Recruiting
Phase 2

Ferric Citrate

Sponsor:

UCLA

Code:

NCT04741646

Conditions

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Interventions

Ferric Citrate

Placebo

Study Details

Brief 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.

Conditions

Chronic Kidney Diseases

Study ID

NCT04741646

Start date

Jun 17, 2022

Status verified date

Apr, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

During the 12-month trial, participants will be given a fixed weight-based dose of Ferric Citrate (FC). The full medication dose will be 3g/day for participants weighing <31 kg, 5g/day for those weighing >31 - <51 kg, and 6g/day for participants >51 kg. These doses will be divided into three doses to be taken with meals.

placebo comparator: Control Arm

During the 12-month trial, participants will be given a fixed weight-based dose of Placebo. The full medication dose will be 3g/day for participants weighing <31 kg, 5g/day for those weighing >31 - <51 kg, and 6g/day for participants >51 kg. These doses will be divided into three doses to be taken with meals.

Interventions

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

Primary outcome measure

  • iFGF23 levels [ Time Frame: 12 months ]
  • Safety of Ferric Citrate [ Time Frame: 12 months ]
  • Tolerability of Ferric Citrate [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

Isidro Salusky, MD

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

Contacts

Principal Investigator:

Shoba Nayran, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Farzana Perwad, MD

Arnold Palmer Hospital for Children

Recruiting

Orlando, Florida, United States, 32806

Contacts

Principal Investigator:

Jorge Ramirez, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Alexandria Wilkerson, BS

4047270851Awilke3@emory.edu

Principal Investigator:

Sabina Kennedy, MD

Indiana U

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Sherry Wilson

slw2@iu.edu

Principal Investigator:

khalid Myda, MD

Children's Mercy Hospital, Kansas City

Recruiting

Kansas City, Missouri, United States, 64110

Contacts

Principal Investigator:

Bradley Warady, MD

Washington U

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Principal Investigator:

Keith Hruska, MD

Cohen's Childrens

Recruiting

New York, New York, United States, 11040

Contacts

Principal Investigator:

Christina Sethna, MD

Children's Hospital at Montefiore

Recruiting

The Bronx, New York, United States, 10467

Contacts

Principal Investigator:

Frederick Kaskel, MD

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Principal Investigator:

Mark Mitsnefes, MD

Nationwide Children's

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Principal Investigator:

John Mahan, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Hannah Derwick

DERWICKH@chop.edu

Principal Investigator:

Michelle Denburg, MD

Children's Medical Center, Dallas

Recruiting

Dallas, Texas, United States, 75235

Contacts

Principal Investigator:

Raymond Quigley, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Poyyapakkam R Srivanthos, MD

UTH

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Joyce Samuel, MD

BC Children's Hospital Research Institute

Recruiting

Vancouver, British Columbia, Canada, V5Z 4H4

Contacts

Principal Investigator:

Tom Blydt-Hansen, MD

SickKids

Recruiting

Toronto, Ontario, Canada, M5G 1E8

Contacts

Yasmine Hejri-Rad

416-813-7910

Principal Investigator:

Michael Zappitelli, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • Pediatric
  • CKD
  • Phosphate Binder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-04-17.