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Completed

NCT Number: NCT04409132

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

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triferic

Drug

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: ferric pyrophosphate citrate, FPC

Primary outcomes

  1. Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D

    Time frame: 8 hours

  2. 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

Secondary outcomes

  1. Maximum observed plasma iron concentration (Cmax pFetotal) for all Treatments A,B,C and D

    Time frame: 8 hours

  2. Maximum observed transferrin bound plasma iron concentration (Cmax FeTBI) for all Treatments A,B,C and D

    Time frame: 8 hours

  3. Maximum observed serum iron concentration (Cmax sFetotal) for all Treatments A,B,C and D

    Time frame: 8 hours

  4. Area under serum Fe concentration-time curve (AUC0-last sFetotal) for all Treatments A,B,C and D

    Time frame: 8 hours

Sponsors and collaborators

Lead sponsor

Rockwell Medical Technologies, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2020
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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