Back to resultsA Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia
Primary Purpose
Iron Deficiency Anemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ferric carboxymaltose
Sponsored by
About this trial
This is an interventional other trial for Iron Deficiency Anemia focused on measuring Ferric carboxymaltose, Anemia
Eligibility 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.
Sites / Locations
- Sandoz Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ferric carboxymaltose (test)
Ferric carboxymaltose (reference)
Arm Description
Patients will receive a single dose of Ferric carboxymaltose
Patients will receive a single dose of Ferric carboxymaltose
Outcomes
Primary Outcome Measures
Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron.
Measured by Cmax - The maximum plasma concentration of iron
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)
Secondary Outcome Measures
Maximum serum concentration (Cmax) of serum transferrin-bound iron.
Plasma Pharmacokinetics (PK): The maximum plasma concentration
Time of Cmax (Tmax) of serum total iron and transferrin-bound iron
Plasma Pharmacokinetics (PK): Time of Cmax (Tmax)
Area under the serum concentration-time curve (AUC) of serum transferrin-bound iron
Plasma Pharmacokinetics (PK): area under the serum concentration-time curve (AUC)
Apparent terminal rate constant of serum total iron and transferrin-bound iron
Plasma Pharmacokinetics (PK): Apparent terminal rate constant
Apparent terminal half-life of serum total iron and transferrin-bound iron
Plasma Pharmacokinetics (PK): Apparent terminal half-life
Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosing
Plasma Pharmacokinetics (PK): Systemic clearance (CL)
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)
Number of patients with adverse events as a measure of safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03399084
Brief Title
A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
January 15, 2019 (Actual)
Study Completion Date
January 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
Ferric carboxymaltose, Anemia
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferric carboxymaltose (test)
Arm Type
Experimental
Arm Description
Patients will receive a single dose of Ferric carboxymaltose
Arm Title
Ferric carboxymaltose (reference)
Arm Type
Active Comparator
Arm Description
Patients will receive a single dose of Ferric carboxymaltose
Intervention Type
Drug
Intervention Name(s)
Ferric carboxymaltose
Intervention Description
750 mg/15 mL
Primary Outcome Measure Information:
Title
Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron.
Description
Measured by Cmax - The maximum plasma concentration of iron
Time Frame
Up to 7 days
Title
Bioequivalence assessed by area under the serum concentration-time curve (AUC) of serum total iron.
Description
Plasma Pharmacokinetics (PK) of study medication: Area Under the Plasma Concentration-time Curve (AUC)
Time Frame
Up to 7 Days
Secondary Outcome Measure Information:
Title
Maximum serum concentration (Cmax) of serum transferrin-bound iron.
Description
Plasma Pharmacokinetics (PK): The maximum plasma concentration
Time Frame
Up to 7 days
Title
Time of Cmax (Tmax) of serum total iron and transferrin-bound iron
Description
Plasma Pharmacokinetics (PK): Time of Cmax (Tmax)
Time Frame
Up to 7 Days
Title
Area under the serum concentration-time curve (AUC) of serum transferrin-bound iron
Description
Plasma Pharmacokinetics (PK): area under the serum concentration-time curve (AUC)
Time Frame
Up to 7 Days
Title
Apparent terminal rate constant of serum total iron and transferrin-bound iron
Description
Plasma Pharmacokinetics (PK): Apparent terminal rate constant
Time Frame
Up to 7 Days
Title
Apparent terminal half-life of serum total iron and transferrin-bound iron
Description
Plasma Pharmacokinetics (PK): Apparent terminal half-life
Time Frame
Up to 7 Days
Title
Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosing
Description
Plasma Pharmacokinetics (PK): Systemic clearance (CL)
Time Frame
Up to 7 Days
Title
Volume of distribution at steady state of serum total iron and transferrin-bound iron following intravenous dosing
Description
Plasma Pharmacokinetics (PK): Volume of distribution at steady state Plasma Pharmacokinetics (PK): Volume of distribution at steady state (Vss)
Time Frame
Up to 7 Days
Title
Number of patients with adverse events as a measure of safety and tolerability
Time Frame
Up to 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandoz Sandoz
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Sandoz Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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
Learn more about this trial
A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia
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