RecruitingPhase 2NCT04741646

Ferric Citrate and Chronic Kidney Disease in Children

Phosphate Binder Therapy and Chronic Kidney Disease in Children

Sponsor

University of California, Los Angeles

Enrollment

160 participants

Start Date

Jun 17, 2022

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Diseases

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.

Eligibility

Min Age: 6 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests ferric citrate — an iron-based medication — in children with chronic kidney disease (CKD) to see if it can help control phosphorus levels in the blood (which build up when kidneys aren't working well) while also improving iron stores and reducing anemia. **You may be eligible if...** - You are between 6 and 18 years old - You have chronic kidney disease with an estimated kidney function (GFR) of 15–59 - Your phosphorus and iron levels fall within the study's required ranges - Any current treatments (growth hormone, iron supplements, etc.) have been stable for at least 2 weeks **You may NOT be eligible if...** - You are on dialysis - Your phosphorus or ferritin levels are too high - You have had a recent serious illness or hospitalization - You have a known intolerance to iron supplements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFerric 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.

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04741646

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