Ferric Citrate and Chronic Kidney Disease in Children (FIT4KID)

June 20, 2023 updated by: Isidro Salusky, MD, University of California, Los Angeles

Phosphate Binder Therapy 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 6-17 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 12 core clinical sites.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

We will conduct a 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) aged 6-17 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 12 core clinical sites.

Schedule of Intervention: During the 12-month trial, participants will be given a daily fixed weight-based dose of FC.

Schedule for data collection/analyses to be performed:

Blood for primary outcome assessments will be collected at screening, baseline and at months 1, 2, 3, 6, 9, 12. Blood for safety assessments will be collected at the same intervals.

The primary analyses for this 2-arm trial will evaluate changes from baseline in iFGF23 levels over 12 months between the treatment and the placebo arms. The analysis will use a linear mixed-effects model, with random participant effects accounting for repeated measurements, random site effects accounting for clustering of participants into study sites, and a fixed treatment effect, which interacts with a time indicator (Months 3-12 vs. Months 1-3).

Primary objectives:

  • To assess the effects of therapy with FC on changes in iFGF23 levels
  • To determine safety and tolerability of FC.

Secondary objectives:

• To assess the effects of FC on anemia and indices of mineral and bone metabolism.

Primary Endpoint:

• Change in iFGF23 level

Safety and Tolerability Endpoints:

• Ability to safely tolerate FC

Secondary Endpoints:

  • Change in anemia
  • Change in the indices of mineral and bone metabolism

This is a Phase 2 study with participation from 12 sites that will take 36 months to complete enrollment and a total of 48 months to complete data collection with each participant being part of the study for 12 months.

Study website: fit4kid.dgsom.ucla.edu

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4H4
        • Recruiting
        • BC Children's Hospital Research Institute
        • Contact:
        • Principal Investigator:
          • Tom Blydt-Hansen, MD
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles
        • Contact:
        • Principal Investigator:
          • Isidro Salusky, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Principal Investigator:
          • Farzana Perwad, MD
        • Sub-Investigator:
          • Anthony Portale, MD
    • Florida
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Arnold Palmer Hospital for Children
        • Principal Investigator:
          • Jorge Ramirez, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Laurence Greenbaum, MD
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64110
        • Recruiting
        • Children's Mercy Hospital, Kansas City
        • Contact:
        • Principal Investigator:
          • Bradley Warady, MD
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Children's Hospital at Montefiore
        • Contact:
        • Principal Investigator:
          • Frederick Kaskel, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Mark Mitsnefes, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Michelle Denburg, MD
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Children's Medical Center, Dallas
        • Contact:
        • Principal Investigator:
          • Raymond Quigley, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Principal Investigator:
          • Poyyapakkam R Srivanthos, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ages 6 to 17 years (inclusive);
  2. Estimated GFR of 15-59 ml/min per 1.73 m2 by modified CKiD formula;56
  3. Serum phosphate within age appropriate normal levels;
  4. Serum ferritin <500 ng/ml and TSAT <50%;
  5. For those patients treated with growth hormone, calcitriol, nutritional vitamin D, iron, and/or 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. Perform physical exam and obtain vitals.
  2. Check urine pregnancy test in menstruating female participants and administer corresponding questionnaire.
  3. Administer GI Symptom questionnaire.
  4. Ascertain AEs.
  5. Obtain information on concomitant medications.
  6. Process 24-hour urine sample for 24 hour urine creatinine and phosphate.
  7. Measure run-in adherence using eCAP system and pill count.
  8. Administer the Medical Adherence Measure tool.
  9. Reinforce adherence.
  10. Prepare one month's supply of drug and enter them into eCAP system.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Ferric Citrate
Auryxia® 210 mg ferric iron tablets equivalent to 1 g of FC and matching placebo will be supplied as 200 tablets in 400cc high-density polyethylene bottles.
Other Names:
  • Auryxia
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.
Drug: Placebo
Placebo to match Ferric Citrate tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iFGF23 levels
Time Frame: 6 months and 12 months
Change in iFGF23 levels
6 months and 12 months
Safety of Ferric Citrate
Time Frame: 12 months
Safety of FC will be compared to Placebo through measures of Adverse Events
12 months
Tolerability of Ferric Citrate
Time Frame: 12 months
Tolerability of FC will be compared to Placebo through measures of Adverse Events
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects on Hemoglobin
Time Frame: 12 months
Increase in Hemoglobin will be compared between FC and Placebo
12 months
Effects on TSAT
Time Frame: 12 months
Increase in TSAT will be compared between FC and Placebo
12 months
Effects on Ferritin
Time Frame: 12 months
Increase in Ferritin will be compared between FC and Placebo
12 months
Effects on PTH
Time Frame: 12 months
Increase in PTH will be compared between FC and Placebo
12 months
Effects on 1,25 D
Time Frame: 12 months
Decrease in 1,25 D will be compared between FC and Placebo
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Isidro B Salusky, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 2, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1U01DK122013-01 (U.S. NIH Grant/Contract)
  • 1U01DK122013 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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