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Study to Evaluate the Safety and Tolerability of Ferric Citrate in Children With Hyperphosphatemia Related to Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT04523727
Recruitment Status : Not yet recruiting
First Posted : August 24, 2020
Last Update Posted : October 12, 2022
Information provided by (Responsible Party):
Keryx Biopharmaceuticals

Brief Summary:
This study will be conducted to assess the safety and tolerability of ferric citrate in pediatric participants with hyperphosphatemia related to chronic kidney disease (CKD).

Condition or disease Intervention/treatment Phase
Hyperphosphatemia Related to Chronic Kidney Disease Drug: ferric citrate Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 36-week, Single-Arm, Open-label Study to Evaluate the Safety and Tolerability of Ferric Citrate in Children With Hyperphosphatemia Related to Chronic Kidney Disease
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : June 2024

Arm Intervention/treatment
Experimental: Ferric citrate
Participants aged 12 to < 17 years will receive ferric citrate for 36 weeks at a starting dose based on body weight categories.
Drug: ferric citrate
oral tablets
Other Name: KRX-0502

Primary Outcome Measures :
  1. Number of participants with serious and non-serious treatment-emergent adverse events (AEs) including gastrointestinal (GI) AEs of special interest [ Time Frame: up to Week 40 ]
  2. Number of participants with clinically significant laboratory abnormalities [ Time Frame: up to Week 40 ]
  3. Number of participants with treatment-emergent adverse events leading to the discontinuation of ferric citrate [ Time Frame: up to Week 40 ]

Secondary Outcome Measures :
  1. Change from baseline in serum phosphorus to Week 12/early termination (ET) [ Time Frame: Baseline; up to Week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Weight ≥ 40 kilograms (kg) (dry weight for dialysis participants) at Screening
  • Chronic kidney disease (CKD) requiring chronic dialysis (i.e., hemodialysis or peritoneal dialysis), or CKD not on dialysis with an estimated glomerular filtration rate (eGFR) <30 milliliters per minute (mL/min)/1.73 meters squared (m^2) at Screening
  • Documented history of CKD-related hyperphosphatemia for at least 3 months prior to the screening visit.
  • If participant is on phosphate binder(s) after at least 1 week of washout (i.e., at Visit 1a or Visit 1b) or if participant is not on phosphate binder(s) at Visit 1, serum phosphorus must be:

    • 12 years: >5.8 milligrams per deciliter (mg/dL).
    • 13 to <17 years: >4.5 mg/dL.
  • Transferrin saturation (TSAT) <50%.
  • Serum ferritin <500 nanograms per milliliter (ng/mL).
  • Parent/legal guardian must be willing and able to give written informed consent, and child (participant) willing and able to give age-appropriate assent according to local regulatory requirements.
  • Female participants of childbearing potential, defined as post menarche and not surgically sterile, must have a negative serum pregnancy test.
  • Dialysis adequacy stable for at least 2 months prior to screening and agree to maintain dialysis prescription for the duration of the pharmacodynamic assessment period unless changes are needed for safety. A minimum dialysis adequacy (dialysis clearance of urea-dialysis time/volume of distribution of urea [Kt/V]), defined by the following:

    • Hemodialysis adequacy: single-pool Kt/V ≥1.2 for at least 1 hemodialysis session within 2 months.
    • Peritoneal dialysis: Kt/V ≥1.8 (or per local guidance) within 4 months.

Exclusion Criteria:

  • Active significant gastrointestinal (GI) disorder, including overt GI bleeding or active inflammatory bowel disease
  • Liver transaminases (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) >3× the upper limit of normal at Screening
  • Unable to swallow pills, if participant requires tube feeding, ferric citrate must be taken orally and not administered via feeding tube).
  • Non-renal cause of hyperphosphatemia
  • Active drug or alcohol dependence or abuse (excluding tobacco use or medicinal marijuana) within the 12 months prior to Screening or evidence of such abuse (in the opinion of the Investigator)
  • Malignancy, except for participants who have been disease-free for at least 2 years after curative therapy
  • Participants with a functioning organ transplant
  • A known allergy or intolerance to ferric citrate or any of its constituents
  • Participants who do not agree to remain abstinent or assent to use a combination of 2 of the following highly effective birth control methods for at least 28 days before the first dose, during the study (including during dose interruptions), and for at least 30 days after the last dose:

    • Barrier method of contraception: condoms (female or male) with or without a spermicidal agent, diaphragm, or cervical cap with spermicide.
    • Intrauterine device (IUD).
    • Hormone-based contraceptives which are associated with inhibition of ovulation
  • Females who are pregnant or breast-feeding.
  • Any other medical condition that, in the opinion of the Investigator, renders the participant unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the participant
  • The participant, in the opinion of the Investigator, is unable to adhere to the requirements of the study
  • Receipt of any investigational drug within 4 weeks before Screening
  • History of hemochromatosis or iron overload syndrome (e.g., hereditary sideroblastic anemia, thalassemia)

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): NCT04523727

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Contact: Akebia Medical Information 1-844-445-3799 medicalinfo@akebia.com

Sponsors and Collaborators
Keryx Biopharmaceuticals
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Study Director: Chief Medical Officer Akebia Therapeutics Inc.
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Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT04523727    
Other Study ID Numbers: KRX-0502-308
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Keryx Biopharmaceuticals:
chronic kidney disease
ferric citrate
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases