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

NCT00239616 | Completed Phase 2

• 1 other identifier: 1VEN01016
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anemia

Keywords

Anemia; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

Study Arms (1)

Iron Sucrose

EXPERIMENTAL

A single 100 mg dose (1 vial), 20 mg/min injected over 5 minutes

Drug: Iron Sucrose injection

Interventions

Iron Sucrose injection DRUG

Iron sucrose 100 mg dose

Also known as: Venofer

Iron Sucrose

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Regent, Inc.: lead

MeSH Terms

Conditions

Anemia

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Mark A Falone, MD

  American Regent, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2005
• First Posted: October 17, 2005
• Study Start: June 5, 2002
• Primary Completion: September 15, 2003
• Study Completion: September 15, 2003
• Last Updated: May 18, 2025

Record last verified: 2018-01