Tests ferric citrate in children with chronic kidney disease
Compares ferric citrate with a placebo in children aged 6 to 18 with kidney disease.
Plain-language title generated from the registry record
Registry title: Ferric Citrate and Chronic Kidney Disease in Children
Key facts
- Where
- Toronto and Vancouver, CanadaSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 18 years old?
Source: NCT04741646, who can take part
Where in Canada
- SickKidsToronto, CanadaTaking people
- BC Children's Hospital Research InstituteVancouver, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of California, Los Angeles
- Trial code
- NCT04741646
- Record updated
- 17 April 2026
- Original description
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.Read full original descriptionShow less
Phosphate Binder Therapy and Chronic Kidney Disease in Children
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.
Inclusion: Ages 6 to 18 years (inclusive); Estimated Glomerular Filtration Rate (GFR) of 15-59 ml/min per 1.73 m2 by modified Chronic Kidney disease in Children (CKiD) under 25 (U25) formula;56; Serum phosphate <=5.9 mg/dl; Serum ferritin <500 ng/ml and TSAT <50%; For those patients treated with growth hormone, calcitriol, nutritional vitamin D, iron, and/or erythropoiesis-stimulating agents (ESAs) such treatments must have stable dosing for at least 2 weeks prior to screening; Able to swallow tablets; Able to eat at least two meals a day; In the opinion of the investigator, willing and able to follow the study treatment regimen and comply with the site investigator's recommendations.
Exclusion: Patients currently treated with phosphate binders; History of allergy to all ingredients (including non-medical ingredients) in both products (i.e. investigational product and placebo); Anticipated initiation of dialysis or kidney transplantation within 6 months; Current or planned future systemic immunosuppressive therapy; Prior solid organ transplantation; Receipt of bone marrow transplant within two years of screening; Current intestinal malabsorption, documented in the medical record; disease, inflammatory bowel syndrome, and/or Crohn's Disease; Fanconi syndrome; Hemochromatosis or laboratory tests indicating possible hemochromatosis or other iron overload (primary or secondary) syndrome; Current pregnancy, lactation or female subjects who have reached menarche, unless using highly-effective contraception as outlined in section 7.1.1 of Protocol; Patients participating in other interventional study (observational study participation permitted); Poor adherence to medical treatments in the opinion of the investigator; Cystinosis.