Ferric Citrate: Auryxia® 210 mg ferric iron tablets equivalent to 1 g of FC will be supplied as 200 tablets in 400cc high-density polyethylene bottles.
Placebo: Placebo to match Ferric Citrate tablets
Study 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.
Eligibility
Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
No
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
Primary outcome measure(s)
iFGF23 levels — 12 months Compared to placebo, active treatment with FC will lower iFGF23 levels
Safety of Ferric Citrate — 12 months Comparing proportion of subjects with AE and SAE between arms
Tolerability of Ferric Citrate — 12 months Compared with placebo, active treatment will be tolerable
Trial sites (20)
Facility
City
Region
Status
University of California, Los Angeles
Los Angeles
California
Recruiting
Children's Hospital of Orange County
Orange
California
Recruiting
University of California, San Francisco
San Francisco
California
Recruiting
Arnold Palmer Hospital for Children
Orlando
Florida
Recruiting
Emory University
Atlanta
Georgia
Recruiting
Indiana U
Indianapolis
Indiana
Recruiting
Children's Mercy Hospital, Kansas City
Kansas City
Missouri
Recruiting
Washington U
St Louis
Missouri
Recruiting
Cohen's Childrens
New York
New York
Recruiting
Children's Hospital at Montefiore
The Bronx
New York
Recruiting
Duke
Durham
North Carolina
Not Yet Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati
Ohio
Recruiting
Nationwide Children's
Columbus
Ohio
Recruiting
OHSU
Portland
Oregon
Not Yet Recruiting
Children's Hospital of Philadelphia
Philadelphia
Pennsylvania
Recruiting
Children's Medical Center, Dallas
Dallas
Texas
Recruiting
Baylor College of Medicine
Houston
Texas
Recruiting
UTH
Houston
Texas
Recruiting
BC Children's Hospital Research Institute
Vancouver
British Columbia
Recruiting
SickKids
Toronto
Ontario
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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