Open-label Multicenter, Pharmacokinetic Study of a Single Dose of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin
Sponsor study identifier
interventional
10
0 countries
N/A
Study Start
June 5, 2002
Actual (reported)Primary Completion
September 15, 2003
Actual (reported)Study Completion
September 15, 2003
Actual (reported)This is an open-label, multicenter pharmacokinetic study of Hemodialysis (HD) or Peritoneal Dialysis (PD) patients receiving erythropoietin. Patients were administered 100mg of iron sucrose undiluted by slow IV push over 5 minutes. Patients underwent serial blood draws and were subsequently followed for 7 days for safety endpoints.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 15, 2003
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 5, 2002
Actual (reported)September 15, 2003
Actual (reported)September 15, 2003
Actual (reported)October 13, 2005
Actual (reported)October 17, 2005
Actual (reported)Maximum Measured Plasma Concentration (Cmax)
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC 0-t)
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUC 0-t is defined as AUC from time 0 to the last data point
0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
Area Under the Curve From Time Zero Extrapolated to Infinity (AUC 0-∞)
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC 0-∞ is defined as area under the concentration vs. time curve from zero to infinity.
0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
Terminal Elimination Half-life (T1/2)
T1/2 refers to the time taken for concentration of a drug to decrease from its maximum concentration to half of Cmax
0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
Total Body Clearance (CL)
0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
Volume of Distribution (Vd)
0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
A single 100 mg dose (1 vial), 20 mg/min injected over 5 minutes
Mark A Falone, MD
American Regent, Inc.
10 participants (actual enrollment reported by the registry).
First Submitted
October 13, 2005
First Posted
October 17, 2005
Study Start
June 5, 2002
Actual (reported)Primary Completion
Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis
Contact the study team to confirm eligibility.
September 15, 2003
Actual (reported)Study Completion
September 15, 2003
Actual (reported)Last Updated
May 18, 2025
Record last verified: 2018-01
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Source: ClinicalTrials.gov.
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