Actively Recruiting
Ferric Citrate and Chronic Kidney Disease in Children
Led by University of California, Los Angeles · Updated on 2026-04-17
160
Participants Needed
20
Research Sites
336 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Ferric Citrate and Chronic Kidney Disease in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 6 to 18 years (inclusive)
- Estimated Glomerular Filtration Rate (GFR) of 15-59 ml/min per 1.73 m2 by modified CKD in Children (CKiD) under 25 formula
- Serum phosphate level less than or equal to 5.9 mg/dl
- Serum ferritin less than 500 ng/ml and transferrin saturation (TSAT) less than 50%
- Stable dosing for at least 2 weeks prior to screening if treated with growth hormone, calcitriol, nutritional vitamin D, iron, or erythropoiesis-stimulating agents
- Able to swallow tablets
- Able to eat at least two meals a day
- Willing and able to follow the study treatment regimen and comply with investigator recommendations
You will not qualify if you...
- Current treatment with phosphate binders
- Allergy to any ingredients in the investigational product or placebo
- Current intestinal malabsorption, inflammatory bowel syndrome, or Crohn's Disease
- Planned dialysis or kidney transplant within 6 months
- Current or planned systemic immunosuppressive therapy
- Prior solid organ transplantation
- Bone marrow transplant within two years of screening
- Current pregnancy, lactation, or female subjects post-menarche not using effective contraception
- Participation in other interventional studies
- Poor adherence to medical treatments
- Diagnosis of cystinosis
- Diagnosis of Fanconi syndrome
- Hemochromatosis or signs of iron overload syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
2
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
3
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
5
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
Indiana U
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
Children's Mercy Hospital, Kansas City
Kansas City, Missouri, United States, 64110
Actively Recruiting
8
Washington U
St Louis, Missouri, United States, 63130
Actively Recruiting
9
Cohen's Childrens
New York, New York, United States, 11040
Actively Recruiting
10
Children's Hospital at Montefiore
The Bronx, New York, United States, 10467
Actively Recruiting
11
Duke
Durham, North Carolina, United States, 27708
Not Yet Recruiting
12
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
13
Nationwide Children's
Columbus, Ohio, United States, 43205
Actively Recruiting
14
OHSU
Portland, Oregon, United States, 97239
Not Yet Recruiting
15
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
16
Children's Medical Center, Dallas
Dallas, Texas, United States, 75235
Actively Recruiting
17
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
18
UTH
Houston, Texas, United States, 77030
Actively Recruiting
19
BC Children's Hospital Research Institute
Vancouver, British Columbia, Canada, V5Z 4H4
Actively Recruiting
20
SickKids
Toronto, Ontario, Canada, M5G 1E8
Actively Recruiting
Research Team
J
JENNY BROOK, MS
CONTACT
B
Barbara Gales, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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