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A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Feb 11, 2028 → May 21, 2029
See other at-risk trials from Kyowa Kirin Co., Ltd.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Feb 11, 2028 to May 21, 2029 Show 8 more changesShow less
    • Enrollment increased: 24 → 39 participants
    • Primary endpoints: details revised at 6 of 60 entries
    • Study completion pushed from May 10, 2028 to May 21, 2029
    • Trial arms changed: 5 → 6
    • Study sites: 9 to 10
    • Eligibility criteria expanded, about 126 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description shortened, about 3 words
  2. Study sites: 8 to 9
    • Eligibility criteria expanded, about 63 words
    v7
  3. Lead sponsor: Kyowa Kirin, Inc. to Kyowa Kirin Co., Ltd.
    • Collaborators expanded, about 3 words
    v6
  4. Study sites: 9 to 8v5
  5. Start date changed from estimate of Oct 7, 2024 to Oct 9, 2024v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 8 to 9v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 29, 2024 to Oct 7, 2024
    • Site details revised at 8 of 8 sites
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A first-in-human study of KK8123 in adults with X-linked hypophosphatemia.
Trial Details
NCT Number NCT06525636
Lead Sponsor Kyowa Kirin Co., Ltd.
Collaborators: Kyowa Kirin, Inc.
Conditions
(from sponsor)		 X-linked Hypophosphatemia
Related terms Bone Diseases, Familial Hypophosphatemic Rickets, Hypophosphatemia, Kidney Diseases, Metabolic Diseases, Musculoskeletal Diseases, Rare Diseases
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov