A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome

Study acronym: INShore
StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Primary endpoint(s) modified Show 8 more changesShow less
    • Results posted: Oct 14, 2026
    • Trial completed
    • Trial sites reduced: 39 → 35 locations
    • Study completion date changed from estimate of Sep 4, 2026 to Aug 27, 2026
    • Interventions: Acetaminophen/ Paracetamol (Drug), Diphenhydramine Hydrochloride (Drug), MMF (Drug), Methylprednisolone (Drug), Obinutuzumab (Drug)… to Acetaminophen/ Paracetamol (Drug), Diphenhydramine Hydrochloride (Drug), MMF (Drug), Methylprednisolone (Drug), Obinutuzumab (Drug)…
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: 13 to 16
    • Publications: details revised at 2 of 2 entries
  2. Study sites: 55 to 39v27
  3. Enrollment target: estimated 80 to confirmed 85
    • Primary completion date changed from estimate of Sep 15, 2025 to Sep 4, 2025
    • Study completion date: Sep 15, 2026 to Sep 4, 2026
    v26
  4. Study sites: 58 to 55v25
  5. Primary completion date: Aug 15, 2026 to Sep 15, 2025
    • Study completion date: Aug 15, 2026 to Sep 15, 2026
    • Site details revised at 3 of 58 sites
    v24
Show 22 earlier versionsHide 22 earlier versions
  1. Study sites: 55 to 58v23
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 59 to 55
    v22
  3. Study sites: 58 to 59v21
  4. Re-verified, no change to tracked fieldsv20
  5. Study sites: 57 to 58v19
  6. Study sites: 56 to 57v18
  7. Study sites: 54 to 56v17
  8. Study sites: 48 to 54v16
  9. Study sites: 46 to 48v15
  10. Study sites: 45 to 46v14
  11. Study sites: 44 to 45v13
  12. Study sites: 42 to 44v12
  13. Study sites: 39 to 42v11
  14. Study sites: 32 to 39v10
  15. Study sites: 20 to 32v9
  16. Study sites: 18 to 20
    • Secondary endpoints revised (13)
    v8
  17. Re-verified, no change to tracked fieldsv7
  18. Primary completion date: Dec 1, 2025 to Aug 15, 2026
    • Study sites: 13 to 18
    • Secondary endpoints revised (13)
    v6
  19. Study sites: 9 to 13v5
  20. Study sites: 3 to 9
    • Start date changed from estimate of Feb 28, 2023 to Mar 29, 2023
    v4
  21. Study sites: 2 to 3v3
  22. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    v2
  1. Study First Submitted
  • 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
367 trials monitored
See 31 trials at risk
This open-label, randomized multicenter study is to assess the efficacy, safety, and pharmacokinetics (PK)/pharmacodynamics (PD) of obinutuzumab compared with mycophenolate mofetil (MMF) in children and young adults (aged \>= 2-25 years) with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS).
Trial Details
NCT Number NCT05627557
Lead Sponsor Hoffmann-La Roche
Conditions
(from sponsor)		 Childhood Idiopathic Nephrotic Syndrome
Related terms Nephrotic Syndrome
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov