Phase 2
Completed N=12
A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
Source: ClinicalTrials.gov NCT04042324 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t — .798; .733 IU*hr/mL
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.
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 | — |
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.
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. Informational only — not medical advice.