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Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1-Mediated Proteinuric Kidney Disease

Study acronym: AMPLITUDE
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 98 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 8 words Study sites revised (318) Show 1 more changeShow less
    • Study sites revised (318)
  2. Site details revised at 27 of 318 sitesv97
  3. Site details revised at 1 of 318 sitesv96
  4. Site details revised at 2 of 318 sitesv95
  5. Site details revised at 8 of 318 sitesv94
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 1 of 318 sitesv93
  2. Site details revised at 1 of 318 sitesv92
  3. Site details revised at 2 of 318 sitesv91
  4. Primary completion date: May 31, 2026 to Jun 2, 2028 Completion date: Jun 30, 2026 to May 7, 2030 · Eligibility criteria expanded, about 51 words · Secondary endpoints: 6 to 7 · 2 morev90 Show 5 more changesShow less
    • Completion date: Jun 30, 2026 to May 7, 2030
    • Eligibility criteria expanded, about 51 words
    • Secondary endpoints: 6 to 7
    • Site details revised at 1 of 318 sites
    • Study arms: 4 to 3

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 1 of 318 sitesv89
  6. Site details revised at 3 of 318 sitesv88
  7. Site details revised at 1 of 318 sitesv87
  8. Site details revised at 4 of 318 sitesv86
  9. Study sites: 316 to 318v85
  10. Study sites: 314 to 316v84
  11. Site details revised at 2 of 314 sitesv83
  12. Site details revised at 1 of 314 sitesv82
  13. Site details revised at 2 of 314 sitesv81
  14. Study sites: 312 to 314v80
  15. Study sites: 315 to 312v79
  16. Re-verified, no change to tracked fieldsv78
  17. Study sites revised (315)v77 See this version in full on ClinicalTrials.gov ↗
  18. Study sites: 314 to 315v76
  19. Study sites: 313 to 314v75
  20. Study sites: 311 to 313v74
  21. Study sites: 304 to 311 Eligibility criteria revisedv73 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  22. Phase: Phase 3 to Phase 2/3 Eligibility criteria revised · Secondary endpoints: 5 to 6 · Study title expanded, about 4 wordsv72 Show 3 more changesShow less
    • Eligibility criteria revised
    • Secondary endpoints: 5 to 6
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  23. Study sites: 301 to 304v71
  24. Phase: Phase 2/3 to Phase 3 Study sites: 300 to 301 · Primary completion date: May 2026 to May 31, 2026 · Completion date: Jun 2026 to Jun 30, 2026 · 1 morev70 Show 4 more changesShow less
    • Study sites: 300 to 301
    • Primary completion date: May 2026 to May 31, 2026
    • Completion date: Jun 2026 to Jun 30, 2026
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  25. Study sites: 296 to 300v69
  26. Study sites: 293 to 296v68
  27. Study sites: 292 to 293v67
  28. Re-verified, no change to tracked fieldsv66
  29. Study sites: 289 to 292v65
  30. Study sites: 281 to 289v64
  31. Study sites: 279 to 281v63
  32. Study sites: 278 to 279v62
  33. Study sites: 271 to 278v61
  34. Study sites: 269 to 271v60
  35. Study sites: 266 to 269v59
  36. Study sites: 258 to 266v58
  37. Study sites: 257 to 258v57
  38. Study sites: 248 to 257v56
  39. Study sites: 243 to 248v55
  40. Study sites: 241 to 243v54
  41. Study sites: 239 to 241v53
  42. Study sites: 236 to 239v52
  43. Study Identification, Study Statusv51
  44. Site details revised at 1 of 236 sitesv50
  45. Site details revised at 3 of 236 sitesv49
  • 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.
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.
Trial Details
NCT Number NCT05312879
Lead Sponsor Vertex Pharmaceuticals Incorporated
Conditions Proteinuric Kidney Disease
Enrollment 466 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov