Recruiting
Sponsor ID
20220159
A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
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
Brookview Hills Research Associates Llc
Winston-Salem, NC, United States, 27103
Status
Recruiting
Location
East Carolina University Brody Outpatient Center
Greenville, NC, United States, 27834
Status
Recruiting
Location
Mayo Clinic
Rochester, MN, United States, 55905
Status
Recruiting
Location
Virginia Mason Medical Center
Seattle, WA, United States, 98101
Status
Terminated
Location
Stat Research
Miamisburg, OH, United States, 45342
Status
Recruiting
Location
Southwest Kidney Institute
Surprise, AZ, United States, 85374
Status
Recruiting
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