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Trial record 3 of 383 for:    FERRIC CATION

A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03399084
Recruitment Status : Completed
First Posted : January 16, 2018
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Sandoz

Brief Summary:
This study will evaluate bioequivalence of two formulations of Ferric Carboxymaltose as measured by serum total iron, in adult patients with iron deficiency anemia.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Ferric carboxymaltose Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-label, Randomized, Parallel, Bioequivalence Study of 750 mg Intravenous Single Dose Ferric Carboxymaltose Versus Injectafer® (750 mg Iron/15 mL Colloidal Solution) in Adult Patients With Iron Deficiency Anemia
Actual Study Start Date : November 29, 2017
Actual Primary Completion Date : January 15, 2019
Actual Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Ferric carboxymaltose (test)
Patients will receive a single dose of Ferric carboxymaltose
Drug: Ferric carboxymaltose
750 mg/15 mL

Active Comparator: Ferric carboxymaltose (reference)
Patients will receive a single dose of Ferric carboxymaltose
Drug: Ferric carboxymaltose
750 mg/15 mL




Primary Outcome Measures :
  1. Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron. [ Time Frame: Up to 7 days ]
    Measured by Cmax - The maximum plasma concentration of iron

  2. Bioequivalence assessed by area under the serum concentration-time curve (AUC) of serum total iron. [ Time Frame: Up to 7 Days ]
    Plasma Pharmacokinetics (PK) of study medication: Area Under the Plasma Concentration-time Curve (AUC)


Secondary Outcome Measures :
  1. Maximum serum concentration (Cmax) of serum transferrin-bound iron. [ Time Frame: Up to 7 days ]
    Plasma Pharmacokinetics (PK): The maximum plasma concentration

  2. Time of Cmax (Tmax) of serum total iron and transferrin-bound iron [ Time Frame: Up to 7 Days ]
    Plasma Pharmacokinetics (PK): Time of Cmax (Tmax)

  3. Area under the serum concentration-time curve (AUC) of serum transferrin-bound iron [ Time Frame: Up to 7 Days ]
    Plasma Pharmacokinetics (PK): area under the serum concentration-time curve (AUC)

  4. Apparent terminal rate constant of serum total iron and transferrin-bound iron [ Time Frame: Up to 7 Days ]
    Plasma Pharmacokinetics (PK): Apparent terminal rate constant

  5. Apparent terminal half-life of serum total iron and transferrin-bound iron [ Time Frame: Up to 7 Days ]
    Plasma Pharmacokinetics (PK): Apparent terminal half-life

  6. Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosing [ Time Frame: Up to 7 Days ]
    Plasma Pharmacokinetics (PK): Systemic clearance (CL)

  7. Volume of distribution at steady state of serum total iron and transferrin-bound iron following intravenous dosing [ Time Frame: Up to 7 Days ]
    Plasma Pharmacokinetics (PK): Volume of distribution at steady state Plasma Pharmacokinetics (PK): Volume of distribution at steady state (Vss)

  8. Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: Up to 7 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients at least 18 - 65 years of age;
  • Patients with a body mass index (BMI) between 18.5 - 35 and with a body weight of ≥50 kg - ≤130 kg;

Exclusion Criteria:

  • Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product
  • Patients with chronic kidney disease who are on dialysis of any kind.
  • If female, is pregnant or nursing.
  • Patients with blood loss leading to hemodynamic instability
  • Patients with recent parenteral iron within 3 months prior to screening.

Other inclusion/exclusion criteria may apply.


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): NCT03399084


Locations
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United States, Florida
Sandoz Investigative Site
Miami, Florida, United States, 33143
Sponsors and Collaborators
Sandoz
Investigators
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Study Director: Sandoz Sandoz Novartis Pharmaceuticals

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Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT03399084     History of Changes
Other Study ID Numbers: 1637 FCM_1
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sandoz:
Ferric carboxymaltose
Anemia
Additional relevant MeSH terms:
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Ferric Compounds
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Hematinics