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A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

Study acronym: PROTECT
StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 1 entry Show 5 more changesShow less
    • Trial completed
    • Study completion date changed from estimate of Jul 2026 to Aug 19, 2026
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Publications: details revised at 5 of 5 entries
  2. 2 versions Re-verified since Jun 6, 2025, no change to tracked fieldsv20-v21
  3. Site details revised at 1 of 162 sitesv19
  4. Results first posted: Jul 3, 2024
    • Primary endpoint revised
    • Enrollment target: estimated 380 to confirmed 406
    • Secondary endpoints: 3 to 2
    v18
  5. Primary completion date changed from estimate of Aug 2023 to Aug 7, 2023v17
Show 15 earlier versionsHide 15 earlier versions
  1. Study sites: 161 to 162v16
  2. Interventions: irbesartan (Drug), sparsentan (Drug) to Dapagliflozin (Drug), irbesartan (Drug), sparsentan (Drug)v15 Show 4 more changesShow less
    • Eligibility criteria expanded, about 108 words
    • Study description expanded, about 111 words
    • Site details revised at 3 of 161 sites
    • Study arms: 2 to 4
  3. Start date: Dec 20, 2018 to Dec 11, 2018
    • Site details revised at 7 of 161 sites
    v14
  4. Primary completion date: Mar 2023 to Aug 2023
    • Study completion date: Apr 2023 to Jul 2026
    • Study description expanded, about 31 words
    v13
  5. Study sites: 168 to 161v12
  6. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 164 to 168
    • Secondary endpoints: 4 to 3
    v11
  7. Study sites: 156 to 164v10
  8. Study sites revised (156)v9
  9. Enrollment target: 280 to 380v8 Show 4 more changesShow less
    • Study sites: 150 to 156
    • Eligibility criteria expanded, about 121 words
    • Secondary endpoints: 3 to 4
    • Study description expanded, about 78 words
  10. Study sites: 130 to 150v7
  11. Study sites: 99 to 130v6
  12. Study sites: 66 to 99v5
  13. Study sites: 51 to 66v4
  14. Study sites: 10 to 51v3
  15. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 10
    • Start date changed from estimate of Dec 2018 to Dec 20, 2018
    v2
  1. 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 determine the long-term (approximately 2 years) nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with immunoglobulin A nephropathy (IgAN).
Trial Details
NCT Number NCT03762850
Lead Sponsor Travere Therapeutics, Inc.
Conditions
(from sponsor)		 Immunoglobulin A Nephropathy
Related terms Glomerulonephritis, IGA
Enrollment 406 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov