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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00721188
First Posted: July 23, 2008
Last Update Posted: May 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Luitpold Pharmaceuticals
  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
Intervention Model: Single Group Assignment
Masking: None (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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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 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. ]
    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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • Number of Participants With Serious Adverse Events (SAE's) [ Time Frame: Day of initial treatment with Venofer through 30 days after study treatment ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721188


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

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00721188     History of Changes
Other Study ID Numbers: 1VEN05033
First Submitted: July 21, 2008
First Posted: July 23, 2008
Results First Submitted: February 23, 2011
Results First Posted: March 25, 2011
Last Update Posted: May 15, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Ferric oxide, saccharated
Hematinics