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A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

Study acronym: IMAGINATION
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 8 months later Aug 31, 2026 → May 25, 2028
See other at-risk trials from Roche/Genentech

Record History

  1. Primary completion pushed from Aug 31, 2026 to May 25, 2028 Trial sites reduced: 178 → 171 locations · Completion pushed from Mar 31, 2029 to Aug 31, 2029 · Eligibility criteria expanded, about 29 words · 2 more Show 5 more changesShow less
    • Trial sites reduced: 178 → 171 locations
    • Completion pushed from Mar 31, 2029 to Aug 31, 2029
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 2 of 6 entries
    • Publications: 2 to 3
  2. Enrollment closed, study ongoing Trial sites reduced: 204 → 178 locations · Enrollment target: estimated 428 to confirmed 459v41 Show 2 more changesShow less
    • Trial sites reduced: 204 → 178 locations
    • Enrollment target: estimated 428 to confirmed 459
  3. Secondary endpoints: 5 to 6 Study sites revised (204) · Eligibility criteria expanded, about 3 wordsv40 Show 2 more changesShow less
    • Study sites revised (204)
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 202 to 204v39
  5. Study sites: 200 to 202v38
Show 36 earlier versionsHide 36 earlier versions
  1. Study sites: 199 to 200v37
  2. Study sites: 198 to 199v36
  3. Study sites: 197 to 198v35
  4. Study sites: 196 to 197v34
  5. Study sites: 193 to 196v33
  6. Study sites: 188 to 193v32
  7. Study sites: 187 to 188v31
  8. Study sites: 183 to 187 Interventions: Placebo (Drug), sefaxersen (RO7434656) (Drug) to Placebo (Drug), Sefaxersen (RO7434656) (Drug) · Eligibility criteria expanded, about 10 words · Secondary endpoints revised (5)v30 Show 3 more changesShow less
    • Interventions: Placebo (Drug), sefaxersen (RO7434656) (Drug) to Placebo (Drug), Sefaxersen (RO7434656) (Drug)
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (5)

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 181 to 183v29
  10. Study sites: 177 to 181 Primary completion date: Jul 31, 2026 to Aug 31, 2026 · Completion date: Sep 30, 2030 to Mar 31, 2029v28 Show 2 more changesShow less
    • Primary completion date: Jul 31, 2026 to Aug 31, 2026
    • Completion date: Sep 30, 2030 to Mar 31, 2029
  11. Study sites: 175 to 177v27
  12. Study sites: 171 to 175v26
  13. Study sites: 170 to 171v25
  14. Primary completion date: Sep 30, 2026 to Jul 31, 2026 Interventions: Placebo (Drug), RO7434656 (Drug) to Placebo (Drug), sefaxersen (RO7434656) (Drug) · Eligibility criteria expanded, about 152 words · Secondary endpoints revised (5) · 2 morev24 Show 5 more changesShow less
    • Interventions: Placebo (Drug), RO7434656 (Drug) to Placebo (Drug), sefaxersen (RO7434656) (Drug)
    • Eligibility criteria expanded, about 152 words
    • Secondary endpoints revised (5)
    • Study sites revised (170)
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 167 to 170v23
  16. Re-verified, no change to tracked fieldsv22
  17. Study sites: 166 to 167v21
  18. Study sites: 160 to 166v20
  19. Study sites: 151 to 160v19
  20. Study sites: 137 to 151v18
  21. Study sites: 117 to 137v17
  22. Study sites: 99 to 117v16
  23. Study sites: 78 to 99v15
  24. Study sites: 62 to 78v14
  25. Study sites: 26 to 62v13
  26. Study sites: 21 to 26v12
  27. Study sites: 18 to 21 Eligibility criteria expanded, about 10 words · Secondary endpoints: 6 to 5v11 Show 2 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: 6 to 5

    See this version in full on ClinicalTrials.gov ↗

  28. Study sites: 13 to 18v10
  29. Study sites: 11 to 13v9
  30. Study sites: 9 to 11v8
  31. Study sites: 8 to 9v7
  32. Study sites: 5 to 8 Start date changed from estimate of Aug 31, 2023 to Aug 8, 2023v6 Show 1 more changeShow less
    • Start date changed from estimate of Aug 31, 2023 to Aug 8, 2023
  33. Start date: Jun 30, 2023 to Aug 31, 2023 Study sites: 4 to 5v5 Show 1 more changeShow less
    • Study sites: 4 to 5
  34. Study sites: 2 to 4v4
  35. Trial status: Not Yet Recruiting to Recruiting Start date: Apr 28, 2023 to Jun 30, 2023 · Study sites: 0 to 2v3 Show 2 more changesShow less
    • Start date: Apr 28, 2023 to Jun 30, 2023
    • Study sites: 0 to 2
  36. Re-verified, no change to tracked fieldsv2
  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.
Roche/Genentech
366 trials monitored
See 33 trials at risk
The purpose of this study is to evaluate the efficacy, safety, \& pharmacokinetics of sefaxersen (RO7434656), a novel Antisense Oligonucleotide (ASO) therapy in participants with primary IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite optimized supportive care.
Trial Details
NCT Number NCT05797610
Lead Sponsor Hoffmann-La Roche
Conditions Primary IgA Nephropathy
Enrollment 459 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov