Ferric Citrate for Chronic Kidney Disease in Children
This study is looking at how Ferric Citrate (Auryxia®) affects children aged 6 to 18 with chronic kidney disease (CKD) stages 3-4. We want to see if Ferric Citrate can change levels of a protein called iFGF23, which is important in kidney health. Participants will receive either Ferric Citrate or a placebo (an inactive pill that looks the same) for 12 months. We're also checking the safety and how well children tolerate Ferric Citrate. To join, your child needs to be between 6 and 18 years old, have a specific kidney function level (GFR of 15-59 ml/min per 1.73 m2), and have certain blood test results for phosphate, ferritin, and TSAT. We plan to enroll 160 children in total.
- Study design
- This is a double-blind, randomized, placebo-controlled study involving 160 participants. Participants will be randomly assigned to receive either Ferric Citrate or a placebo.
- What's involved
- Participants will take a daily dose of Ferric Citrate or placebo for 12 months. Blood samples for primary outcome assessments will be collected at screening, baseline, and at months 3, 6, 9, and 12. Blood for safety assessments will be collected at months 1, 2, 3, 6, 9, and 12.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for this study are measured at 12 months, which is the duration of the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Ferric Citrate and Chronic Kidney Disease in Children
At a glance
Conditions
NCT04741646
Where you'd take part
This study runs at 20 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Arnold Palmer Hospital for Children
Orlando, Floridastudy coordinator listed
Recruiting
Baylor College of Medicine
Houston, Texasstudy coordinator listed
Recruiting
BC Children's Hospital Research Institute
Vancouver, British Columbia, Canadastudy coordinator listed
Recruiting
Children's Hospital at Montefiore
The Bronx, New Yorkstudy coordinator listed
Recruiting
Children's Hospital of Orange County
Orange, Californiastudy coordinator listed
Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Children's Medical Center, Dallas
Dallas, Texasstudy coordinator listed
Recruiting
Children's Mercy Hospital, Kansas City
Kansas City, Missouristudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Isidro B Salusky, MD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- iFGF23 levels12 months
Compared to placebo, active treatment with FC will lower iFGF23 levels
- Safety of Ferric Citrate12 months
Comparing proportion of subjects with AE and SAE between arms
- Tolerability of Ferric Citrate12 months
Compared with placebo, active treatment will be tolerable