Avacopan is an investigational medicine that is being tested to learn if it may be a potential treatment for patients with C3 glomerulopathy
You may be able to join the study if you:
There are other eligibility criteria that you must meet to participate. The study staff can discuss these criteria with you in greater detail. Visit our “Eligibility” section to find out if you prequalify.
You should talk to your doctor about whether taking part in a clinical trial is right for you.
Study participants will be randomized to receive either an investigational medicine called avacopan or placebo for 26 weeks. During the study, neither you nor your doctor will know the treatment group to which you are assigned. If you receive placebo during the first 26 weeks, you will have the opportunity to receive avacopan for the next 26 weeks.
If you are eligible for, and decide to participate in, the ACCOLADE trial, your participation will last about 60 weeks. During this time, you will be asked to:
Avacopan is an investigational medicine that is being tested to learn if it may be a potential treatment for patients with C3 glomerulopathy. Avacopan is a medication in capsule form that can be taken by mouth, at home.
How does Avacopan work?
In C3 glomerulopathy, the complement system, which is part of the immune system, is not regulated appropriately. This leads to a buildup of complement products in the filtration units of the kidney, causing them to malfunction. One way to treat C3 glomerulopathy may be to block activation of a specific protein that is part of the complement system called the complement 5a receptor (C5aR). Avacopan is an investigational drug that selectively targets this receptor and blocks the activity of C5a.
C3G stands for complement 3 glomerulopathy. In C3G, the complement system, which is part of the immune system, is not regulated appropriately. This leads to over-activation of the immune system and results in deposition of complement products in the filtration units of the kidney called glomeruli. Damaged glomeruli can't filter the blood very well, urine production is reduced and toxins can build up in the blood. As kidney tissue become more damaged, the ability of the kidney to perform other important functions may decline.
There are two kinds of C3 glomerulopathy and both types will be studied in the ACCOLADE trial:
Common signs and symptoms of C3G are blood in the urine (hematuria), excess protein in the urine (proteinuria), reduced glomerular filtration rate (GFR), elevated creatinine, fatigue, and swelling (edema) of hands, feet, and ankles.
Currently, there is no approved treatment for patients with C3 glomerulopathy. Immunosuppressive drugs as well as biologics have been used with limited success.
That’s why the ACCOLADE trial is being conducted. We hope to find a new treatment option that may work for people with C3 glomerulopathy.
National Kidney Foundation:
Avacopan is an investigational medicine that is being tested to learn if it may be a potential treatment for patients with C3 glomerulopathy.
An investigational medication is a medication that is still being studied in clinical trials. It has not been approved for treating patients by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other Regulatory Authority.
There is no cost to you for participating in this research study. The study sponsor pays all the study costs.
Clinical research studies are done to test investigational medications for diseases and conditions. Studies help determine if investigational medications are safe to use and possibly work to improve the health of people. Before any medication can be approved and made available to the general public, it has to go through several phases of clinical research.
Clinical research studies follow a specific set of standards and are closely regulated to help ensure the safety of all participants. Safety precautions are put in place to try and protect people who participate in clinical research. In addition, studies follow a written plan that is called a protocol. The protocol is reviewed by an Institutional Review Board, which is a group of people that is responsible for safeguarding the safety and rights of research subjects. Before you participate in any clinical research study, you will review potential risks and benefits, and the study staff will answer any questions you may have.
Study participation is completely voluntary. You do not need to take part in the study, and you can end your participation at any time, for any reason. If you think you would like to stop participating in the study, talk to the study doctor. If you decide you should leave the study early, the study doctor may ask that you return to the study site for a final visit, but there will be no negative impact on the care you receive.
Please fill out this form to contact us and find out more about the ACCOLADE study.
Your privacy is important to us. Please note that by entering your email and name on this form, you agree to have your contact information sent to the ACCOLADE study. Your contact information will be used only for that purpose and will not be shared with any other party for any other purpose.