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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
  Hide Participant Flow

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
  Hide 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. ]

Measure Type Primary
Measure Title Maximum Observed Serum Concentration (Cmax)
Measure Description No text entered.
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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Measured Values
    Venofer (Iron Sucrose Injection)  
Number of Participants Analyzed  
[units: participants]
 		  9  
Maximum Observed Serum Concentration (Cmax)  
[units: ug/dL]
Mean ± Standard Deviation 		  8545.33  ± 4118.54  

No statistical analysis provided for Maximum Observed Serum Concentration (Cmax)



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. ]

Measure Type Primary
Measure Title Time to Maximum Serum Concentration (Tmax)
Measure Description No text entered.
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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Measured Values
    Venofer (Iron Sucrose Injection)  
Number of Participants Analyzed  
[units: participants]
 		  9  
Time to Maximum Serum Concentration (Tmax)  
[units: hour]
Mean ± Standard Deviation 		  0.56  ± 0.17  

No statistical analysis provided for Time to Maximum Serum Concentration (Tmax)



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. ]

Measure Type Primary
Measure Title Serum Terminal Phase Elimination Half-life (T1/2)
Measure Description No text entered.
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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Measured Values
    Venofer (Iron Sucrose Injection)  
Number of Participants Analyzed  
[units: participants]
 		  8  
Serum Terminal Phase Elimination Half-life (T1/2)  
[units: hour]
Mean ± Standard Deviation 		  8.04  ± 4.51  

No statistical analysis provided for Serum Terminal Phase Elimination Half-life (T1/2)



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. ]

Measure Type Primary
Measure Title Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)
Measure Description No text entered.
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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Measured Values
    Venofer (Iron Sucrose Injection)  
Number of Participants Analyzed  
[units: participants]
 		  9  
Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)  
[units: ug*hr/dL]
Mean ± Standard Deviation 		  31304.84  ± 9850.48  

No statistical analysis provided for Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)



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. ]

Measure Type Primary
Measure Title Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)
Measure Description No text entered.
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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Measured Values
    Venofer (Iron Sucrose Injection)  
Number of Participants Analyzed  
[units: participants]
 		  8  
Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)  
[units: ug/dL]
Mean ± Standard Deviation 		  36293.39  ± 12228.76  

No statistical analysis provided for Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)



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. ]

Measure Type Primary
Measure Title Terminal Phase Elimination Rate Constant (λz)
Measure Description No text entered.
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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Measured Values
    Venofer (Iron Sucrose Injection)  
Number of Participants Analyzed  
[units: participants]
 		  8  
Terminal Phase Elimination Rate Constant (λz)  
[units: 1/hour]
Mean ± Standard Deviation 		  0.15  ± 0.15  

No statistical analysis provided for Terminal Phase Elimination Rate Constant (λz)



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. ]

Measure Type Secondary
Measure Title Total Body Clearance (Cl)
Measure Description Total body clearance: Cl = Dose/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, 12 hours.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Measured Values
    Venofer (Iron Sucrose Injection)  
Number of Participants Analyzed  
[units: participants]
 		  8  
Total Body Clearance (Cl)  
[units: dL/hour]
Mean ± Standard Deviation 		  6.03  ± 1.81  

No statistical analysis provided for Total Body Clearance (Cl)



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. ]

Measure Type Secondary
Measure Title Initial Volume of Distribution (Vdc)
Measure Description No text entered.
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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Measured Values
    Venofer (Iron Sucrose Injection)  
Number of Participants Analyzed  
[units: participants]
 		  9  
Initial Volume of Distribution (Vdc)  
[units: dL]
Mean ± Standard Deviation 		  22.46  ± 14.12  

No statistical analysis provided for Initial Volume of Distribution (Vdc)



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. ]

Measure Type Secondary
Measure Title Volume of Distribution Based on the Terminal Phase (Vdarea)
Measure Description No text entered.
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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Measured Values
    Venofer (Iron Sucrose Injection)  
Number of Participants Analyzed  
[units: participants]
 		  8  
Volume of Distribution Based on the Terminal Phase (Vdarea)  
[units: dL]
Mean ± Standard Deviation 		  63.83  ± 30.28  

No statistical analysis provided for Volume of Distribution Based on the Terminal Phase (Vdarea)



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. ]

Measure Type Secondary
Measure Title Volume of Distribution at Steady State (Vdss)
Measure Description No text entered.
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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Measured Values
    Venofer (Iron Sucrose Injection)  
Number of Participants Analyzed  
[units: participants]
 		  8  
Volume of Distribution at Steady State (Vdss)  
[units: dL]
Mean ± Standard Deviation 		  40.27  ± 20.00  

No statistical analysis provided for Volume of Distribution at Steady State (Vdss)



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. ]

Measure Type Secondary
Measure Title Mean Residence Time (MRtime)
Measure Description No text entered.
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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Measured Values
    Venofer (Iron Sucrose Injection)  
Number of Participants Analyzed  
[units: participants]
 		  8  
Mean Residence Time (MRtime)  
[units: hour]
Mean ± Standard Deviation 		  7.16  ± 4.08  

No statistical analysis provided for Mean Residence Time (MRtime)



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 ]

Measure Type Secondary
Measure Title Number of Participants With Serious Adverse Events (SAE's)
Measure Description No text entered.
Time Frame Day of initial treatment with Venofer through 30 days after study treatment  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Measured Values
    Venofer (Iron Sucrose Injection)  
Number of Participants Analyzed  
[units: participants]
 		  11  
Number of Participants With Serious Adverse Events (SAE's)  
[units: participants]
 		  0  

No statistical analysis provided for Number of Participants With Serious Adverse Events (SAE's)




  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  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