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Clinical Trials in Canada / NCT04741646
Recruiting Phase 2

Ferric Citrate and Chronic Kidney Disease in Children

NCT04741646 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2022-06-17
Last updated
2026-04-17

Condition(s) studied

Chronic Kidney Diseases

Investigational drug(s) / intervention(s)

Ferric CitratePlacebo

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)

Trial sites (20)

FacilityCityRegionStatus
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

More University of California, Los Angeles trials in Canada

Other trials for the same condition

Official registry record

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.

View NCT04741646 on ClinicalTrials.gov ↗ ← All trials in Canada