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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 21, 2008
Last Updated Date	December 1, 2011
Start Date ^ICMJE	January 2006
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 23, 2011)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: July 21, 2008)	Pharmacokinetics assessment
Change History	Complete list of historical versions of study NCT00721188 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 1, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients
Official Title ^ICMJE	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)
Brief Summary	The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Anemia
Intervention ^ICMJE	Drug: Venofer Single dose of 7mg intravenous (IV) of iron per kg of body weight for a maximum of 200mg iron IV.
Study Arm (s)	Experimental: Pharmacokinetic Population All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose. Intervention: Drug: Venofer
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	11
Completion Date	January 2010
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	12 Years to 16 Years
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00721188
Other Study ID Numbers ^ICMJE	1VEN05033
Has Data Monitoring Committee	Not Provided
Responsible Party	Marc Tokars, Luitpold Pharmaceuticals, Inc.
Study Sponsor ^ICMJE	Luitpold Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Luitpold Pharmaceuticals
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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