End Stage Renal Disease
Conditions
Brief summary
The main purpose of this study is to evaluate the delivery of Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the pre-dialyzer and post-dialyzer blood lines.
Detailed description
This is a single center, multi dose, open label study assessing the delivery of Triferic AVNU administered intravenously to adult patients (\> or equal to 18 years of age) using the Freedom Pump-20 during hemodialysis into the pre-dialyzer and post-dialyzer blood lines.
Interventions
DRUGTriferic AVNU
Ferric Pyrophosphate Citrate
Sponsors
Rockwell Medical Technologies, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant must be 18 years of age inclusive, at the time of signing the informed consent. 2. Receiving chronic hemodialysis for 3-4 hours each session 3x/week. 3. Medically stable according to the investigator opinion 4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
1. Hemodynamically unstable during hemodialysis 2. Evidence of active bleeding from the GI tract.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time for Complete Infusion of 4.5 mL Triferic AVNU Pre-Dialyzer | On Days 1, 3, and 5, up to 3 hours | The syringe pump and flow restrictor tubing has a nominal flow rate of 2 mL/hour. When the tubing is connected to the pre-dialyzer or post dialyzer blood circuit the administration time will vary due to the pressure in the dialyzer blood lines. For a 4.5 mL volume the target administration rate is 2.25 hours. The Product labeling for Triferic AVNU advises the dose (4.5 mL) to be administered over 3 to 4 hours. |
| Time for Complete Infusion of 4.5 mL Triferic AVNU Post-Dialyzer | On Days 2, 4, and 6, up to 3 hours | The syringe pump and flow restrictor tubing has a nominal flow rate of 2 mL/hour. When the tubing is connected to the pre-dialyzer or post dialyzer blood circuit the administration time will vary due to the pressure in the dialyzer blood lines. For a 4.5 mL volume the target administration rate is 2.25 hours. The Product labeling for Triferic AVNU advises the dose (4.5 mL) to be administered over 3 to 4 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean TSAT Max Pre-Dialyzer | up to 3 hours | The maximum Transferrin saturation (TSATmax) for the infusion of FPC into the pre-dialyzer blood line when compared to the TSATmax when FPC is infused into the post-dialyzer blood line is an index of any loss of FPC during transit through the dialyzer (artificial kidney |
| Mean TSAT Max Post-Dialyzer | up to 3 hours | The maximum Transferrin saturation (TSATmax) for the infusion of FPC into the pre-dialyzer blood line when compared to the TSATmax when FPC is infused into the post-dialyzer blood line is an index of any loss of FPC during transit through the dialyzer (artificial kidney |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pre- Dialyzer Infusion and Post- Dialyzer Infusion On study day 1, day 3 and day 5, patients will receive 6.75 mg Fe/4.5 mL Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the pre-dialyzer blood line. On study day 2, day 4 and day 6, patients will receive the 6.75 mg Fe/4.5 mL Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the post dialysis blood line.
Triferic AVNU: Ferric Pyrophosphate Citrate | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Pre- Dialyzer Infusion and Post- Dialyzer Infusion |
|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 12.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 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 | 5 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Time for Complete Infusion of 4.5 mL Triferic AVNU Post-Dialyzer
The syringe pump and flow restrictor tubing has a nominal flow rate of 2 mL/hour. When the tubing is connected to the pre-dialyzer or post dialyzer blood circuit the administration time will vary due to the pressure in the dialyzer blood lines. For a 4.5 mL volume the target administration rate is 2.25 hours. The Product labeling for Triferic AVNU advises the dose (4.5 mL) to be administered over 3 to 4 hours.
Time frame: On Days 2, 4, and 6, up to 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre- Dialyzer Infusion and Post- Dialyzer Infusion | Time for Complete Infusion of 4.5 mL Triferic AVNU Post-Dialyzer | 2.5 hours | Standard Deviation 2.8 |
Primary
Time for Complete Infusion of 4.5 mL Triferic AVNU Pre-Dialyzer
The syringe pump and flow restrictor tubing has a nominal flow rate of 2 mL/hour. When the tubing is connected to the pre-dialyzer or post dialyzer blood circuit the administration time will vary due to the pressure in the dialyzer blood lines. For a 4.5 mL volume the target administration rate is 2.25 hours. The Product labeling for Triferic AVNU advises the dose (4.5 mL) to be administered over 3 to 4 hours.
Time frame: On Days 1, 3, and 5, up to 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre- Dialyzer Infusion and Post- Dialyzer Infusion | Time for Complete Infusion of 4.5 mL Triferic AVNU Pre-Dialyzer | 1.7 hours | Standard Deviation 2 |
Secondary
Mean TSAT Max Post-Dialyzer
The maximum Transferrin saturation (TSATmax) for the infusion of FPC into the pre-dialyzer blood line when compared to the TSATmax when FPC is infused into the post-dialyzer blood line is an index of any loss of FPC during transit through the dialyzer (artificial kidney
Time frame: up to 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre- Dialyzer Infusion and Post- Dialyzer Infusion | Mean TSAT Max Post-Dialyzer | 67 percentage of saturation | Standard Deviation 81 |
Secondary
Mean TSAT Max Pre-Dialyzer
The maximum Transferrin saturation (TSATmax) for the infusion of FPC into the pre-dialyzer blood line when compared to the TSATmax when FPC is infused into the post-dialyzer blood line is an index of any loss of FPC during transit through the dialyzer (artificial kidney
Time frame: up to 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre- Dialyzer Infusion and Post- Dialyzer Infusion | Mean TSAT Max Pre-Dialyzer | 88 percentage of saturation | Standard Deviation 101 |