This is an observational research study for adults who have been identified as being treated with the drug FILSPARI® (sparsentan), which has been approved by the Food and Drug Administration (FDA) to reduce levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN), and who are at risk of their disease progressing quickly.
An observational research study means participants will continue to receive care as decided by their healthcare providers. Participation in this study will not change treatment or medical care in any way.
You are being asked to participate in this observational research study because you are an adult who has been identified as being treated with the drug FILSPARI (sparsentan), which has been approved for use by the Food and Drug Administration (FDA) to reduce levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN), and who are at risk of their disease progressing quickly.
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 you may experience while taking FILSPARI.
Your participation in this study will last approximately 2 years. You will be contacted every 3 months to collect study data including:
In addition, your doctor will be contacted every 3 months to identify or confirm potential liver-related problems and obtain any missing information that is needed.
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.
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