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Ferric Citrate and Chronic Kidney Disease in Children (FIT4KID)

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ClinicalTrials.gov Identifier: NCT04741646
Recruitment Status : Not yet recruiting
First Posted : February 5, 2021
Last Update Posted : February 5, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Isidro Salusky, MD, University of California, Los Angeles

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 6-17 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Drug: Ferric Citrate Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phosphate Binder Therapy and Chronic Kidney Disease in Children
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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.

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




Primary Outcome Measures :
  1. iFGF23 levels [ Time Frame: 6 months and 12 months ]
    Change in iFGF23 levels

  2. Safety of Ferric Citrate [ Time Frame: 12 months ]
    Safety of FC will be compared to Placebo through measures of Adverse Events

  3. Tolerability of Ferric Citrate [ Time Frame: 12 months ]
    Tolerability of FC will be compared to Placebo through measures of Adverse Events


Secondary Outcome Measures :
  1. Effects on Hemoglobin [ Time Frame: 12 months ]
    Increase in Hemoglobin will be compared between FC and Placebo

  2. Effects on TSAT [ Time Frame: 12 months ]
    Increase in TSAT will be compared between FC and Placebo

  3. Effects on Ferritin [ Time Frame: 12 months ]
    Increase in Ferritin will be compared between FC and Placebo

  4. Effects on PTH [ Time Frame: 12 months ]
    Increase in PTH will be compared between FC and Placebo

  5. Effects on 1,25 D [ Time Frame: 12 months ]
    Decrease in 1,25 D will be compared between FC and Placebo



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04741646


Contacts
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Contact: JENNY BROOK, MS 310-7943144 jbrook@mednet.ucla.edu
Contact: Barbara Gales, RN bgales@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Contact: Barbara Gales, RN    310-206-0799    bgales@mednet.ucla.edu   
Principal Investigator: Isidro Salusky, MD         
University of California, San Francisco
San Francisco, California, United States, 94143
Contact: Daniel Schrader    415-476-9657    daniel.schrader@ucsf.edu   
Principal Investigator: Anthony Portale, MD         
United States, Florida
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Principal Investigator: Jorge Ramirez, MD         
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Contact: Anjali Khanna    470-867-7765    anjali.khanna@emory.edu   
Contact: Mone Anzai    404-712-9923    mone.anzai@emory.edu   
Principal Investigator: Laurence Greenbaum, MD         
United States, Missouri
Children's Mercy Hospital, Kansas City
Kansas City, Missouri, United States, 64110
Contact: Stephen Morrison    816-302-3573    ssmorrison@cmh.edu   
Principal Investigator: Bradley Warady, MD         
United States, New York
Children's Hospital at Montefiore
Bronx, New York, United States, 10467
Contact: Patricia Flynn    718-655-1120    pflynn@montefiore.org   
Principal Investigator: Frederick Kaskel, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Contact: Bliss Magella, PhD    513-636-7832    bliss.magella@cchmc.org   
Principal Investigator: Mark Mitsnefes, MD         
United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Contact: Nia Nichols    215-427-4294    nia.nichols@towerhealth.org   
Principal Investigator: Joshua Zaritsky, MD         
United States, Texas
Children's Medical Center, Dallas
Dallas, Texas, United States, 75235
Contact: Melaku Lemma    214-456-8577    melaku.lemma@childrens.com   
Principal Investigator: Raymond Quigley, MD         
Baylor College of Medicine
Houston, Texas, United States, 77030
Contact: Saima Deen    832-824-7783    sxdeen@texaschildrens.org   
Principal Investigator: Poyyapakkam R Srivanthos, MD         
Canada, British Columbia
BC Children's Hospital Research Institute
Vancouver, British Columbia, Canada, V5Z 4H4
Contact: Mike Guron    604-875-2000 ext 7255    mike.guron@bcchr.ca   
Contact: Julie Matheson    604-875-2000 ext 7558    jmatheson@bcchr.ca   
Principal Investigator: Tom Blydt-Hansen, MD         
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Isidro B Salusky, MD University of California, Los Angeles
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Responsible Party: Isidro Salusky, MD, Distinguished Professor of Pediatrics at the David Geffen School of Medicine at UCLA, Chief of Pediatric Nephrology and Director of the Pediatric Dialysis Program, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04741646    
Other Study ID Numbers: 1U01DK122013-01 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Isidro Salusky, MD, University of California, Los Angeles:
Pediatric
CKD
Phosphate Binder
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency