Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05485961 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)

Study acronym: POSIBIL6ESKD
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Oct 21, 2022 to Apr 27, 2024 Trial sites expanded: 557 → 566 locations · Eligibility criteria expanded, about 11 words · Secondary endpoints: details revised at 1 of 38 entries · 1 more Show 4 more changesShow less
    • Trial sites expanded: 557 → 566 locations
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 38 entries
    • Publications: details revised at 1 of 1 entry
  2. Trial sites expanded: 548 → 557 locationsv42
  3. Study sites: 547 to 548 Eligibility criteria expanded, about 42 words · Secondary endpoints: details revised at 29 of 38 entriesv41 Show 2 more changesShow less
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints: details revised at 29 of 38 entries

    See this version in full on ClinicalTrials.gov ↗

  4. Trial sites expanded: 542 → 547 locationsv40
  5. Enrollment increased: 2310 → 3110 participants Eligibility criteria shortened, about 9 words · Study title expanded, about 1 wordv39 Show 2 more changesShow less
    • Eligibility criteria shortened, about 9 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Trial sites expanded: 538 → 542 locations Primary and study completion moved earlier from Sep 27, 2029 to May 22, 2029v38 Show 1 more changeShow less
    • Primary and study completion moved earlier from Sep 27, 2029 to May 22, 2029
  7. Trial sites expanded: 468 → 538 locationsv37
  8. Study sites: 413 to 468 Primary and study completion dates: Aug 30, 2029 to Sep 27, 2029v36 Show 1 more changeShow less
    • Primary and study completion dates: Aug 30, 2029 to Sep 27, 2029
  9. Re-verified, no change to tracked fieldsv35
  10. Study sites: 362 to 413 Interventions: CSL300 (Drug), Placebo (Drug), Placebo (Drug) to CSL300 (Drug), Placebo (Drug) · Eligibility criteria expanded, about 9 wordsv34 Show 2 more changesShow less
    • Interventions: CSL300 (Drug), Placebo (Drug), Placebo (Drug) to CSL300 (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 346 to 362v33
  12. Study sites: 345 to 346v32
  13. Study sites: 304 to 345v31
  14. Study sites: 279 to 304v30
  15. Site contacts updated at 3 of 279 sitesv29
  16. Study sites: 254 to 279v28
  17. Study sites: 234 to 254v27
  18. Study sites: 226 to 234v26
  19. Study sites: 201 to 226v25
  20. Primary and study completion dates: Dec 2028 to Aug 30, 2029 Primary endpoints revised (2) · Eligibility criteria expanded, about 12 words · Secondary endpoints: 37 to 38v24 Show 3 more changesShow less
    • Primary endpoints revised (2)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: 37 to 38

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites: 186 to 201v23
  22. Study sites: 164 to 186v22
  23. Re-verified, no change to tracked fieldsv21
  24. Study sites: 161 to 164v20
  25. Study sites: 120 to 161v19
  26. Study sites: 121 to 120v18
  27. Study sites: 93 to 121v17
  28. Study sites: 70 to 93v16
  29. Trial status: Enrolling by Invitation to Recruiting Site details revised at 70 of 70 sitesv15 Show 1 more changeShow less
    • Site details revised at 70 of 70 sites
  30. Study sites: 60 to 70v14
  31. Re-verified, no change to tracked fieldsv13
  32. Trial status: Active, Not Recruiting to Enrolling by Invitationv12
  33. 3 versions Re-verified since Mar 27, 2024, no change to tracked fieldsv9-v11
  34. Study sites: 20 to 60v8
  35. Trial status: Recruiting to Active, Not Recruiting Study sites: 1 to 20v7 Show 1 more changeShow less
    • Study sites: 1 to 20
  36. 2 versions Re-verified since Oct 26, 2023, no change to tracked fieldsv5-v6
  37. Interventions: CSL300 (Drug), Placebo (Drug) to CSL300 (Drug), Placebo (Drug), Placebo (Drug)v4
  38. Re-verified, no change to tracked fieldsv3
  39. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Sep 2022 to Oct 21, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2022 to Oct 21, 2022
  40. 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.
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo. Part 2: Phase 3 aims to assess the efficacy of CSL300 vs placebo on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.
Trial Details
NCT Number NCT05485961
Lead Sponsor CSL Behring
Conditions End Stage Kidney Disease
Enrollment 3,110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov