Phase 2 N=12 Randomized Treatment

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

End Stage Renal Disease

Bottom Line

View on ClinicalTrials.gov: NCT04042324 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2020

Primary outcome: Primary: Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t — .798; .733 IU*hr/mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Triferic (Drug); Heparin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Rockwell Medical Technologies, Inc.
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t	.798; .733	—
SECONDARY Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours	.581; .600; .538	—
SECONDARY aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours	188; 196; 188	—
SECONDARY TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours	97.6; 98.0; 104	—
SECONDARY Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration)	180; 174	—
SECONDARY Iron Profile as Measured by the AUC (Area Under the Curve) 0-t	1040; 1050	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04042324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.