Aurinia Pharmaceuticals Inc. has started a clinical research study looking at an investigational medication to see if it can help people with Primary Focal Segmental Glomerulosclerosis (FSGS).
We are looking for approximately 20 participants with biopsy confirmed primary FSGS to be enrolled in this study at multiple sites in the United States.
Participants will receive the investigational drug voclosporin as a study drug for 24 weeks and are expected to attend about 10 to 12 clinic visits over the course of the study period. Study assessments, study drugs and procedures will be provided at no cost to participants.
The aim of the current study is to investigate whether voclosporin, given alone or with steroids, over a period of 24 weeks is able to reduce disease activity. Participants who have had a kidney biopsy showing evidence of primary FSGS with proteinuria will be eligible to enter the study.
Aurinia Pharmaceuticals may provide support for participants to assist with transportation to sites conducting this trial.
Voclosporin (VCS) is an investigational drug currently under development by Aurinia Pharmaceuticals Inc. for use in FSGS and Lupus Nephritis (LN). Voclosporin belongs to a class of medications called immunosuppressants. Voclosporin is not commercially available and is not approved as safe or effective for any use by any national or foreign drug regulatory authority. However, over 2000 people (healthy volunteers, kidney transplant, psoriasis, and uveitis participants) have taken voclosporin in clinical trials. A phase 2 clinical trial to examine the use of voclosporin in achieving complete remission in patients with active lupus nephritis was recently completed and a phase 3 clinical trial in lupus nephritis is currently ongoing.
FSGS is a rare disease that attacks the kidney’s filtering units (glomeruli) causing serious scarring which leads to permanent kidney damage and even failure. FSGS is one of the causes of a serious condition known as Nephrotic Syndrome.
Each kidney is made up of approximately one million tiny filters called “glomeruli.” Much as a coffee filter keeps coffee grounds in, glomeruli filter the blood, taking out the water-like part which becomes urine and leaving the protein in the blood. When glomeruli become damaged or scarred (sclerosis), proteins begin leaking into the urine (proteinuria). The word “focal” is added because in FSGS, only some of the glomeruli filters become scarred. “Segmental” means that only some sections of the glomerulus becomes scarred, just parts of them.
Some people do not have any symptoms of FSGS and may not know they have it. No one knows what causes primary FSGS although some research suggests there is a genetic link. FSGS is diagnosed by a kidney biopsy. This is a procedure where a doctor takes one or more tiny pieces of your kidney to look at with special microscopes.
Eligible participants will need to visit the study site about 10 to 12 times. The study period is expected to last about 6 months. Tests and assessments will be conducted to monitor the participants health. These will include: