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Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases

Study acronym: EPPIK
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Site details revised at 1 of 47 sitesv28
  2. Minor Study sites: 46 to 47v27
  3. Minor Site details revised at 3 of 46 sitesv26
  4. Notable Primary completion date: May 1, 2025 to Mar 12, 2027
    • Study completion date: Jun 1, 2025 to Apr 12, 2027
    • Study description expanded, about 1 word
    v25
  5. Minor Site details revised at 1 of 46 sitesv24
Show 22 earlier versionsHide 22 earlier versions
  1. Minor Site details revised at 4 of 46 sitesv23
  2. Minor Study sites: 42 to 46v22
  3. Minor Enrollment target: 57 to 67v21 Show 6 more changesShow less
    • Study sites: 41 to 42
    • Interventions: Sparsentan (Drug), Sparsentan (Drug) to Sparsentan (Drug), Sparsentan (Drug), Sparsentan (Drug)
    • Eligibility criteria expanded, about 79 words
    • Secondary endpoints: 8 to 9
    • Study description expanded, about 64 words
    • Study arms: 2 to 3
  4. Minor Study sites: 38 to 41v20
  5. Minor Study sites: 35 to 38v19
  6. Minor Study sites: 33 to 35v18
  7. Minor Site details revised at 2 of 33 sitesv17
  8. Minor Study sites: 32 to 33v16
  9. Minor Study sites: 29 to 32v15
  10. Minor Study sites: 26 to 29v14
  11. Minor Eligibility criteria expanded, about 34 words
    • Secondary endpoints: 7 to 8
    • Study description expanded, about 74 words
    v13
  12. Minor Study sites: 25 to 26v12
  13. Minor Study sites: 24 to 25v11
  14. Minor Study sites: 23 to 24v10
  15. Minor Re-verified, no change to tracked fieldsv9
  16. Minor Study sites: 18 to 23v8
  17. Minor Study sites: 11 to 18v7
  18. Minor Study sites: 6 to 11v6
  19. Minor Study sites: 5 to 6v5
  20. Minor Study sites: 3 to 5v4
  21. Minor Site details revised at 1 of 3 sitesv3
  22. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 3
    • Start date changed from estimate of Aug 31, 2021 to Aug 12, 2021
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05003986
Lead Sponsor Travere Therapeutics, Inc.
Conditions
(from sponsor)
Focal Segmental Glomerulosclerosis, Minimal Change Disease, Immunoglobulin A Nephropathy, IgA Vasculitis, Alport Syndrome
Related terms Glomerulonephritis, IGA, Glomerulosclerosis, Focal Segmental, IgA Vasculitis, Macular dystrophy, corneal type 1, Nephritis, Hereditary, Nephrosis, Lipoid
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov