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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triferic post-dialyzer; UFH via continuous infusion | Experimental | Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis. |
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| UFH and Triferic admixture | Experimental | Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. |
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| UFH via continuous infusion pre-dialyzer | Experimental | Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triferic | Drug | Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. |
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| Measure | Description | Time Frame |
|---|---|---|
| Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t | 8 hours |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Pratt, MD | Rockwell Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
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All twelve participants enrolled in the study were randomly assigned to cross-over between the three treatments on Days 1, 3 and 5.
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| ID | Title | Description |
|---|---|---|
| FG000 | UFH and Triferic Admixture (Day 1) | Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| UFH and Triferic Admixture (Day 1) |
|
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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 | Jul 12, 2019 |
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| Heparin | Drug | Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments. |
|
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| 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 |
| FG001 | Triferic Post-dialyzer; UFH Via Continuous Infusion (Day 3) | Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis. |
| FG002 | UFH Via Continuous Infusion Pre-dialyzer (Day 5) | Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis |
| COMPLETED |
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| NOT COMPLETED |
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| Triferic Post-dialyzer (Day 3) |
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| Triferic Pre-dialyzer (Day 5) |
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All patients enrolled in the study who received any amount of UFH, regardless of how the dose was administered.
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety Population | All patients enrolled in the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t | Posted | Geometric Mean | Geometric Coefficient of Variation | IU*hr/mL | 8 hours |
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| Secondary | Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours | Posted | Geometric Mean | Geometric Coefficient of Variation | IU*hr/mL | 4 hours |
| ||||||||||||||||||||||||||||||||
| Secondary | aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours | Posted | Geometric Mean | Geometric Coefficient of Variation | IU*hr/mL | 4 hours |
| ||||||||||||||||||||||||||||||||
| Secondary | TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours | Posted | Geometric Mean | Geometric Coefficient of Variation | IU*hr/mL | 4 hours |
| ||||||||||||||||||||||||||||||||
| Secondary | Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration) | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/dL | 8 hours |
| ||||||||||||||||||||||||||||||||
| Secondary | Iron Profile as Measured by the AUC (Area Under the Curve) 0-t | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ug/dL | 8 hours |
|
1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit.
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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 | Triferic Post-dialyzer; UFH Via Continuous Infusion | Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG001 | UFH and Triferic Admixture | Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | UFH Via Continuous Infusion Pre-dialyzer | Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments. | 0 | 12 | 0 | 12 | 0 | 12 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raymond Pratt, MD | Rockwell Medical, Inc | 248 960 9009 | 405 | rpratt@rockwellmed.com |
| Jun 19, 2020 |
| 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 |
| 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 |
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| ID | Term |
|---|---|
| C049051 | ferric pyrophosphate |
| C032360 | spleen fibrinolytic proteinase (human) |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | UFH Via Continuous Infusion Pre-dialyzer | Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments. |
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| OG002 | UFH Via Continuous Infusion Pre-dialyzer | Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments. |
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| OG002 | UFH Via Continuous Infusion Pre-dialyzer | Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments. |
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