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The main purpose is to establish the equivalence of Triferic iron administered via dialysate into the arterial blood line and into the venous blood line
An open-label, four period, randomized, crossover study of Triferic iron administered via hemodialysis compared to Triferic administered intravenously pre- and post- hemodialyzer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triferic via Hemodialysate | Experimental | Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session. |
|
| Triferic via IV infusion( pre-dialyzer) | Experimental | Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via arterial blood line (pre-dialyzer) |
|
| Triferic via IV infusion (post-dialyzer) | Experimental | Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via venous blood line (post-dialyzer) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triferic | Drug | ferric pyrophosphate citrate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of Triferic Iron Administered Via Hemodialysate in Adult CKD-5HD Patients: Cmax. | The PK will be done by assessing the mean Cmax of total serum iron from Triferic administered via hemodialysate, compared to Triferic administered at a fixed IV dose of 6.6 mg iron/kg during a single dialysis session. | 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours |
| Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients:Cmax | 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours | |
| Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients: AUC(0-end). | The PK will be done by assessing the mean AUC(0-end) of total serum iron from Triferic administered via hemodialysate, compared to Triferic administered at a fixed IV dose of 6.5 mg iron/kg during a single dialysis session. | 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Incidence of Treatment Emergent Serious Adverse Events | Safety will be documented by recording the incidence of treatment-emergent serious adverse events (TESAEs).The number of patients that experienced treatment emergent serious adverse events will be quantified. Please see the adverse event table for specifics. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Marbury | Orlando Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
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All 27 participants in the study were randomly assigned to cross-over between the three treatments on Day 3, Day 8 and Day 10.
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| ID | Title | Description |
|---|---|---|
| FG000 | Triferic Via Hemodialysate (Day 3) | Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session. |
| FG001 | Triferic Via IV Infusion( Pre-dialyzer) (Day 8) | Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via arterial blood line (pre-dialyzer) |
| FG002 | Triferic Via IV Infusion (Post-dialyzer) (Day 10) | Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via venous blood line (post-dialyzer) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Triferic Via Hemodialysate (Day 3) |
| |||||||||||||
| Triferic Via IV Infusion (Day 8) |
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| Triferic Via IV Infusion (Day 10) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety Population | All patients in study |
| 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 | Pharmacokinetics (PK) of Triferic Iron Administered Via Hemodialysate in Adult CKD-5HD Patients: Cmax. | The PK will be done by assessing the mean Cmax of total serum iron from Triferic administered via hemodialysate, compared to Triferic administered at a fixed IV dose of 6.6 mg iron/kg during a single dialysis session. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ug/dL | 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours |
|
Adverse events will be recorded on the AE CRF from the start of HD #1 (Day 1) through the end of study participation or 7 days after the last dose of Triferic (Day 10).
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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 Via Hemodialysate | Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session. Triferic: ferric pyrophosphate citrate |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MEDDRA (20.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | MEDDRA (20.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ray Pratt | Rockwell Medical | 248 960-9009 | 405 | 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 | Sep 18, 2017 | Jul 1, 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 |
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| ID | Term |
|---|---|
| C049051 | ferric pyrophosphate |
| C032360 | spleen fibrinolytic proteinase (human) |
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|
| From the start of the HD #1 through the end of study participation or 7 days after the last dose of Triferic, whichever is later, assessed up to 2 months |
| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients:Cmax | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ug/dL | 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours |
|
|
|
| Primary | Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients: AUC(0-end). | The PK will be done by assessing the mean AUC(0-end) of total serum iron from Triferic administered via hemodialysate, compared to Triferic administered at a fixed IV dose of 6.5 mg iron/kg during a single dialysis session. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ug/dL | 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours |
|
|
|
| Secondary | Safety Endpoint: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Incidence of Treatment Emergent Serious Adverse Events | Safety will be documented by recording the incidence of treatment-emergent serious adverse events (TESAEs).The number of patients that experienced treatment emergent serious adverse events will be quantified. Please see the adverse event table for specifics. | Posted | Count of Participants | Participants | From the start of the HD #1 through the end of study participation or 7 days after the last dose of Triferic, whichever is later, assessed up to 2 months |
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|
| 0 |
| 27 |
| 1 |
| 27 |
| 1 |
| 27 |
| EG001 | Triferic Via IV Infusion( Pre-dialyzer) | Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via arterial blood line (pre-dialyzer) Triferic: ferric pyrophosphate citrate | 0 | 27 | 2 | 27 | 0 | 27 |
| EG002 | Triferic Via IV Infusion (Post-dialyzer) | Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via venous blood line (post-dialyzer) Triferic: ferric pyrophosphate citrate | 0 | 27 | 0 | 27 | 1 | 27 |
| Cardiac arrest | Cardiac disorders | MEDDRA (20.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MEDDRA (20.0) | Systematic Assessment |
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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 |