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)
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- STATUS
- Recruiting
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- End date
- Jun 1, 2025
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- participants needed
- 57
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- sponsor
- Travere Therapeutics, Inc.
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)
- Cohort 1 (6 subjects): ≥8 years to <18 years
- Cohort 2 (18 subjects): ≥3 years to <8 years
- Cohort 3 (6 subjects): ≥1 year to <3 years
- Population 2: IgAN, IgAV, or AS (27 subjects total)
- Cohort 1 (9 subjects): ≥8 years to <18 years
- Cohort 2 (12 subjects): ≥5 years to <8 years
- 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 Identifier | NCT05003986 |
| Sponsor | Travere Therapeutics, Inc. |
| Last Modified on | 11 October 2022 |
Eligibility
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