Effects of Ferric Citrate on Kidney Health in Children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of ferric citrate on intact FGF23 levels in pediatric patients aged 6-18 years with chronic kidney disease stages 3-4. It is a 12-month, double-blind, randomized, placebo-controlled trial involving 160 participants who will be assigned to receive either ferric citrate or a placebo. Blood samples will be collected at various intervals to assess the primary and safety outcomes. The study aims to evaluate both the efficacy and tolerability of ferric citrate in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Ages 6 to 18 years (inclusive);
2. 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
3. Serum phosphate \<=5.9 mg/dl;
4. Serum ferritin \<500 ng/ml and TSAT \<50%;
5. 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;
6. Able to swallow tablets;
7. Able to eat at least two meals a day;
8. In the opinion of the investigator, willing and able to follow the study treatment regimen and comply with the site investigator's recommendations.

Exclusion Criteria:

1. Patients currently treated with phosphate binders.
2. History of allergy to all ingredients (including non-medical ingredients) in both products (i.e. investigational product and placebo)
3. Current intestinal malabsorption, documented in the medical record; disease, inflammatory bowel syndrome, and/or Crohn's Disease.
4. Anticipated initiation of dialysis or kidney transplantation within 6 months
5. Current or planned future systemic immunosuppressive therapy
6. Prior solid organ transplantation
7. Receipt of bone marrow transplant within two years of screening
8. Current pregnancy, lactation or female subjects who have reached menarche, unless using highly-effective contraception as outlined in section 7.1.1 of Protocol
9. Patients participating in other interventional study (observational study participation permitted)
10. Poor adherence to medical treatments in the opinion of the investigator
11. Cystinosis
12. Fanconi syndrome
13. Hemochromatosis or laboratory tests indicating possible hemochromatosis or other iron overload (primary or secondary) syndrome

Where it's running

• University of California, Los Angeles
  Los Angeles, California, United States Recruiting
• Children's Hospital of Orange County
  Orange, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Arnold Palmer Hospital for Children
  Orlando, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Indiana U
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Isidro B Salusky, MD — University of California, Los Angeles
• Study coordinator: Jenny Brook, Ms
• Email: jbrook@mednet.ucla.edu
• Phone: 310-7943144

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.