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Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent 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: NCT04649411
Recruitment Status : Not yet recruiting
First Posted : December 2, 2020
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Keryx Biopharmaceuticals

Study Description
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Brief Summary:
This study will be conducted to evaluate the safety and tolerability of ferric citrate in pediatric participants with iron deficiency anemia (IDA) associated with non-dialysis dependent chronic kidney disease (NDD-CKD).

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease Drug: ferric citrate Drug: standard of care Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 24-Week, Open-Label, Randomized, 2-Arm Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
Estimated Study Start Date : May 2022
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ferric citrate
Participants aged 12 to <18 years and 6 to <12 years will receive ferric citrate for 24 weeks at a starting dose based on body weight categories.
 Drug: ferric citrate
oral tablets
Other Name: KRX-0502
Active Comparator: Standard of care
Participants aged 12 to <18 years and 6 to <12 years will receive standard of care treatment for 24 weeks.
 Drug: standard of care
administered per the approved label and at the Investigator's discretion


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Serious and Non-serious Treatment-emergent Adverse Events [ Time Frame: up to Week 28 ]
  2. Number of Participants with Clinically Significant Laboratory Abnormalities or Changes in Laboratory Results [ Time Frame: up to Week 24 ]
  3. Number of Participants with Treatment-emergent Adverse Events Leading to the Discontinuation of Ferric Citrate [ Time Frame: up to Week 28 ]

Secondary Outcome Measures :
  1. Change from Baseline in Hemoglobin to Week 24/Early Termination Visit [ Time Frame: Baseline; Week 24 ]
  2. Change from Baseline in Transferrin Saturation (TSAT) to Week 24/Early Termination Visit [ Time Frame: Baseline; Week 24 ]
  3. Change from Baseline in Ferritin to Week 24/Early Termination Visit [ Time Frame: Baseline; Week 24 ]
  4. Change from Baseline in Serum Phosphorus to Week 24/Early Termination Visit [ Time Frame: Baseline; Week 24 ]
  5. Change from Baseline in Calcium to Week 24/Early Termination Visit [ Time Frame: Baseline; Week 24 ]
  6. Change from Baseline in Bicarbonate to Week 24/Early Termination Visit [ Time Frame: Baseline; Week 24 ]

Eligibility Criteria
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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:

  • Age 6 years to <18 years at Screening
  • Body Weight ≥12 kilograms (kg) at Screening
  • Chronic kidney disease (CKD) stage 3 to 5, not on dialysis, with estimated glomerular filtration rate (eGFR) <60 milliliters per minute (mL/min)/1.73 meters squared (m^2) utilizing the "Bedside Schwartz" equation
  • Hemoglobin (Hgb) ≥8.5 and ≤11.5 grams per deciliter (g/dL) at Screening
  • Transferrin saturation (TSAT) ≤25% at Screening
  • Ferritin ≤200 nanograms per milliliter (ng/mL) at Screening

Exclusion Criteria:

  • Serum phosphorus level at Screening:

    • 6 to <13 years: ≤4.0 milligrams per deciliter (mg/dL);
    • 13 to <18 years: ≤2.7 mg/dL
  • Liver transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) ˃3× the upper limit of normal at Screening
  • Active significant gastrointestinal (GI) disorder, including overt gastrointestinal (GI) bleeding or active inflammatory bowel disease
  • Unable to swallow pills
  • Anemia due to causes other than iron deficiency anemia (IDA) of CKD
  • Intravenous iron therapy or blood transfusion within 4 weeks before the Screening visit
  • Participants with a functioning organ transplant
  • Receipt of any investigational drug within 4 weeks before Screening
  • Phosphate binder use during the Screening period
Contacts and Locations
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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): NCT04649411


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

Sponsors and Collaborators
Keryx Biopharmaceuticals
More Information
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Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT04649411    
Other Study ID Numbers: KRX-0502-309
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
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:
Iron Deficiency Anemia
Non-Dialysis Dependent Chronic Kidney Disease
CKD
 ferric citrate
pediatric
dialysis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Urologic Diseases
 Renal Insufficiency
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders