Iron Deficiency AnemiaPhase 1NCT03399084
A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia
A Phase 1 study testing Ferric carboxymaltose in people with Iron Deficiency Anemia, run by Sandoz at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Ferric carboxymaltose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2017to 15 Jan 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
This study will evaluate bioequivalence of two formulations of Ferric Carboxymaltose as measured by serum total iron, in adult patients with iron deficiency anemia.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Ferric carboxymaltose
- Keywords
- Ferric carboxymaltose, Anemia
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
750 mg/15 mL
| Study group | Role | What they receive |
|---|---|---|
| Ferric carboxymaltose (test) | Experimental | Patients will receive a single dose of Ferric carboxymaltose Receives: Drug: Ferric carboxymaltose |
| Ferric carboxymaltose (reference) | Active comparator | Patients will receive a single dose of Ferric carboxymaltose Receives: Drug: Ferric carboxymaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron.
Measured by Cmax - The maximum plasma concentration of iron
Measured: 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)
Measured: Up to 7 Days
Secondary outcomes (8)
Maximum serum concentration (Cmax) of serum transferrin-bound iron.
Plasma Pharmacokinetics (PK): The maximum plasma concentration
Measured: Up to 7 days
Time of Cmax (Tmax) of serum total iron and transferrin-bound iron
Plasma Pharmacokinetics (PK): Time of Cmax (Tmax)
Measured: 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)
Measured: Up to 7 Days
Apparent terminal rate constant of serum total iron and transferrin-bound iron
Plasma Pharmacokinetics (PK): Apparent terminal rate constant
Measured: Up to 7 Days
Apparent terminal half-life of serum total iron and transferrin-bound iron
Plasma Pharmacokinetics (PK): Apparent terminal half-life
Measured: Up to 7 Days
Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosing
Plasma Pharmacokinetics (PK): Systemic clearance (CL)
Measured: 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)
Measured: Up to 7 Days
Number of patients with adverse events as a measure of safety and tolerability
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start29 Nov 2017
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandoz Sandoz, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399084
- Sponsor's protocol ID
- 1637 FCM_1
- Status last verified
- May 2019
- First submitted
- 5 Dec 2017
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03399084
- Acronym / sponsor ID
- 1637 FCM_1
- Conditions
- Iron Deficiency Anemia
- Keywords
- Ferric carboxymaltose, Anemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric carboxymaltose (test) | Experimental | Drug: Ferric carboxymaltosePatients will receive a single dose of Ferric carboxymaltose |
| Ferric carboxymaltose (reference) | Active comparator | Drug: Ferric carboxymaltosePatients will receive a single dose of Ferric carboxymaltose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric carboxymaltose750 mg/15 mL | Drug | Ferric carboxymaltose (reference), Ferric carboxymaltose (test) |
Primary outcome
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
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)
8 secondary outcomes
Maximum serum concentration (Cmax) of serum transferrin-bound iron.
Time frame: Up to 7 days
Time of Cmax (Tmax) of serum total iron and transferrin-bound iron
Time frame: Up to 7 Days
Area under the serum concentration-time curve (AUC) of serum transferrin-bound iron
Time frame: Up to 7 Days
Apparent terminal rate constant of serum total iron and transferrin-bound iron
Time frame: Up to 7 Days
Apparent terminal half-life of serum total iron and transferrin-bound iron
Time frame: Up to 7 Days
Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosing
Time frame: Up to 7 Days
Volume of distribution at steady state of serum total iron and transferrin-bound iron following intravenous dosing
Time frame: Up to 7 Days
Number of patients with adverse events as a measure of safety and tolerability
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandoz Sandoz study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ferric carboxymaltose in people with Iron Deficiency Anemia, run by Sandoz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron. (time frame: Up to 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.