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NCT06963827

A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy

StatusRecruiting
PhasePhase 3
SponsorTakeda
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 49 versions: 48 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 179 → 186 locations
  2. Study sites: 179 to 181
  3. Study sites: 177 to 179
  4. Eligibility criteria expanded, about 22 words
    • Study sites: 176 to 177
    • Secondary endpoints: details revised at 1 of 5 entries
    • Publications: details revised at 1 of 1 entry
  5. Study sites: 175 to 176v45
  6. Trial sites expanded: 172 → 175 locationsv44
  7. Study sites: 171 to 172
    • Secondary endpoints revised (5)
    v43
  8. Study sites: 170 to 171v42
  9. Study sites: 169 to 170v41
  10. Trial sites expanded: 166 → 169 locationsv40
  11. Trial sites expanded: 163 → 166 locationsv39
  12. Trial sites expanded: 158 → 163 locationsv38
  13. Trial sites expanded: 154 → 158 locationsv37
  14. Study sites: 153 to 154v36
  15. Eligibility criteria expanded, about 145 words
    • Secondary endpoints: 8 to 5
    • Study title revised
    v35
  16. Study sites: 152 to 153v34
  17. Trial sites expanded: 147 → 152 locationsv33
  18. Trial sites expanded: 144 → 147 locationsv32
  19. Study sites: 142 to 144v31
  20. Study sites: 140 to 142v30
  21. Trial sites expanded: 137 → 140 locationsv29
  22. Trial sites expanded: 133 → 137 locationsv28
  23. Study sites: 128 to 133v27
  24. Study sites: 122 to 128v26
  25. Study sites: 115 to 122v25
  26. Study sites: 105 to 115v24
  27. Study sites: 94 to 105v23
  28. Study sites: 90 to 94v22
  29. Study sites: 86 to 90v21
  30. Study sites: 83 to 86v20
  31. Study sites: 69 to 83v19
  32. Study sites: 61 to 69v18
  33. Study sites: 54 to 61v17
  34. Study sites: 51 to 54v16
  35. Study sites: 49 to 51v15
  36. Study sites: 47 to 49v14
  37. Study sites: 43 to 47v13
  38. Study sites: 40 to 43v12
  39. Study sites: 33 to 40v11
  40. Study sites: 29 to 33v10
  41. Study sites: 27 to 29v9
  42. Study sites: 22 to 27v8
  43. Study sites: 15 to 22v7
  44. Study sites: 14 to 15v6
  45. Study sites: 13 to 14v5
  46. Study sites: 7 to 13v4
  47. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 7
    • Start date changed from estimate of Aug 15, 2025 to Jul 15, 2025
    v3
  48. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change from Baseline in Proteinuria at Week 36
Timeframe: From Baseline to Week 36

Secondary (5)

Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 and 104, Respectively
The Rate of Change in eGFR From Baseline at Week 104
Time From Baseline to the First Occurrence of Sustained Decline in eGFR of ≥30 Percent (%) From Baseline Over at Least 4 Weeks
Time from Baseline to the First Occurrence of Any of the Pre-specified Kidney Failure Composite Assessment Criteria
Percentage of Participants Who Achieve ≥30% Reduction From Baseline in Proteinuria at Week 104

Arms and interventions

MezagitamabExperimental

Participants will receive mezagitamab injections, subcutaneously (SC), for approximately 22 weeks.

PlaceboPlacebo comparator

Participants will receive mezagitamab-matching placebo injections, SC for approximately 22 weeks.

Open-label MezagitamabExperimental

Participants will receive mezagitamab injections, SC for approximately 22 weeks.

Drugs: Mezagitamab, Placebo

Sites

186 sites in 26 countries

United States 45, China 21, Japan 20, United Kingdom 10, Italy 8, Spain 8, Turkey (Türkiye) 7, France 6, Malaysia 6, Norway 6, South Korea 6, Australia 5, Netherlands 5, Taiwan 5, Argentina 4, Poland 4, Canada 3, Czechia 3, Germany 3, Singapore 3, Austria 2, Slovenia 2, Hong Kong 1, Hungary 1, Sweden 1, Switzerland 1