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Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1

Study acronym: CALIBRATE
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Site details revised at 1 of 25 sitesv14
  2. Site details revised at 1 of 25 sitesv13
  3. Primary completion date changed from estimate of Aug 2025 to Aug 22, 2025
    • Study completion date: Sep 2028 to Aug 2029
    • Site details revised at 1 of 25 sites
    v12
  4. Study description shortened, about 270 words
    • Site details revised at 1 of 25 sites
    v11
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 60 to confirmed 67
    • Study sites: 30 to 25
    • Primary completion date: Apr 2025 to Aug 2025
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 27 to 30v9
  2. Primary completion date: Jun 2024 to Apr 2025
    • Study sites: 21 to 27
    • Eligibility criteria expanded, about 4 words
    v8
  3. Study sites: 14 to 21
    • Eligibility criteria expanded, about 27 words
    • Study description expanded, about 14 words
    v7
  4. Study sites: 9 to 14v6
  5. Primary endpoint revisedv5 Show 6 more changesShow less
    • Primary completion date: Dec 15, 2023 to Jun 2024
    • Study completion date: Dec 15, 2028 to Sep 2028
    • Interventions: Calcium supplements and active Vitamin D (calcitriol, alfacalcidol, falecalcitriol, etc.) (Dietary Supplement), Encaleret (Drug) to Encaleret (Drug), Standard of Care (Dietary Supplement)
    • Eligibility criteria shortened, about 271 words
    • Secondary endpoints: 2 to 13
    • Study description shortened, about 128 words
  6. Study sites: 3 to 9v4
  7. Primary endpoint revisedv3 Show 5 more changesShow less
    • Enrollment target: 45 to 60
    • Study sites: 2 to 3
    • Eligibility criteria shortened, about 43 words
    • Secondary endpoints: 10 to 2
    • Study description revised
  8. Study sites: 1 to 2v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary purpose of the study is to understand the effectiveness, safety, and tolerability of encaleret when compared to standard of care (SoC) treatment in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1).
Trial Details
NCT Number NCT05680818
Lead Sponsor Calcilytix Therapeutics, Inc., a BridgeBio company
Conditions
(from sponsor)		 Autosomal Dominant Hypocalcemia (ADH)
Related terms Calcium Metabolism Disorders, Hypercalciuria, Hypercalciuric Hypocalcemia, Familial, Hypocalcemia, Hypoparathyroidism, Metabolic Diseases, Muscular Diseases, Musculoskeletal Abnormalities, Musculoskeletal Diseases, Nephrocalcinosis, Nephrolithiasis
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov