Safety, Pharmacokinetics (PK), And Hematological Activity Of AMD3100 (Plerixafor) In Subjects With Renal Impairment

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00445302
First received: March 7, 2007
Last updated: February 10, 2014
Last verified: February 2014
Results First Received: December 12, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Impairment
Intervention: Drug: plerixafor

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Cohort enrollment into the study was staged based on baseline creatinine clearance levels, with moderate renal impairment and control participants enrolled first. Severe renal impairment were enrolled following completion of the moderate renal impairment. Participants with mild renal impairment were enrolled last.

Reporting Groups
  Description
Normal Renal Function Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Mild Renal Impairment Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Moderate Renal Impairment Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Severe Renal Impairment Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.

Participant Flow:   Overall Study
    Normal Renal Function     Mild Renal Impairment     Moderate Renal Impairment     Severe Renal Impairment  
STARTED     6     5     6     6  
COMPLETED     6     5     6     6  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Normal Renal Function Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Mild Renal Impairment Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Moderate Renal Impairment Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Severe Renal Impairment Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Total Total of all reporting groups

Baseline Measures
    Normal Renal Function     Mild Renal Impairment     Moderate Renal Impairment     Severe Renal Impairment     Total  
Number of Participants  
[units: participants]
  6     5     6     6     23  
Age  
[units: years]
Mean ± Standard Deviation
  42.3  ± 5.50     56.2  ± 14.45     65.0  ± 5.83     55.7  ± 11.98     54.7  ± 12.51  
Gender  
[units: participants]
         
Female     2     3     2     4     11  
Male     4     2     4     2     12  
Race/Ethnicity, Customized  
[units: participants]
         
Caucasian     1     3     3     5     12  
African-American     4     1     2     1     8  
Hispanic/Latino     1     1     1     0     3  



  Outcome Measures
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1.  Primary:   Dose-Normalized Maximum Concentration of Plerixafor (Cmax)   [ Time Frame: Pre-dose of plerixafor to 24 hours post-plerixafor ]

2.  Primary:   Dose-Normalized Area Under the Plerixafor Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24h)   [ Time Frame: Pre-dose of plerixafor to 24 hours post-plerixafor ]

3.  Secondary:   Change From Baseline in Absolute CD34+ Cell Counts at Day 2   [ Time Frame: Baseline, Day 2 ]

4.  Secondary:   Change From Baseline in Absolute White Blood Cell (WBC) Counts at Day 2   [ Time Frame: Baseline and Day 2 ]

5.  Secondary:   Number of Participants in Overall Safety Summary of Adverse Events (TEAE)   [ Time Frame: up to Day 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Genzyme Medical Information
Organization: Genzyme Corporation
phone: 1-800-745-4447


No publications provided


Responsible Party: Medical Monitor, Genzyme
ClinicalTrials.gov Identifier: NCT00445302     History of Changes
Other Study ID Numbers: AMD31001101
Study First Received: March 7, 2007
Results First Received: December 12, 2010
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration