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Ferric Citrate and Chronic Kidney Disease in Children
About
Brief 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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- 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) formula;56
- Serum phosphate within age appropriate normal levels;
- 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 Criteria:
- 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; significant GI disorders including GI bleeding or active inflammatory bowel 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
- Hemochromatosis or laboratory tests indicating possible hemochromatosis or other iron overload (primary or secondary) syndrome
- Cystinosis
- Fanconi syndrome
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Study Stats
Protocol No.
22-001133
Category
Genitourinary Disorders
Pediatric and Prenatal Disorders
Principal Investigator
Contact
Location
- UCLA Westwood