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The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacokinetic Population | Experimental | All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venofer | Drug | Single dose of 7mg intravenous (IV) of iron per kg of body weight for a maximum of 200mg iron IV. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. | |
| Time to Maximum Serum Concentration (Tmax) | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. | |
| Serum Terminal Phase Elimination Half-life (T1/2) | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. | |
| Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last) | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. | |
| Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞) | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. | |
| Terminal Phase Elimination Rate Constant (λz) | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Body Clearance (Cl) | Total body clearance: Cl = Dose/Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞) | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours. |
| Initial Volume of Distribution (Vdc) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luitpold Pharmaceuticals | Norristown | Pennsylvania | 19403 | United States |
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Recruitment period: January 2006 to July 2008 Location: Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Venofer (Iron Sucrose Injection) | All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Venofer (Iron Sucrose Injection) | All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Maximum Observed Serum Concentration (Cmax) | Posted | Mean | Standard Deviation | ug/dL | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. |
|
|
Day of initial treatment with Venofer through 30 days after study treatment
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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 | Venofer (Iron Sucrose Injection) | All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MedDRA (11.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark A. Falone, MD | Luitpold Pharmaceuticals, Inc. | 610-650-4200 | mfalone@luitpold.com |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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| Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. |
| Volume of Distribution Based on the Terminal Phase (Vdarea) | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. |
| Volume of Distribution at Steady State (Vdss) | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. |
| Mean Residence Time (MRtime) | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. |
| Number of Participants With Serious Adverse Events (SAE's) | Day of initial treatment with Venofer through 30 days after study treatment |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Time to Maximum Serum Concentration (Tmax) | Posted | Mean | Standard Deviation | hour | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. |
|
|
|
| Primary | Serum Terminal Phase Elimination Half-life (T1/2) | Posted | Mean | Standard Deviation | hour | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. |
|
|
|
| Primary | Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last) | Posted | Mean | Standard Deviation | ug*hr/dL | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. |
|
|
|
| Primary | Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞) | Posted | Mean | Standard Deviation | ug/dL | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. |
|
|
|
| Primary | Terminal Phase Elimination Rate Constant (λz) | Posted | Mean | Standard Deviation | 1/hour | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. |
|
|
|
| Secondary | Total Body Clearance (Cl) | Total body clearance: Cl = Dose/Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞) | Posted | Mean | Standard Deviation | dL/hour | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours. |
|
|
|
| Secondary | Initial Volume of Distribution (Vdc) | Posted | Mean | Standard Deviation | dL | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. |
|
|
|
| Secondary | Volume of Distribution Based on the Terminal Phase (Vdarea) | Posted | Mean | Standard Deviation | dL | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. |
|
|
|
| Secondary | Volume of Distribution at Steady State (Vdss) | Posted | Mean | Standard Deviation | dL | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. |
|
|
|
| Secondary | Mean Residence Time (MRtime) | Posted | Mean | Standard Deviation | hour | Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours. |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events (SAE's) | Posted | Number | participants | Day of initial treatment with Venofer through 30 days after study treatment |
|
|
|
| 0 |
| 11 |
| 1 |
| 11 |
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| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |