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Ferric Citrate and Chronic Kidney Disease in Children

RecruitingPhase 2

Phosphate Binder Therapy and Chronic Kidney Disease in Children

Who can join

Ages 6 to 18 · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: University of California, Los Angeles · Participants: 160 · Started: Jun 17, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT04741646

Locations in the U.S.

CaliforniaUniversity of California, Los Angeles, Los Angeles
Children's Hospital of Orange County, Orange
University of California, San Francisco, San Francisco
FloridaArnold Palmer Hospital for Children, Orlando
GeorgiaEmory University, Atlanta
IndianaIndiana U, Indianapolis
MissouriChildren's Mercy Hospital, Kansas City, Kansas City
Washington U, St Louis
New YorkCohen's Childrens, New York
Children's Hospital at Montefiore, The Bronx
North CarolinaDuke, Durham (Not yet recruiting)
OhioCincinnati Children's Hospital Medical Center, Cincinnati
Nationwide Children's, Columbus
OregonOHSU, Portland (Not yet recruiting)
PennsylvaniaChildren's Hospital of Philadelphia, Philadelphia
TexasChildren's Medical Center, Dallas, Dallas
Baylor College of Medicine, Houston
UTH, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.