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

Rockwell Medical Technologies, Inc.12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease

Interventions

TrifericDRUG

Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.

HeparinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult hemodialysis patients ≥18 years of age. 2. Signed informed consent to participate in the study. 3. Stable on hemodialysis prescription for ≥3 months. 4. Hemoglobin concentration \>9.5 g/dL. 5. Serum TSAT ≥20%. 6. Able to receive continuous heparin infusion as their anticoagulation protocol. 7. Receiving hemodialysis via AV (arteriovenous) fistula or graft. 8. Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods. Exclusion Criteria: 1. Active bleeding disorder (GI, skin, nasal…) 2. Receiving hemodialysis via catheter. 3. Receiving heparin free dialysis. 4. Receiving low molecular weight heparin as sole anti-coagulation for dialysis. 5. Receiving IV iron within 2 weeks of the first on-study hemodialysis treatment. 6. Receiving oral anti-coagulants or anti-platelet agents. 7. Any other condition, that in the opinion of the investigator would not allow completion of the 3 hemodialysis treatments in the study.

Locations (1)

Orlando Clinical Research Center

Orlando, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: 8 hours

Secondary Outcomes

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

Time frame: 4 hours

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

Time frame: 4 hours

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

Time frame: 4 hours

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

Time frame: 8 hours

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

Time frame: 8 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.