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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04523727
Recruitment Status : Not yet recruiting
First Posted : August 24, 2020
Last Update Posted : October 30, 2020
Sponsor:
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 participant 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 : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 36-week, Single-group, 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 2020
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Ferric citrate
Participants aged 12 to <18 years and 6 to <12 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 [ 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 36/early termination (ET) [ Time Frame: Baseline; up to Week 36 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weight ≥12 kg at Screening
  • Chronic kidney disease (CKD) requiring 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
  • At Screening:

    a) If participant is on phosphate binder(s):

    • At Visit 1, the participant, if eligible per all other inclusion and exclusion criteria, will discontinue phosphate binder(s) and proceed to the Washout period.
    • After at least 1 week of washout (i.e., at Visit 1a or Visit 1b), serum phosphorus must be:
  • 6 to <13 years: >5.8 milligrams per deciliter (mg/dl);
  • 13 to <18 years: >4.5 mg/dl. b) If participant is not on a phosphate binder:

    • At Visit 1, serum phosphorus must be:

  • 6 to <13 years: >5.8 mg/dl;
  • 13 to <18 years: >4.5 mg/dl.
  • Serum ferritin <500 nanograms per milliliter (ng/ml) at Screening
  • Parent/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 at Screening.

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, or tube feeding required
  • 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
  • Receiving immunosuppressive medication for a functioning organ transplant
  • A known allergy or intolerance to ferric citrate or any of its constituents
  • Female participants of childbearing potential who are unwilling to use adequate contraception
  • Pregnant or breast-feeding, if female
  • 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


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

Sponsors and Collaborators
Keryx Biopharmaceuticals
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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 30, 2020
Last Verified: October 2020
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:
hyperphosphatemia
chronic kidney disease
CKD
ferric citrate
pediatric
dialysis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases