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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014