NCT05003986 · Travere Therapeutics, Inc.
Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases
(EPPIK)
What this study is about
To evaluate the safety, effectiveness and tolerability of sparsentan taken by mouth suspension and tablets, and assess changes in proteinuria after once-daily dosing over 108 weeks.
View original scientific description
To evaluate the safety, efficacy and tolerability of sparsentan oral suspension and tablets, and assess changes in proteinuria after once-daily dosing over 108 weeks.
Interventions
DRUG
Sparsentan
Population 1: 800 mg Sparsentan (oral suspension)
DRUG
Sparsentan
Population 2: 400 mg Sparsentan (oral suspension)
DRUG
Sparsentan
Population 3: 400 mg Sparsentan (tablets)
Primary outcome measures
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of interest (AEOIs)
Time frame: After the last patient has undergone the week 108 visit (Visit 15).
The incidence of TEAEs, SAEs, AEs leading to treatment discontinuation, and AEOIs
Urine protein/creatinine ratio (UP/C) at week 108
Time frame: After the last patient has undergone the Week 108 visit (Visit 15)
Change from baseline in UP/C over 108 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for All Subjects (All Three Populations): A subject must meet all of the following criteria to be eligible for participation in this study:
- The subject or parent/legal guardian (as appropriate) is willing and able to provide signed informed consent/assent, and where required, the subject is willing to provide assent before any screening procedures per local requirements.
- The subject has an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening.
- The subject has a mean seated blood pressure between the 5th and 95th percentile for sex and height. Inclusion Criteria for Population 1:
- The subject is male or female ≥1 year at screening and \<18 years of age at Day 1 (Baseline).
- The subject has a UP/C ≥1.5 g/g (170 mg/mmol) at screening AND one of the following:
- Kidney biopsy-proven FSGS or MCD histological patterns and clinical presentation consistent with primary FSGS or MCD and qualifying proteinuria at screening despite history or on
Where
- Los Angeles, California
- Wilmington, Delaware
- Miami, Florida
- Iowa City, Iowa
- Boston, Massachusetts
- Ann Arbor, Michigan
- Minneapolis, Minnesota
- Kansas City, Missouri
- Hackensack, New Jersey
- Neptune City, New Jersey
- New Hyde Park, New York
- New York, New York
And 8 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 12, 2026 · Source of record for eligibility and locations