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A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)

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ClinicalTrials.gov Identifier: NCT03619850
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.

Brief Summary:

Primary Objectives:

To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA

Secondary Objective:

To determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol in pediatric subjects.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease; Iron Deficiency Anemia Drug: Ferumoxytol Drug: Iron sucrose Phase 3

Detailed Description:

This is a Phase 3, randomized, open-label, multicenter, study of the safety (compared to iron sucrose), efficacy, and PK/PD of ferumoxytol (7.0 mg Fe/kg x 2 [max 510 mg/dose]) in pediatric subjects with iron deficiency anemia (IDA) and CKD. There will be a total of approximately 125 subjects randomized to treatment in a 2:1 ratio to either ferumoxytol or iron sucrose.

Total subject participation in the study will be up to 7 weeks, which includes a 2-week Screening Period and a 5-week Treatment Period.

Subjects receive the following:

• Two IV infusions of ferumoxytol 7.0 mg Fe/kg (max 510 mg/dose), the first administered on Day 1 and the second 2-8 days later

OR

• Iron sucrose (Venofer®): For Hemodialysis Dependent (HDD) patients: 2 mg Fe/kg, administered on consecutive dialysis sessions, for 10 doses (max 100mg/dose with a total max treatment course of 1000mg) For Non-hemodialysis Dependent (NDD) or Peritoneal Dialysis De pendent(PDD) patients: 4 mg Fe/kg, administered up to 3 times/week, for 5 doses (max 200mg/dose with a total max treatment course of 1000mg).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)
Actual Study Start Date : August 13, 2018
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ferumoxytol Drug: Ferumoxytol
Each 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg Fe/mL, coated with polyglucose sorbitol carboxymethylether and formulated with mannitol, at a concentration of 44 mg/mL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution.
Other Name: Feraheme

Active Comparator: Iron sucrose Drug: Iron sucrose
Each mL contains 20 mg of elemental iron as iron sucrose in water for injection. The 5 mL single-use vial contains 100 mg of iron per 5 mL. The drug product contains approximately 30% sucrose (300 mg/mL).
Other Name: Venofer




Primary Outcome Measures :
  1. Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5 [ Time Frame: 35 days ]
    Proportion of patients achieving a hemoglobin change of at least 0.5 g/dL during the period from Baseline to Week 5


Secondary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events [ Time Frame: 49 days ]
    Incidence of Treatment Emergent Adverse Events

  2. Incidence of adverse events of special interest (AESI) [ Time Frame: 49 days ]
    Incidence of adverse events of special interest (AESI) (hypotension and hypersensitivity)


Other Outcome Measures:
  1. Area Under the Curve (AUC) [ Time Frame: 35 days ]
    Pharmacokinetic parameter: Area Under the Curve (AUC)

  2. Clearance [ Time Frame: 35 days ]
    Pharmacokinetic parameter: clearance

  3. Distribution and elimination half-lives [ Time Frame: 35 days ]
    Pharmacokinetic parameter: distribution and elimination half-lives



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

Inclusion Criteria:

  1. Male or female 2 years to <18 years of age at time of consent
  2. Has IDA defined as: a) hemoglobin <12.0 g/dL and b) with either transferrin saturation (TSAT) <40% or ferritin <100 ng/mL; or considered to be at risk of development of IDA, i.e., TSAT<20% with falling hemoglobin during the preceding 2 months and a history of hemoglobin <12 g/dL
  3. Has Chronic Kidney Disease defined as one of the following:

    1. on chronic hemodialysis;
    2. receiving chronic peritoneal dialysis;
    3. estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2;
    4. has evidence of structural and/or functional abnormalities e.g., persistent albuminuria, abnormal urine sediment, electrolyte and other abnormalities due to tubular disorders for > 3 months.
  4. For patients other than hemodialysis dependent CKD patients, documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate
  5. All subjects (female and male) of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Day 1 Dosing and agree to remain on birth control until completion of the study

Exclusion Criteria:

  1. Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose
  2. History of allergy to intravenous (IV) iron
  3. History of multiple drug allergies (>2)
  4. Low systolic blood pressure (Age 1-9 years <70 + [age in years x 2] mmHg, Age 10-17 years <90 mmHg)
  5. Hemoglobin ≤7.0 g/dL
  6. Serum ferritin level >600 ng/mL

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): NCT03619850


Contacts
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Contact: Clinical Trial Interest 1-877-233-4781 AMAGCT@druginfo.com

Locations
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Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
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Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03619850    
Other Study ID Numbers: AMAG-FER-CKD-354
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 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 AMAG Pharmaceuticals, Inc.:
Iron deficiency anemia (IDA)
chronic kidney disease (CKD)
pediatrics
ferumoxytol
iron sucrose
Feraheme
Venofer
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
Ferrosoferric Oxide
Ferric Oxide, Saccharated
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions