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Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 34 → 38 locationsv11
  2. Trial sites expanded: 29 → 34 locationsv10
  3. Re-verified, no change to tracked fieldsv9
  4. Trial sites expanded: 25 → 29 locationsv8
  5. Primary completion pushed from Jul 2027 to Dec 31, 2028 Trial sites expanded: 12 → 25 locations · Completion pushed from Jul 2028 to Jun 2029v7 Show 2 more changesShow less
    • Trial sites expanded: 12 → 25 locations
    • Completion pushed from Jul 2028 to Jun 2029
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  1. Eligibility criteria shortened, about 2 wordsv6 See this version in full on ClinicalTrials.gov ↗
  2. Eligibility criteria shortened, about 14 wordsv5 See this version in full on ClinicalTrials.gov ↗
  3. Interventions: ADX-038 (Drug) to ADX-038 Dose Level 1 (Drug), ADX-038 Dose Level 2 (Drug) Site details revised at 1 of 12 sites · Study arms: 2 to 3v4 Show 2 more changesShow less
    • Site details revised at 1 of 12 sites
    • Study arms: 2 to 3
  4. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 30 to 45 · Study sites: 0 to 12 · Start date changed from estimate of Jul 2025 to Aug 28, 2025v3 Show 3 more changesShow less
    • Enrollment target: 30 to 45
    • Study sites: 0 to 12
    • Start date changed from estimate of Jul 2025 to Aug 28, 2025
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.
Trial Details
NCT Number NCT06989359
Lead Sponsor ADARx Pharmaceuticals, Inc.
Conditions IgAN, C3G, Complement-mediated Kidney Disease, IgA Nephropathy (IgAN), IC-MPGN
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov