NCT04741646

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
32mo left

Started Jun 2022

Longer than P75 for phase_2

Geographic Reach
2 countries

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jun 2022Nov 2028

First Submitted

Initial submission to the registry

February 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 17, 2022

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

5.3 years

First QC Date

February 2, 2021

Last Update Submit

April 14, 2026

Conditions

Chronic Kidney Diseases

Keywords

PediatricCKDPhosphate Binder

Outcome Measures

Primary Outcomes (3)

  • iFGF23 levels

    Compared to placebo, active treatment with FC will lower iFGF23 levels

    12 months

  • Safety of Ferric Citrate

    Comparing proportion of subjects with AE and SAE between arms

    12 months

  • Tolerability of Ferric Citrate

    Compared with placebo, active treatment will be tolerable

    12 months

Secondary Outcomes (2)

  • Effects on Transferrin Saturation (TSAT)

    12 months

  • Effects on PTH and 1,25 D

    12 months

Other Outcomes (9)

  • GFR

    12 months

  • Osteoid thickness

    12 months

  • Effects on bone expression

    12 months

  • +6 more other outcomes

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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.

Drug: Ferric Citrate

Control Arm

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Ferric CitrateDRUG

Auryxia® 210 mg ferric iron tablets equivalent to 1 g of FC will be supplied as 200 tablets in 400cc high-density polyethylene bottles.

Also known as: Auryxia
Treatment Arm
PlaceboDRUG

Placebo to match Ferric Citrate tablets

Control Arm

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages 6 to 18 years (inclusive);
  • 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
  • Serum phosphate \<=5.9 mg/dl;
  • Serum ferritin \<500 ng/ml and TSAT \<50%;
  • 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;
  • Able to swallow tablets;
  • Able to eat at least two meals a day;
  • In the opinion of the investigator, willing and able to follow the study treatment regimen and comply with the site investigator's recommendations.

You may not qualify if:

  • Patients currently treated with phosphate binders.
  • History of allergy to all ingredients (including non-medical ingredients) in both products (i.e. investigational product and placebo)
  • Current intestinal malabsorption, documented in the medical record; disease, inflammatory bowel syndrome, and/or Crohn's Disease.
  • Anticipated initiation of dialysis or kidney transplantation within 6 months
  • Current or planned future systemic immunosuppressive therapy
  • Prior solid organ transplantation
  • Receipt of bone marrow transplant within two years of screening
  • Current pregnancy, lactation or female subjects who have reached menarche, unless using highly-effective contraception as outlined in section 7.1.1 of Protocol
  • Patients participating in other interventional study (observational study participation permitted)
  • Poor adherence to medical treatments in the opinion of the investigator
  • Cystinosis
  • Fanconi syndrome
  • Hemochromatosis or laboratory tests indicating possible hemochromatosis or other iron overload (primary or secondary) syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Children's Hospital of Orange County

Orange, California, 92868, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Indiana U

Indianapolis, Indiana, 46202, United States

RECRUITING

Children's Mercy Hospital, Kansas City

Kansas City, Missouri, 64110, United States

RECRUITING

Washington U

St Louis, Missouri, 63130, United States

RECRUITING

Cohen's Childrens

New York, New York, 11040, United States

RECRUITING

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

RECRUITING

Duke

Durham, North Carolina, 27708, United States

NOT YET RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Nationwide Children's

Columbus, Ohio, 43205, United States

RECRUITING

OHSU

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Children's Medical Center, Dallas

Dallas, Texas, 75235, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

UTH

Houston, Texas, 77030, United States

RECRUITING

BC Children's Hospital Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

RECRUITING

SickKids

Toronto, Ontario, M5G 1E8, Canada

RECRUITING

Related Publications (1)

  • Hanudel MR, Laster ML, Portale AA, Dokras A, Quigley RP, Guzman GAL, Zaritsky JJ, Hayde NA, Kaskel FJ, Mitsnefes MM, Ramirez JA, Imani PD, Srivaths PR, Kogon AJ, Denburg MR, Blydt-Hansen TD, Reyes LZ, Greenbaum LA, Weidemann DK, Warady BA, Elashoff DA, Mendley SR, Isakova T, Salusky IB. A review of ferric citrate clinical studies, and the rationale and design of the Ferric Citrate and Chronic Kidney Disease in Children (FIT4KiD) trial. Pediatr Nephrol. 2022 Nov;37(11):2547-2557. doi: 10.1007/s00467-022-05492-7. Epub 2022 Mar 2.

    PMID: 35237863DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

ferric citrate

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Isidro B Salusky, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JENNY BROOK, MS

CONTACT

310-7943144jbrook@mednet.ucla.edu

Barbara Gales, RN

CONTACT

310-206-0799bgales@mednet.ucla.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor of Pediatrics at the David Geffen School of Medicine at UCLA, Chief of Pediatric Nephrology and Director of the Pediatric Dialysis Program

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 5, 2021

Study Start

June 17, 2022

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 30, 2028

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

All de-identified clinical data, including study outcomes and participant characteristics will be submitted to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository at the completion of the study. De-identified research samples blood and urine will also be provided to the NIDDK central reporsitory

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
the IPD will become available 12 months after study completion.
Access Criteria
Access will be provided by National Institute of Health and any researcher will be able to request access from NIH once the data becomes available.

Locations

US(18)CA(2)