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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre- Dialyzer Infusion and Post- Dialyzer Infusion | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triferic AVNU | Drug | Ferric Pyrophosphate Citrate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | On Days 1, 3, and 5, up to 3 hours |
| 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. | On Days 2, 4, and 6, up to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond D Pratt, MD, FACP | Rockwell Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luxury Dialysis | Webster | Texas | 77598 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | hours | On Days 1, 3, and 5, up to 3 hours |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre- 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. Triferic AVNU: Ferric Pyrophosphate Citrate |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raymond D Pratt, MD | Rockwell Medical | 2489609009 | rpratt@rockwellmed.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2020 | Dec 17, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| 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 |
| up to 3 hours |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | hours | On Days 2, 4, and 6, up to 3 hours |
|
|
|
| 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 | Posted | Mean | Standard Deviation | percentage of saturation | up to 3 hours |
|
|
|
| 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 | Posted | Mean | Standard Deviation | percentage of saturation | up to 3 hours |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Post- Dialyzer Infusion | 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 | 0 | 12 | 0 | 12 | 0 | 12 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |