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)

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    57
  • sponsor
    Travere Therapeutics, Inc.
Updated on 20 August 2022
corticosteroids
glomerular filtration rate
total protein
proteinuria
mammogram
kidney biopsy

Summary

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.

Description

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

Details
Condition Focal Segmental Glomerulosclerosis, Minimal Change Disease, Immunoglobulin A Nephropathy, IgA Vasculitis, Alport Syndrome
Treatment sparsentan
Clinical Study IdentifierNCT05003986
SponsorTravere Therapeutics, Inc.
Last Modified on20 August 2022

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