at Month 12
Timeframe: Month 12 to Month 60
Groups A and C: Percentage of Participants who Achieved Sustained Remission at Month 60
Timeframe: Month 60
Group A and C Participants with Overt Renal Disease at Baseline: Change from Baseline to Month 60 in Estimated Glomerular Filtration Rate (eGFR)
Timeframe: Baseline and Month 60
Groups A and C: Change from Baseline to Month 60 in Short Form 36 Health Survey Version 2 (SF-36 v2) General Health Perception Score
Timeframe: Baseline and Month 60
Groups A and C: Change from Baseline to Month 60 in EuroQoL-5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS)
Timeframe: Baseline and Month 60
Percentage of Participants who Achieved Remission at Month 6
Timeframe: Month 6
Groups A and C: Change from Baseline to Month 60 in Vasculitis Damage Index (VDI)
Timeframe: Baseline and Month 60
Groups A and C: Percentage of Participants with Composite Outcome of Initiation of Maintenance Dialysis, Kidney Transplantation, or Death
Timeframe: Up to Month 60
Percentage of Participants With Glucocorticoid Use
Timeframe: Up to Month 60
Percentage of Participants With Immunosuppressant Use
Timeframe: Up to Month 60
Locations
Location
Harbor University of California at Los Angeles Medical Center
Torrance, CA, United States, 90502
15.6 miles (25.0 km) away from your location
Status
Recruiting
Location
Medvin Clinical Research
Covina, CA, United States, 91722
19.4 miles (31.0 km) away from your location
Status
Terminated
Location
Providence Medical Foundation
Fullerton, CA, United States, 92835
20.7 miles (33.1 km) away from your location
Status
Recruiting
Location
Amicis Research Center
Valencia, CA, United States, 91355
33.2 miles (53.1 km) away from your location
Status
Recruiting