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RECRUITING
NCT04741646
PHASE2

Ferric Citrate and Chronic Kidney Disease in Children

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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.

Official title: Phosphate Binder Therapy and Chronic Kidney Disease in Children

Key Details

Gender

All

Age Range

6 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2022-06-17

Completion Date

2027-10

Last Updated

2025-05-02

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

Placebo

Placebo to match Ferric Citrate tablets

Locations (20)

University of California, Los Angeles

Los Angeles, California, United States

Children's Hospital of Orange County

Orange, California, United States

University of California, San Francisco

San Francisco, California, United States

Arnold Palmer Hospital for Children

Orlando, Florida, United States

Emory University

Atlanta, Georgia, United States

Indiana U

Indianapolis, Indiana, United States

Children's Mercy Hospital, Kansas City

Kansas City, Missouri, United States

Washington U

St Louis, Missouri, United States

Cohen's Childrens

New York, New York, United States

Children's Hospital at Montefiore

The Bronx, New York, United States

Duke

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's

Columbus, Ohio, United States

OHSU

Portland, Oregon, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Medical Center, Dallas

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

UTH

Houston, Texas, United States

BC Children's Hospital Research Institute

Vancouver, British Columbia, Canada

SickKids

Toronto, Ontario, Canada