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Completed

NCT Number: NCT00721188

Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients

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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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Luitpold Pharmaceuticals

Norristown, Pennsylvania, 19403, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > or = 12 to < or = 16 years
  • Parent and/or legal guardian able to give informed consent
  • Subject able to give written assent for participating in the study
  • NDD-CKD defined as: kidney damage for 3 months or longer, or GFR < 60 for 3 months or longer
  • Hemoglobin indicative of anemia
  • Ferritin indicative of iron deficiency anemia
  • If appropriate, subject must be willing to use an accepted form of birth control from time of screening through the follow-up period

Exclusion criteria

  • Known history of hypersensitivity to any component of Venofer
  • Parenteral iron within 14 days of the screening visit
  • Dialysis dependent-CKD
  • Chronic or serious active infection
  • Pregnancy or lactation
  • Subjects with causes of iron deficiency anemia other than CKD
  • Blood transfusion within the last month or anticipated during the study
  • Body weight < 55 pounds
  • Received an investigational drug within 30 days before screening

Treatment and study plan

Venofer

Drug

Single dose of 7mg intravenous (IV) of iron per kg of body weight for a maximum of 200mg iron IV.

Primary outcomes

  1. Maximum Observed Serum Concentration (Cmax)

    Time frame: 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.

  2. Time to Maximum Serum Concentration (Tmax)

    Time frame: 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.

  3. Serum Terminal Phase Elimination Half-life (T1/2)

    Time frame: 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.

  4. Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)

    Time frame: 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.

  5. Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)

    Time frame: 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.

  6. Terminal Phase Elimination Rate Constant (λz)

    Time frame: 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 outcomes

  1. Total Body Clearance (Cl)

    Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours.

    Total body clearance: Cl = Dose/Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)

  2. Initial Volume of Distribution (Vdc)

    Time frame: 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.

  3. Volume of Distribution Based on the Terminal Phase (Vdarea)

    Time frame: 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.

  4. Volume of Distribution at Steady State (Vdss)

    Time frame: 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.

  5. Mean Residence Time (MRtime)

    Time frame: 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.

  6. Number of Participants With Serious Adverse Events (SAE's)

    Time frame: Day of initial treatment with Venofer through 30 days after study treatment

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Official study title

Single-Dose Pharmacokinetics of Venofer (Iron Sucrose Injection) in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients Receiving or Not Receiving Erythropoiesis Stimulating Agents (ESA's)

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
Jul 23, 2008
Registry last updated
Feb 20, 2018

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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