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Ferric Citrate and Chronic Kidney Disease in Children

Study acronym: FIT4KID
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study completion date: Oct 2027 to Nov 30, 2028v7
  2. Primary and study completion dates: Dec 1, 2025 to Oct 2027v6 Show 5 more changesShow less
    • Start date: May 16, 2022 to Jun 17, 2022
    • Study sites: 21 to 20
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints: 11 to 2
    • Study description shortened, about 6 words
  3. Study sites: 12 to 21
    • Secondary endpoints: 5 to 11
    • Study description shortened, about 1 word
    v5
  4. Study sites: 11 to 12
    • Eligibility criteria expanded, about 80 words
    • Secondary endpoints revised (5)
    • Study description shortened, about 2 words
    v4
  5. Site details revised at 8 of 11 sites
    • Study description expanded, about 3 words
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Dec 1, 2024 to Dec 1, 2025
    • Start date changed from estimate of Apr 1, 2021 to May 16, 2022
    • Study sites revised (11)
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
We will conduct a 12-month, double-blind, randomized, placebo-controlled trial to assess the effects of therapy with ferric citrate (FC) on changes in intact FGF23 levels (iFGF23, primary endpoint) in 160 pediatric patients (80 in each of the two arms) aged 6-18 years of either sex with chronic kidney disease (CKD) stages 3-4 and age-appropriate normal serum phosphate levels. Participants will be randomized to one of the two groups: 1) FC or 2) FC placebo. Participants will be recruited from 20 core clinical sites.
Trial Details
NCT Number NCT04741646
Lead Sponsor University of California, Los Angeles
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Chronic Kidney Diseases
Related terms Renal Insufficiency, Chronic
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov