Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered via hemodialysate and via two different intravenous routes in adult patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, randomized single dose study.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 via the hemodialysate over the course of the dialysis treatment. Intervention Drug: Triferic |
|
| Triferic via IV infusion | Experimental | Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via the unused heparin infusion line (pre-dialyzer). Intervention: Drug: Triferic |
|
| Triferic IV infusion | Experimental | Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via an infusion port (post-dialyzer). Intervention: Drug: Triferic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triferic | Drug |
|
|
| 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, 4, 5, 6, 8, 10, and 12 hours |
| Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantified Concentration (AUC(Last)). | The PK will be done by assessing the mean area under the serum concentration-time curve from time zero to the time of the last quantified concentration (AUC(last)) and comparing between Triferic administered via hemodialysate and Triferic administered at a fixed IV dose of 6.6 mg iron/kg (pre-dialyzer and post-dialyzer) during a single dialysis session. | 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Safety will be documented by recording the incidence of treatment-emergent adverse events (TEAEs) | 13 days |
| Number of Participants With Treatment-emergent Serious Adverse Events (TEAEs) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | In this cross-over study, all enrolled participants underwent blood sampling over 12 hours for pharmacokinetic (PK) purposes on Day 1. On Days 3, 8, and 10 participants received the following three treatments in a randomized sequence (one treatment per study day): Triferic 2 micromolar via hemodialysate, Triferic 6.6. mg intravenously pre-dialyzer over 3 hours, and Triferic 6.6 mg intravenously post-dialyzer over 3 hours. Blood sampling was conducted over a 12 hour period on each treatment day for PK purposes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Safety will be documented by recording the incidence of treatment-emergent serious adverse events (TESAEs) |
| 13 days |
| Triferic 2 Micromolar Via Hemodialysate |
|
| Triferic 6.6 mg IV Predialyzer |
|
| Triferic 6.6. mg IV Post-dialyzer |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Safety Population | All 13 participants completed every arm of the study. Therefore, the baseline demographic characteristics of the Safety Population as a whole also reflect the characteristics of each arm of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Height | Mean | Standard Deviation | centimeters |
| |||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||||
| C-reactive protein | Mean | Standard Deviation | milligram/deciliter |
|
| 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 | Mean | Standard Deviation | microgram per deciliter | 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantified Concentration (AUC(Last)). | The PK will be done by assessing the mean area under the serum concentration-time curve from time zero to the time of the last quantified concentration (AUC(last)) and comparing between Triferic administered via hemodialysate and Triferic administered at a fixed IV dose of 6.6 mg iron/kg (pre-dialyzer and post-dialyzer) during a single dialysis session. | While all subjects were included in PK analysis, some PK samples were below the lower limit of quantitation (BLQ) of the bioanalytical lab assay. Therefore, the number of subjects analyzed differs from the overall total number of study participants. | Posted | Mean | Standard Deviation | hours*microgram/deciliter | 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Safety will be documented by recording the incidence of treatment-emergent adverse events (TEAEs) | Safety Population (all enrolled subjects) | Posted | Count of Participants | Participants | 13 days |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Serious Adverse Events (TEAEs) | Safety will be documented by recording the incidence of treatment-emergent serious adverse events (TESAEs) | Safety Population (all enrolled subjects) | Posted | Count of Participants | Participants | 13 days |
|
Not provided
Not provided
Not provided
| 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 via the hemodialysate over the course of the dialysis treatment. Triferic | 0 | 13 | 0 | 13 | 1 | 13 |
| EG001 | Triferic Via IV Infusion Pre-dialyzer | Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via the unused heparin infusion line (pre-dialyzer). | 0 | 13 | 0 | 13 | 2 | 13 |
| EG002 | Triferic IV Infusion Post-dialyzer | Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via an infusion port (post-dialyzer). | 0 | 13 | 0 | 13 | 0 | 13 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
The bioanalytical (ICP MS) assay used for the primary PK analysis was extremely sensitive to hemolyzed samples. The clinical laboratory assay was a better method of quantification for this study.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Rockwell Medical, Inc | 248-960-9009 | sgrimberg@rockwellmed.com |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C049051 | ferric pyrophosphate |
| C032360 | spleen fibrinolytic proteinase (human) |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Triferic IV Infusion Post-dialyzer | Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via an infusion port (post-dialyzer). |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|