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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
Results First Received: February 23, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anemia
Intervention: Drug: Venofer

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: January 2006 to July 2008 Location: Hospital

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Venofer (Iron Sucrose Injection) All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.

Participant Flow:   Overall Study
    Venofer (Iron Sucrose Injection)  
STARTED     11  
COMPLETED     11  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Venofer (Iron Sucrose Injection) All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.

Baseline Measures
    Venofer (Iron Sucrose Injection)  
Number of Participants  
[units: participants]
 		  11  
Age  
[units: participants]
 		 
<=18 years     11  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  13.5  ± 1.51  
Gender  
[units: participants]
 		 
Female     6  
Male     5  
Region of Enrollment  
[units: participants]
 		 
Mexico     11  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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. ]
  Show Outcome Measure 1

2.  Primary:   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. ]
  Show Outcome Measure 2

3.  Primary:   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. ]
  Show Outcome Measure 3

4.  Primary:   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. ]
  Show Outcome Measure 4

5.  Primary:   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. ]
  Show Outcome Measure 5

6.  Primary:   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. ]
  Show Outcome Measure 6

7.  Secondary:   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. ]
  Show Outcome Measure 7

8.  Secondary:   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. ]
  Show Outcome Measure 8

9.  Secondary:   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. ]
  Show Outcome Measure 9

10.  Secondary:   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. ]
  Show Outcome Measure 10

11.  Secondary:   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. ]
  Show Outcome Measure 11

12.  Secondary:   Number of Participants With Serious Adverse Events (SAE's)   [ Time Frame: Day of initial treatment with Venofer through 30 days after study treatment ]
  Show Outcome Measure 12


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: David Bregman, M.D., Ph.D.
Organization: Luitpold Pharmaceuticals, Inc.
phone: 610-650-4200
e-mail: dbregman@lpicrd.com


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