NCT04741646 · University of California, Los Angeles
Ferric Citrate and Chronic Kidney Disease in Children
(FIT4KID)
What this study is about
We will conduct a 12-month, where neither patients nor doctors know which treatment is given, randomly assigned, compared against an inactive treatment trial to assess the effects of therapy with ferric citrate (FC) on changes in intact FGF23 levels (iFGF23, primary goal measurement) in 160 pediatric patients (80 in each of the two treatment group$1) 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 randomly assigned to one of the two groups: 1) FC or 2) FC placebo. Participants will be recruited from 20
View original scientific description
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.
Interventions
DRUG
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.
DRUG
Placebo
Placebo to match Ferric Citrate tablets
Primary outcome measures
iFGF23 levels
Time frame: 12 months
Compared to placebo, active treatment with FC will lower iFGF23 levels
Safety of Ferric Citrate
Time frame: 12 months
Comparing proportion of subjects with AE and SAE between arms
Tolerability of Ferric Citrate
Time frame: 12 months
Compared with placebo, active treatment will be tolerable
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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 me
Where
- Los Angeles, California
- Orange, California
- San Francisco, California
- Orlando, Florida
- Atlanta, Georgia
- Indianapolis, Indiana
- Kansas City, Missouri
- St Louis, Missouri
- New York, New York
- The Bronx, New York
- Durham, North Carolina
- Cincinnati, Ohio
And 5 more locations — see the full list below.
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 17, 2026 · Source of record for eligibility and locations