Avacostar - (PASS)
- Conditions
- ANCA-associated Vasculitis
- Registration Number
- NCT05897684
- Lead Sponsor
- Vifor Fresenius Medical Care Renal Pharma
- Brief Summary
The Avacostar PASS is a non-interventional, multi-national, prospective cohort study that will collect data from 2 cohorts of patients: those treated with avacopan for active severe AAV, and a second cohort treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active severe AAV. The overall study duration is anticipated to be up to 7 years, including a recruitment period of approximately 3 years.
- Detailed Description
The Avacostar PASS is a non-interventional, multi-national, prospective cohort study that will collect data from 2 cohorts of patients: those treated with avacopan for active severe AAV, and a second cohort treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active severe AAV. The overall study duration is anticipated to be up to 7 years, including a recruitment period of approximately 3 years. Enrolled patients will be followed until the last patient last visit (LPLV) milestone, which will be 4 years after the last participant is enrolled.
Germany and the United Kingdom (UK) have been selected for the study. Additional countries may be considered according to availability of avacopan and suitability for the study. Patients will be enrolled prospectively, but up to 6 months of data may be collected retrospectively if necessary. Baseline visit is defined as the day that induction treatment (avacopan or non-avacopan standard of care (SoC) cyclophosphamide or rituximab) is started for active severe AAV. Patients who started avacopan/SoC induction therapy for active severe AAV within 6 months of the enrolment visit and fulfil eligibility criteria may be enrolled in the PASS. Individual participant follow-up data will be collected periodically at routine clinic visits until the LPLV, which will be 4 years after the last participant is enrolled.
The primary objective of the study is:
To evaluate the incidence of defined Medical Events of Special Interest (MESIs) in patients with AAV commencing avacopan.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Diagnosis of AAV (MPA or GPA), as determined by the Investigator according to their usual practice.
- Active, severe AAV at the time of commencing avacopan or non-avacopan SoC induction therapy, in the opinion of the Investigator.
- Age ≥18 years of either sex.
- Has provided written informed consent.
- Has commenced within the previous 6 months, or is planned to commence avacopan, cyclophosphamide or rituximab for the treatment of severe, active AAV outside of an interventional clinical study.
• Concurrent participation in an interventional study, unless prospectively discussed and agreed with the Medical Monitor.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the incidence of defined MESIs up to 7 years To evaluate the incidence of defined MESIs in patients with AAV commencing avacopan. MESIs include liver injury, cardiac safety, serious infection, and malignancy.
- Secondary Outcome Measures
Name Time Method Incidence rates of AE in the avacopan and non-avacopan groups up to 7 years AEs leading to discontinuation of therapy in the avacopan group up to 7 years Change in AST over time in the avacopan and non-avacopan groups up to 7 years Change in WBC over time in the avacopan and non-avacopan groups up to 7 years Change Albumin over time in the avacopan and non-avacopan groups up to 7 years Incidence rates of MESIs in the avacopan group compared to the non-avacopan group, up to 7 years Use of concomitant immunosuppression over time and cumulative by treatment group, up to 7 years Duration of GC-free periods up to 7 years Proportion of GC-free patients over time by treatment group. up to 7 years Incidence of ADRs in the avacopan group up to 7 years Change in eGFR over time in the avacopan and non-avacopan groups up to 7 years Change in ALT over time in the avacopan and non-avacopan groups up to 7 years Change in billirubin over time in the avacopan and non-avacopan groups up to 7 years Incidence of SADRs in the avacopan group up to 7 years Incidence of MESIs in the non-avacopan group up to 7 years Incidence rates of SAEs and MESIs in the avacopan group compared to the non-avacopan group, up to 7 years Duration of treatment with avacopan by reason for treatment discontinuation. up to 7 years Incidence of SAEs in the avacopan and non-avacopan groups up to 7 years Change in IgG over time in the avacopan and non-avacopan groups up to 7 years Change in CPK over time in the avacopan and non-avacopan groups up to 7 years Change in VDI scores over time in the avacopan and non-avacopan groups up to 7 years Time to first flare over time in the avacopan and non-avacopan groups up to 7 years A flare is defined in the BVAS as a score of more than 0. No flare is defined as a BVAS score equal to 0
Trial Locations
- Locations (35)
Charité University Medicine
🇩🇪Berlin, Germany
University Hospital of Cologne
🇩🇪Cologne, Germany
Municipal Hospital Dresden
🇩🇪Dresden, Germany
University Hospital Essen
🇩🇪Essen, Germany
University Hospital Freiburg
🇩🇪Freiburg, Germany
University Medical Center Göttingen
🇩🇪Göttingen, Germany
University Hospital Eppendorf
🇩🇪Hamburg, Germany
KRH Klinikum Siloah
🇩🇪Hannover, Germany
Rheumazentrum Ruhrgebiet
🇩🇪Herne, Germany
LMU
🇩🇪Munich, Germany
Medius Kliniken
🇩🇪Plochingen, Germany
St. Josef-Stift Sendenhorst
🇩🇪Sendenhorst, Germany
UHB NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
🇬🇧Bradford, United Kingdom
North Bristol NHS Trust
🇬🇧Bristol, United Kingdom
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
East Kent Hospitals University NHS FT
🇬🇧Canterbury, United Kingdom
Cardiff and Vale UHB
🇬🇧Cardiff, United Kingdom
Epsom & St. Helier NHS Trust
🇬🇧Carshalton, United Kingdom
University Hospitals Coventry and Warwickshire
🇬🇧Coventry, United Kingdom
Royal Devon University Healthcare NHS Foundation Trust
🇬🇧Exeter, United Kingdom
NHS Greater Glasgow & Clyde
🇬🇧Glasgow, United Kingdom
University Hospitals of Leicester NHS Trust
🇬🇧Leicester, United Kingdom
Barts Health
🇬🇧London, United Kingdom
Hammersmith Hospital, Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
Royal Free
🇬🇧London, United Kingdom
St Thomas' Hospital
🇬🇧London, United Kingdom
Manchester University NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Nottingham university hospitals NHS trust
🇬🇧Nottingham, United Kingdom
Rheumatology Department, Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom
Royal Berkshire NHS foundation trust
🇬🇧Reading, United Kingdom
Northern Care Alliance
🇬🇧Salford, United Kingdom
Swansea Bay University LHB
🇬🇧Swansea, United Kingdom
York & Scarborough Teaching Hospitals NHS FT
🇬🇧York, United Kingdom