Pharmacokinetic of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin

Open-label Multicenter, Pharmacokinetic Study of a Single Dose of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: Iron Sucrose injection

Detailed Description

This is an open-label, multicenter pharmacokinetic study of HD of adolescent PD patients receiving erythropoietin. Patients between the ages of 12 and 18 were administered 100mg of iron sucrose, undiluted by slow IV push over 5 minutes, and underwent serial blood draws. The patients were subsequently followed for 7 days for safety endpoints.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 12 and 18 years
• History of Chronic Renal Failure requiring HD or PD
• Hgb </= 13 g/dL
• Ferritin < 800 ng/ml
• Transferrin Saturation (TSAT) < 50%
• Receiving epoetin

Exclusion Criteria:

• Known Sensitivity to Iron Sucrose
• Severe Concomitant disease of the liver or cardiovascular system
• Serious bacterial Infection
• Pregnancy / Lactation
• Active Hepatitis
• Patients with Causes of iron deficiency other that Chronic Renal Failure
• Blood Transfusion
• Body Weight < 25 kilograms
• Currently being treated for Asthma
• Received investigational drug within last 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iron Sucrose; A single 100 mg dose (1 vial), 20 mg/min injected over 5 minutes	Drug: Iron Sucrose injection; Iron sucrose 100 mg dose; Other Names: Venofer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Body Clearance (CL)	CL refers to the Dose/AUC 0-∞	0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
Volume of Distribution (Vd)	Vd refers to the ratio of amount of drug in a body (dose) to concentration of the drug that is measured in blood, plasma, and un-bound in interstitial fluid.	0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes

Collaborators and Investigators

• Sponsor: American Regent, Inc.
• Investigators: Study Director: Mark A Falone, MD, American Regent, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2002
• Primary Completion (Actual): September 15, 2003
• Study Completion (Actual): September 15, 2003

Study Registration Dates

• First Submitted: October 13, 2005
• First Submitted That Met QC Criteria: October 13, 2005
• First Posted (Estimated): October 17, 2005

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Anemia
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Ferric Oxide, Saccharated
• Other Study ID Numbers: 1VEN01016