FSGS stands for Focal Segmental Glomerulosclerosis. The incidence of FSGS has increased and it is now the most common cause of nephrotic syndrome (a disorder where the kidneys are damaged causing them to leak large amounts of protein into the urine) in North American adults and children. Although there are several known risk factors, we don’t yet know why most people develop FSGS. In order to be diagnosed with FSGS, you must undergo a kidney biopsy.
FSGS is named for the scarring, or “sclerosis”, that can be found in the kidney of people with this disease. When looked at under a microscope, everyone’s kidneys contain millions of tiny filters called “glomeruli”. When these filters are damaged they become scarred and they are no longer able to filter blood appropriately. This is called “glomerulosclerosis”. The word “focal” is added because in FSGS, only some of the filters are damaged. “Segmental” is included because often only parts of the filters are scarred.
Since the waste from blood isn’t filtered completely with FSGS, people affected by the disease can experience protein in the urine, high blood pressure, and swelling (edema). If the disease is not treated or if it does not respond well to attempts at treatment, FSGS can progress to cause kidney damage or failure in 50% of patients. Physicians have previously been unable to predict which patients will progress to these outcomes, however new research has identified biological markers (measurable characteristics) (suPAR and podocyte β3 integrin activation) that may be linked to disease activity and outcomes. Current treatments that suppress the immune system of patients with FSGS have been shown to improve protein leakage and slow the progression of the disease, but side effects of the current options are common and can be serious and rates of treatment failure and relapses are common. This study will look at Rituximab as a new option to treat FSGS and its impact on these biological markers.
The research aims are:
This is a pilot study testing the use of Rituximab therapy in 20 people with FSGS who are either resistant or intolerant to current treatments (steroid and/or calcineurin inhibitors). Study participants will complete a screening and enrollment visit to see if they are eligible to participate. If they are eligible, they will receive two doses of Rituximab approximately 2 weeks apart. Participants will then be evaluated for one year, with study visits at 1, 3, 6 and 12 months after-treatment. All study visits will take place at one of the clinical sites (see the list of participating sites below).
For each visit, you will be asked to:
We will look at your medical records from your local doctor’s office so that we can collect information about your medical history.
To be eligible to participate, you must:
You are not eligible to participate if you have:
In order to participate in a study, you must personally contact the study coordinator of the participating institution closest to you by phone or e-mail. Please use the information below to inquire about participation.
Mayo Clinic, Rochester
Fernando Fervenza, MD, PhD
Julie A. E. Ray, MPH, MEM
University Health Network (UHN), Toronto
Dr. Daniel C. Cattran, MD, FRCP(C)