Ferric Citrate and Chronic Kidney Disease in Children

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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)
• Current intestinal malabsorption, documented in the medical record; disease, inflammatory bowel syndrome, and/or Crohn's Disease.
• 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 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
• Fanconi syndrome
• Hemochromatosis or laboratory tests indicating possible hemochromatosis or other iron overload (primary or secondary) syndrome

Where this trial is running

• University of California, Los Angeles, Los Angeles, California, United States
• Children's Hospital of Orange County, Orange, California, United States
• University of California, San Francisco, San Francisco, California, United States
• Arnold Palmer Hospital for Children, Orlando, Florida, United States
• Emory University, Atlanta, Georgia, United States
• Indiana U, Indianapolis, Indiana, United States
• Children's Mercy Hospital, Kansas City, Kansas City, Missouri, United States
• Washington U, St Louis, Missouri, United States
• Cohen's Childrens, New York, New York, United States
• Children's Hospital at Montefiore, The Bronx, New York, United States
• Duke, Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

+ 8 more sites.

Who to contact

JENNY BROOK, MS · 310-7943144 · jbrook@mednet.ucla.edu

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04741646.