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Completed

NCT Number: NCT04042324

A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients

This study will investigate the effect of co-administration of Triferic and heparin on the ability to maintain circuit anti-coagulation and iron delivery when compared to control conditions when each treatment is administered via separate routes.

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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

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.
  • Hemoglobin concentration >9.5 g/dL.
  • Serum TSAT ≥20%.
  • Able to receive continuous heparin infusion as their anticoagulation protocol.
  • Receiving hemodialysis via AV (arteriovenous) fistula or graft.
  • Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.

Exclusion criteria

  • Active bleeding disorder (GI, skin, nasal…)
  • Receiving hemodialysis via catheter.
  • Receiving heparin free dialysis.
  • Receiving low molecular weight heparin as sole anti-coagulation for dialysis.
  • Receiving IV iron within 2 weeks of the first on-study hemodialysis treatment.
  • Receiving oral anti-coagulants or anti-platelet agents.
  • Any other condition, that in the opinion of the investigator would not allow completion of the 3 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

Heparin

Drug

Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.

Other names: Unfractionated heparin, UFH

Primary outcomes

  1. Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t

    Time frame: 8 hours

Secondary outcomes

  1. Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours

    Time frame: 4 hours

  2. aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours

    Time frame: 4 hours

  3. TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours

    Time frame: 4 hours

  4. Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration)

    Time frame: 8 hours

  5. Iron Profile as Measured by the AUC (Area Under the Curve) 0-t

    Time frame: 8 hours

Sponsors and collaborators

Lead sponsor

Rockwell Medical Technologies, Inc.

Industry

Registry information

Official study title

A Randomized 3 Period Crossover Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 1, 2019
Registry last updated
Dec 2, 2020

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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