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

This study has been completed.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00721188
First received: July 21, 2008
Last updated: December 1, 2011
Last verified: February 2011
  Purpose

The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.


Condition Intervention Phase
Anemia
Drug: Venofer
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Total body clearance: Cl = Dose/Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)

  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Number of Participants With Serious Adverse Events (SAE's) [ Time Frame: Day of initial treatment with Venofer through 30 days after study treatment ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: January 2006
Study Completion Date: January 2010
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pharmacokinetic Population
All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Drug: Venofer
Single dose of 7mg intravenous (IV) of iron per kg of body weight for a maximum of 200mg iron IV.

  Eligibility

Ages Eligible for Study:   12 Years to 16 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721188

Locations
United States, Pennsylvania
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403
Sponsors and Collaborators
Luitpold Pharmaceuticals
  More Information

No publications provided

Responsible Party: Marc Tokars, Luitpold Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00721188     History of Changes
Other Study ID Numbers: 1VEN05033
Study First Received: July 21, 2008
Results First Received: February 23, 2011
Last Updated: December 1, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Ferric oxide, saccharated
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014