A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects With Selected Proteinuric Glomerular Diseases (EPPIK)

  • End date
    Jun 1, 2025
  • participants needed
  • sponsor
    Travere Therapeutics, Inc.
Updated on 11 October 2022
glomerular filtration rate
total protein
kidney biopsy


To evaluate the safety, efficacy and tolerability of sparsentan oral suspension and assess changes in proteinuria after once-daily dosing over the 108-week treatment period.


This is a multicenter, open-label, 112-week study of sparsentan in approximately 57 pediatric subjects aged ≥1 year to <18 years with selected proteinuric glomerular diseases, divided into 2 populations, defined as follows:

  • Population 1: Subjects with selected proteinuric glomerular diseases associated with Focal Segmental Glomerulosclerosis (FSGS) and Minimal Change Disease (MCD) histological patterns
  • Population 2: Subjects with kidney biopsy-confirmed immunoglobulin A nephropathy (IgAN), immunoglobulin A vasculitis (IgAV), or subjects with Alport syndrome (AS)

The study will evaluate long-term safety, tolerability, and efficacy with pharmacokinetic evaluations at Day 1 (Baseline), Day 2 (Visit 4), and Week 12 (Visit 9). For each population, subjects will be enrolled in 3 cohorts based on age ranges.

Study Enrollment:

  • Population 1: FSGS and/or MCD (30 subjects total)
    1. Cohort 1 (6 subjects): ≥8 years to <18 years
    2. Cohort 2 (18 subjects): ≥3 years to <8 years
    3. Cohort 3 (6 subjects): ≥1 year to <3 years
  • Population 2: IgAN, IgAV, or AS (27 subjects total)
    1. Cohort 1 (9 subjects): ≥8 years to <18 years
    2. Cohort 2 (12 subjects): ≥5 years to <8 years
    3. Cohort 3 (6 subjects): ≥2 years to <5 years

Condition Focal Segmental Glomerulosclerosis, Minimal Change Disease, Immunoglobulin A Nephropathy, IgA Vasculitis, Alport Syndrome
Treatment sparsentan
Clinical Study IdentifierNCT05003986
SponsorTravere Therapeutics, Inc.
Last Modified on11 October 2022


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