End Stage Renal Disease
Conditions
Brief 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.
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.
DRUGHeparin
Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Sponsors
Rockwell Medical Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t | 8 hours |
Secondary
| Measure | Time frame |
|---|---|
| Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours | 4 hours |
| aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours | 4 hours |
| TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours | 4 hours |
| Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration) | 8 hours |
| Iron Profile as Measured by the AUC (Area Under the Curve) 0-t | 8 hours |
Countries
United States
Participant flow
Pre-assignment details
All twelve participants enrolled in the study were randomly assigned to cross-over between the three treatments on Days 1, 3 and 5.
Participants by arm
| Arm | Count |
|---|---|
| Safety Population All patients enrolled in the study. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Safety Population |
|---|---|
| Age, Continuous | 57.0 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t
Time frame: 8 hours
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| UFH and Triferic Admixture | Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t | .798 IU*hr/mL | Geometric Coefficient of Variation 61.6 |
| UFH Via Continuous Infusion Pre-dialyzer | Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t | .733 IU*hr/mL | Geometric Coefficient of Variation 62.4 |
Secondary
Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours
Time frame: 4 hours
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| UFH and Triferic Admixture | Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours | .581 IU*hr/mL | Geometric Coefficient of Variation 75.7 |
| UFH Via Continuous Infusion Pre-dialyzer | Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours | .600 IU*hr/mL | Geometric Coefficient of Variation 77.9 |
| UFH Via Continuous Infusion Pre-dialyzer | Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours | .538 IU*hr/mL | Geometric Coefficient of Variation 81 |
Secondary
aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
Time frame: 4 hours
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| UFH and Triferic Admixture | aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours | 188 IU*hr/mL | Geometric Coefficient of Variation 37.7 |
| UFH Via Continuous Infusion Pre-dialyzer | aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours | 196 IU*hr/mL | Geometric Coefficient of Variation 38.5 |
| UFH Via Continuous Infusion Pre-dialyzer | aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours | 188 IU*hr/mL | Geometric Coefficient of Variation 39.8 |
Secondary
Iron Profile as Measured by the AUC (Area Under the Curve) 0-t
Time frame: 8 hours
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| UFH and Triferic Admixture | Iron Profile as Measured by the AUC (Area Under the Curve) 0-t | 1040 h*ug/dL | Geometric Coefficient of Variation 31.1 |
| UFH Via Continuous Infusion Pre-dialyzer | Iron Profile as Measured by the AUC (Area Under the Curve) 0-t | 1050 h*ug/dL | Geometric Coefficient of Variation 43.4 |
Secondary
Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration)
Time frame: 8 hours
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| UFH and Triferic Admixture | Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration) | 180 ug/dL | Geometric Coefficient of Variation 20.9 |
| UFH Via Continuous Infusion Pre-dialyzer | Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration) | 174 ug/dL | Geometric Coefficient of Variation 31.5 |
Secondary
TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
Time frame: 4 hours
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| UFH and Triferic Admixture | TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours | 97.6 IU*hr/mL | Geometric Coefficient of Variation 31.6 |
| UFH Via Continuous Infusion Pre-dialyzer | TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours | 98.0 IU*hr/mL | Geometric Coefficient of Variation 34.6 |
| UFH Via Continuous Infusion Pre-dialyzer | TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours | 104 IU*hr/mL | Geometric Coefficient of Variation 40.1 |