A new study by Retrophin is giving patients hope about a potential treatment for Focal Segmental Glomerulosclerosis (FSGS)
The DUET study will evaluate the safety and effectiveness of an investigational medication, called RE-021 or sparsentan, in patients with focal segmental glomerulosclerosis (FSGS). The goal is to learn whether the investigational medication may change the amount of protein in the urine and decrease proteinuria.
Study participation may last up to approximately 39 months and include up to 18 study visits to the study site. Participants will have tests and evaluations at the study visits.
FAQ
What is the DUET study?
The DUET study will evaluate the safety and effectiveness of an investigational medication in patients with focal segmental glomerulosclerosis (FSGS). The goal is to learn whether the investigational medication may decrease proteinuria.
Who can participate?
You may be eligible to participate in the DUET study if you:
- Are 8 to 75 years of age
- Have a confirmed diagnosis of primary FSGS
- Do not have a history of heart disease, diabetes, hepatitis, HIV, or organ transplant
What is the investigational medication?
The investigational study medication, called RE-021 or sparsentan, will be compared to a drug called irbesartan, which is FDA approved to treat high blood pressure and kidney disease caused by diabetes. Irbesartan is also commonly prescribed for patients with proteinuria.
How long will the study last?
Study participation may last up to approximately 39 months and include up to 18 study visits to the study site. Participants will have tests and evaluations at the study visits.
Does it cost anything to participate?
The investigational study medication and study-related tests and evaluations will be provided at no cost, and participants will be reimbursed for travel expenses.
What are the potential risks and benefits?
Everyone who participates in a research study must first complete a screening visit. During the screening visit, the study doctor will explain the study details and the potential risks and benefits of participation in the study.
The information learned from the study and your participation may help us learn about how to develop future treatment options for people with FSGS.
Study participation is voluntary. If you choose to participate, you may leave the study at any time for any reason. The study doctor and staff will be available to help you throughout the study and to address any questions you may have. Your health is very important to them.
To learn more about the DUET study and to see if there are sites located near you, call 877-659-5518
or visit: http://www.fsgsduetstudy.com/
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