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Completed

NCT Number: NCT00239616

Pharmacokinetic 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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iron Sucrose Injection

Drug

Iron sucrose 100 mg dose

Other names: Venofer

Primary outcomes

  1. Maximum Measured Plasma Concentration (Cmax)

    Time frame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes

    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.

  2. Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC 0-t)

    Time frame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes

    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

  3. Area Under the Curve From Time Zero Extrapolated to Infinity (AUC 0-∞)

    Time frame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes

    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.

  4. Terminal Elimination Half-life (T1/2)

    Time frame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes

    T1/2 refers to the time taken for concentration of a drug to decrease from its maximum concentration to half of Cmax

Secondary outcomes

  1. Total Body Clearance (CL)

    Time frame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes

    CL refers to the Dose/AUC 0-∞

  2. Volume of Distribution (Vd)

    Time frame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes

    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.

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Oct 17, 2005
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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