Avacopan in Patients with C3 Glomerulopathy
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy
IRAS ID
234786
Contact name
David Kavanagh
Contact email
Sponsor organisation
ChemoCentryx, Inc.
Eudract number
2017-001821-42
Duration of Study in the UK
2 years, 2 months, 0 days
Research summary
Summary of Research
Avacopan is an investigational medicinal product being developed by ChemoCentryx, Inc. and is being studied for the treatment of a certain type of vasculitis, called ANCA-Associated Vasculitis (AAV).
In C3 glomerulopathy, part of the immune system is not regulated appropriately. This leads to over-activation of the system, resulting in deposition of complement products in the filtration units of the kidney. One way to treat C3 glomerulopathy may be to regulate the action of a specific protein that is part of the complement system called C5a on its receptor. Avacopan is a medicinal product that directly targets this receptor and blocks the activity of C5a. Patients with C3G often have progressive deterioration in kidney function, ultimately leading to end-stage kidney disease.
Currently, there is no approved treatment for patients with C3 glomerulopathy. Immunosuppressive drugs such as cyclophosphamide, mycophenolate mofetil, and glucocorticoids, as well as biologics have been used with limited success. Avacopan is in Phase 3 clinical development for treatment of patients with anti-neutrophil cytoplasmic AAV. Phase 2 study data with avacopan in patients with AAV indicate effectiveness with avacopan given twice daily, based on improvement in disease activity, a significant anti- proteinuric effect (reduction of protein in the urine), and improvement in quality of life among other improved disease parameters. This treatment effect was observed in subjects receiving avacopan plus cyclophosphamide or rituximab, but with no oral glucocorticoids. This provides support for testing drugs that targets the C5a receptor, such as avacopan.
This study is being done to evaluate the effect and safety of avacopan on kidney disease activity in subjects with C3 glomerulopathy compared with a placebo for the first part of the study. This study will also assess the safety of avacopan. Safety is based on physical examinations, the side effects and safety laboratory changes over the course of the study.Summary of Results
https://www.clinicaltrials.gov/ct2/show/NCT03301467?term=CL011_168&draw=2&rank=1
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
18/NE/0052
Date of REC Opinion
24 Apr 2018
REC opinion
Further Information Favourable Opinion