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RECRUITING Phase 2

Ferric Citrate and Chronic Kidney Disease in Children

NCT04741646 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG Placebo
  • DRUG Ferric Citrate

Study Locations (20)

California

  • University of California, Los Angeles — Los Angeles
  • Children's Hospital of Orange County — Orange
  • University of California, San Francisco — San Francisco

Texas

  • Children's Medical Center, Dallas — Dallas
  • Baylor College of Medicine — Houston
  • UTH — Houston

Missouri

  • Children's Mercy Hospital, Kansas City — Kansas City
  • Washington U — St Louis

New York

  • Cohen's Childrens — New York
  • Children's Hospital at Montefiore — The Bronx

Ohio

  • Cincinnati Children's Hospital Medical Center — Cincinnati
  • Nationwide Children's — Columbus

Florida

  • Arnold Palmer Hospital for Children — Orlando

Georgia

  • Emory University — Atlanta

Indiana

  • Indiana U — Indianapolis

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2022-06-17
Est. Completion 2027-10
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04741646

The ClinicalTrials.gov registry entry for NCT04741646 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 829 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Kidney Diseases appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04741646 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Texas, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04741646 about?

NCT04741646 is a clinical study titled "Ferric Citrate and Chronic Kidney Disease in Children". 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 kidn...

What is the current status of trial NCT04741646?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2022-06-17. Estimated completion is 2027-10.

What conditions does trial NCT04741646 study?

This clinical trial studies the following conditions: Chronic Kidney Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04741646?

The interventions under investigation include: Placebo (DRUG), Ferric Citrate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04741646?

This trial is sponsored by University of California, Los Angeles, which has 829 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04741646 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Indiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial