End Stage Renal Disease
Conditions
Keywords
Pharmacokinetics
Brief summary
This study will investigate the administration of Triferic AVNU intravenously by three different administration schedules compared to continuous infusion over 3 hours
Detailed description
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
Interventions
DRUGTriferic
Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.
Sponsors
Rockwell Medical Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D | 8 hours |
| Area under plasma transferrin bound plasma iron concentration- time curve (AUC0-last FeTBI) for all Treatments A,B,C and D | 8 hours |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed plasma iron concentration (Cmax pFetotal) for all Treatments A,B,C and D | 8 hours |
| Maximum observed transferrin bound plasma iron concentration (Cmax FeTBI) for all Treatments A,B,C and D | 8 hours |
| Maximum observed serum iron concentration (Cmax sFetotal) for all Treatments A,B,C and D | 8 hours |
| Area under serum Fe concentration-time curve (AUC0-last sFetotal) for all Treatments A,B,C and D | 8 hours |
Countries
United States
Outcome results
None listed