Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.

July 12, 2021 updated by: Rockwell Medical Technologies, Inc.

A Randomized 4 Period Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.

This study will investigate the administration of Triferic AVNU intravenously by three different administration schedules compared to continuous infusion over 3 hours

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

An open-label, randomized, four period sequential study of Triferic AVNU administered intravenously by three different administration schedules compared to continuous infusion over 3 hours

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult hemodialysis patients ≥18 years of age.
  • Signed informed consent to participate in the study.
  • Stable on hemodialysis prescription for ≥3 months.
  • Able to sustain hemodialysis 3x/week for 3 to 4 hours.
  • Hemoglobin concentration >9.5 g/dL.
  • Serum TSAT ≥20%.
  • Receiving hemodialysis via AV fistula or graft.
  • Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.
  • Able to receive intermittent heparin administration for anticoagulation of the dialysis circuit.
  • Serum TIBC ≥ 150 µg/dL.

Exclusion Criteria:

  • Active bleeding disorder (GI, skin, nasal…)
  • Receiving hemodialysis via catheter.
  • Receiving IV iron within 10 days of the first on-study hemodialysis treatment.
  • Receiving oral iron within 10 days of the first on-study hemodialysis treatment.
  • Any other condition, that in the opinion of the investigator would not allow completion of the 4 hemodialysis treatments in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Triferic AVNU infusion pre-dialyzer
Patients will receive one (1) 6.75 mg Fe dose of Triferic AVNU by continuous infusion over 3 hours into the predialyzer blood line.
Drug: Triferic
Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.
Other Names:
  • FPC
  • ferric pyrophosphate citrate
Experimental: Triferic AVNU for injection at T=0 and T= 3 hours
Patients will receive two (2) doses of Triferic AVNU 3.4 mg IV (2.25 mL) at T=0 and T=3 hours of hemodialysis into the venous drip chamber.
Drug: Triferic
Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.
Other Names:
  • FPC
  • ferric pyrophosphate citrate
Experimental: Triferic AVNU for injection at T=0
Patients will receive one (1) dose of Triferic AVNU 0.08 mg/kg IV, up to 6.75 mg Fe, at T=0 of hemodialysis into the venous drip chamber.
Drug: Triferic
Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.
Other Names:
  • FPC
  • ferric pyrophosphate citrate
Experimental: Triferic AVNU for injection at T=0, T=1.5 and T= 3 hours
Patients will receive three (3) doses of Triferic AVNU 2.25 mg Fe (1.5 mL) at T=0, T=1.5 and T=3.0 hours of hemodialysis into the venous drip chamber.
Drug: Triferic
Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.
Other Names:
  • FPC
  • ferric pyrophosphate citrate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D
Time Frame: 8 hours
8 hours
Area under plasma transferrin bound plasma iron concentration- time curve (AUC0-last FeTBI) for all Treatments A,B,C and D
Time Frame: 8 hours
8 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Maximum observed plasma iron concentration (Cmax pFetotal) for all Treatments A,B,C and D
Time Frame: 8 hours
8 hours
Maximum observed transferrin bound plasma iron concentration (Cmax FeTBI) for all Treatments A,B,C and D
Time Frame: 8 hours
8 hours
Maximum observed serum iron concentration (Cmax sFetotal) for all Treatments A,B,C and D
Time Frame: 8 hours
8 hours
Area under serum Fe concentration-time curve (AUC0-last sFetotal) for all Treatments A,B,C and D
Time Frame: 8 hours
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rockwell Medical Technologies, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Raymond D Pratt, MD, FACP, Rockwell Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 2, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RMFPC-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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