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EXACT Study: A Blinded Study in Patients With Alport Syndrome to Evaluate Exaluren Efficacy and Safety

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 12 to 11
    • Eligibility criteria expanded, about 9 words
  2. Site contacts updated at 1 of 12 sitesv4
  3. Recruitment opened
    • Site details revised at 12 of 12 sites
    v3
  4. Start date: May 30, 2026 to Jun 30, 2026
    • Trial sites expanded: 6 → 12 locations
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 randomized, double-Blind, placebo-controlled study to evaluate the efficacy and safety of exaluren in Alport Syndrome patients with nonsense mutations in COL4A3/4/5 genes. Targeted 24 patients aged 12 and older will be enrolled in the trial. The study will be comprised of the following periods for each participant: * a Screening period of up to 6 weeks (42 days) * a total Treatment Period of exaluren 0.75 mg/kg or placebo administered daily subcutaneously for 32 weeks: Part 1: patients are randomized to either exaluren or placebo for 16 weeks. Part 2: all patients across both randomized arms receive exaluren for 16 additional weeks. * a safety/efficacy Follow-up Period of 4 weeks after the last treatment
Trial Details
NCT Number NCT07523581
Lead Sponsor Eloxx Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Alport Syndrome, X-Linked, Alport Syndrome, Autosomal Recessive
Related terms Nephritis, Hereditary
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov