This is an observational research study for adults and pediatric patients aged 8 years and older who have been identified as receiving treatment with FILSPARI® (sparsentan). FILSPARI has been approved by the U.S. Food and Drug Administration (FDA) to slow the decline of kidney function in adult patients with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression and to reduce proteinuria in adults and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.
An observational research study means participants will continue to receive care as decided by their healthcare providers. Participation in this study will not change participants' treatment or medical care in any way.
You are being invited to take part in this observational research study because you have been identified as being treated with FILSPARI® (sparsentan). FILSPARI is approved by the U.S. Food and Drug Administration (FDA) to help slow the decline of kidney function in adults with immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. It is also approved to reduce proteinuria (excess protein in the urine) in adults and children aged 8 years and older with focal segmental glomerulosclerosis (FSGS) who do not have nephrotic syndrome.
The SPARKLER Study is sponsored by Travere Therapeutics, Inc which is responsible for the initiation and financing of the study. Travere Therapeutics has contracted United BioSource, LLC (UBC) to manage the day-to-day activities of the study.
The purpose of this study is to collect any potential liver-related problems that people may experience while taking FILSPARI.
Your participation in this study will last approximately 2 years. Every 3 months we'll request a brief health update from your doctor including:
We may contact you if we can't reach your doctor or need clarification.
The information that is collected from this observational study will assist in assessing whether FILSPARI may cause Drug-Induced Liver Injury (DILI). It is not known whether FILSPARI causes DILI, which is why it's important to collect the data in this observational study to help us understand more about whether patients are more likely to experience these liver events.
Participants may help others by increasing the understanding of the potential for drug induced liver injury in patients treated with FILSPARI. Participation may benefit patients in the future by providing new safety and medical information.
Your participation in the study is strictly voluntary. You may withdraw from the study at any time.
To participate in this study, participants must:
If you are interested in participating in the SPARKLER Study, please provide your contact information so a member of the study team can follow up with you.
Call 1-866-974-3979
Hours of Operation: Monday-Friday, 9:00am – 5:00pm, ET
Thank you for your interest in the SPARKLER Study, sponsored by Travere. Someone from the study team will contact you about your participation within 2 business days.