Avacostar - (PASS)

ANCA-associated Vasculitis Clinical Trial

— Avacostar  

Official title:

Avacostar - A Post Authorization Safety Study (PASS) to Evaluate the Incidence of Safety Events of Interest in Patients Treated With Avacopan for ANCA-associated Vasculitis (AAV)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05897684
• Other study ID #: CS-AVA-2022-0016
• Status: Recruiting
• Start date: September 11, 2023
• Est. completion date: December 1, 2030

Study information

• Verified date: May 2024
• Source: Vifor Fresenius Medical Care Renal Pharma
• Contact: Avacostar Study Team
• Phone: +41 58 851 80 00
• Email: clinicaltrials[@]cslbehring.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2030
• Est. primary completion date: December 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Concurrent participation in an interventional study, unless prospectively discussed and agreed with the Medical Monitor.

Related Conditions & MeSH terms

• ANCA-associated Vasculitis
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Vasculitis

Locations

Country	Name	City	State
Germany	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
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Vifor Fresenius Medical Care Renal Pharma

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the incidence of defined MESIs	To evaluate the incidence of defined MESIs in patients with AAV commencing avacopan. MESIs include liver injury, cardiac safety, serious infection, and malignancy.	up to 7 years
Secondary	Incidence rates of AE in the avacopan and non-avacopan groups		up to 7 years
Secondary	AEs leading to discontinuation of therapy in the avacopan group		up to 7 years
Secondary	Incidence of SAEs in the avacopan and non-avacopan groups		up to 7 years
Secondary	Incidence of ADRs in the avacopan group		up to 7 years
Secondary	Incidence of SADRs in the avacopan group		up to 7 years
Secondary	Change in eGFR over time in the avacopan and non-avacopan groups		up to 7 years
Secondary	Change in IgG over time in the avacopan and non-avacopan groups		up to 7 years
Secondary	Change in CPK over time in the avacopan and non-avacopan groups		up to 7 years
Secondary	Change in ALT over time in the avacopan and non-avacopan groups		up to 7 years
Secondary	Change in AST over time in the avacopan and non-avacopan groups		up to 7 years
Secondary	Change in billirubin over time in the avacopan and non-avacopan groups		up to 7 years
Secondary	Change in WBC over time in the avacopan and non-avacopan groups		up to 7 years
Secondary	Change Albumin over time in the avacopan and non-avacopan groups		up to 7 years
Secondary	Time to first flare over time in the avacopan and non-avacopan groups	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	up to 7 years
Secondary	Change in VDI scores over time in the avacopan and non-avacopan groups		up to 7 years
Secondary	Incidence of MESIs in the non-avacopan group		up to 7 years
Secondary	Incidence rates of SAEs and MESIs in the avacopan group compared to the non-avacopan group,		up to 7 years
Secondary	Incidence rates of MESIs in the avacopan group compared to the non-avacopan group,		up to 7 years
Secondary	Use of concomitant immunosuppression over time and cumulative by treatment group,		up to 7 years
Secondary	Duration of GC-free periods		up to 7 years
Secondary	Proportion of GC-free patients over time by treatment group.		up to 7 years
Secondary	Duration of treatment with avacopan by reason for treatment discontinuation.		up to 7 years