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

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

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

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Drug: Ferric carboxymaltose

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • Sandoz Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron.	Measured by Cmax - The maximum plasma concentration of iron	Up to 7 days
Bioequivalence assessed by area under the serum concentration-time curve (AUC) of serum total iron.	Plasma Pharmacokinetics (PK) of study medication: Area Under the Plasma Concentration-time Curve (AUC)	Up to 7 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum serum concentration (Cmax) of serum transferrin-bound iron.	Plasma Pharmacokinetics (PK): The maximum plasma concentration	Up to 7 days
Time of Cmax (Tmax) of serum total iron and transferrin-bound iron	Plasma Pharmacokinetics (PK): Time of Cmax (Tmax)	Up to 7 Days
Area under the serum concentration-time curve (AUC) of serum transferrin-bound iron	Plasma Pharmacokinetics (PK): area under the serum concentration-time curve (AUC)	Up to 7 Days
Apparent terminal rate constant of serum total iron and transferrin-bound iron	Plasma Pharmacokinetics (PK): Apparent terminal rate constant	Up to 7 Days
Apparent terminal half-life of serum total iron and transferrin-bound iron	Plasma Pharmacokinetics (PK): Apparent terminal half-life	Up to 7 Days
Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosing	Plasma Pharmacokinetics (PK): Systemic clearance (CL)	Up to 7 Days
Volume of distribution at steady state of serum total iron and transferrin-bound iron following intravenous dosing	Plasma Pharmacokinetics (PK): Volume of distribution at steady state Plasma Pharmacokinetics (PK): Volume of distribution at steady state (Vss)	Up to 7 Days
Number of patients with adverse events as a measure of safety and tolerability		Up to 7 days

Collaborators and Investigators

• Sponsor: Sandoz
• Investigators: Study Director: Sandoz Sandoz, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2017
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: January 11, 2018
• First Posted (Actual): January 16, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 28, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Anemia; Ferric carboxymaltose
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Anemia, Iron-Deficiency; Anemia; Deficiency Diseases
• Other Study ID Numbers: 1637 FCM_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD 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

Drug and device information, study documents

• 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