Clinical Trial

Ferric Citrate and Chronic Kidney Disease in Children

Study acronym: FIT4KID
Recruiting Phase 2
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Summary
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-02-02; most recent amendment 2026-04-14.
Status change: Not Yet Recruiting → Recruiting 2022-09-01
Trial Details
NCT Number NCT04741646
Lead Sponsor University of California, Los Angeles
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Chronic Kidney Diseases
Enrollment 160 participants
Start Date 2022-06-17
Primary Completion 2027-10 (estimated)
Study Completion 2028-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-17